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    Summary
    EudraCT Number:2019-001264-30
    Sponsor's Protocol Code Number:CARAMBA-1
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-02
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-001264-30
    A.3Full title of the trial
    A phase I/IIa clinical trial to assess feasibility, safety and antitumor activity of autologous SLAMF7 CAR-T cells in multiple myeloma
    Studio clinico di fase I/IIa per valutare la fattibilità, la sicurezza e l'attività antitumorale delle cellule CAR-T SLAMF7 autologhe nel mieloma multiplo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase I/IIa clinical trial to assess feasibility, safety and antitumor activity of autologous SLAMF7 CAR-T cells in multiple myeloma
    Studio clinico di fase I/IIa per valutare la fattibilità, la sicurezza e l'attività antitumorale delle cellule CAR-T SLAMF7 autologhe nel mieloma multiplo
    A.3.2Name or abbreviated title of the trial where available
    SLAMF7 CAR-T in multiple myeloma
    SLAMF7 CAR-T nel mieloma multiplo
    A.4.1Sponsor's protocol code numberCARAMBA-1
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04499339
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversitätsklinikum Würzburg
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEuropean Union
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Ospedale San Raffaele
    B.5.2Functional name of contact pointUfficio Ricerche Ciniche - Stem Cel
    B.5.3 Address:
    B.5.3.1Street AddressVia Olgettina, 60
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number00390226434289
    B.5.6E-mailciceri.clinicaltrials@hsr.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/17/1833
    D.3 Description of the IMP
    D.3.1Product nameSLAMF7 CAR-T
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeSLAMF7 CAR-T
    D.3.10 Strength
    D.3.10.1Concentration unit thousand organisms/ml thousand organisms/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Multiple myeloma (MM)
    Mieloma Multiplo (MM)
    E.1.1.1Medical condition in easily understood language
    Plasma cell cancer
    Tumore Cellule Plasmatiche
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1) Phase I: Safety determination of the treatment with SLAMF7 CAR-T
    2) Phase I: Determination of the MTD and the recommended phase IIa dose of SLAMF7 CAR-T
    3) Phase IIa: Safety determination of the treatment with SLAMF7 CART
    4) Phase IIa: Evaluation of the efficacy, defined as overall response rate (ORR) of SLAMF7 CAR-T in patients with MM
    1) Fase I: Determinazione della sicurezza del trattamento con CAR-T SLAMF7
    2) Fase I: Determinazione dell'MTD e della dose raccomandata di fase IIa di CAR-T SLAMF7 in pazienti con MM
    3) Fase IIa: Determinazione della sicurezza del trattamento con CAR-T SLAMF7
    4) Fase IIa: Valutazione dell'efficacia, definita come tasso di risposta globale (ORR) delle cellule CAR-T SLAMF7 in pazienti con MM
    E.2.2Secondary objectives of the trial
    1) Evaluation of the complete response (CR) of SLAMF7 CAR-T in patients with MM
    2) Determination of the feasibility to ex vivo manufacture of autologous SLAMF7 CAR-T and to administer to patients with MM
    3) Determination of the expansion and duration of in vivo persistence of adoptively transferred SLAMF7 CAR- T cells in peripheral blood, bone marrow and tumor tissue
    4) To determine if the adoptive transfer of SLAMF7 CAR-T has an antimyeloma effect
    5) Determination of the SLAMF7 CAR-T cells impact on patient's overall survival (OS)
    6) To determine if the adoptive transfer of SLAMF7 CAR-T affects the quality of life
    1) Valutazione della risposta completa (CR) a CAR-T SLAMF7 in pazienti con MM
    2) Determinazione della fattibilità della produzione ex vivo di cellule autologhe CAR-T SLAMF7 e della loro somministrazione in pazienti con MM
    3) Determinazione dell'espansione e della persistenza in vivo delle cellule CAR-T SLAMF7 infuse, misurate nel sangue periferico, nel midollo osseo e nel tessuto tumorale
    4) Determinare se il trasferimento adottivo di CAR-T SLAMF7 ha un effetto anti-mieloma
    5) Determinazione dell'impatto delle cellule CAR-T SLAMF7 sulla sopravvivenza globale (OS) del paziente
    6) Determinare se il trasferimento adottivo di CAR-T SLAMF7 influisce sulla qualità della vita correlata alla salute (HRQoL)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent form
    2. Patient is >=18 years of age
    3. Patient is willing and able to adhere to the protocol requirements
    4. Patient with diagnosis of MM who has been treated with at least 2 prior lines of treatment, including at least one cycle of high-dose chemotherapy with autologous hematopoietic stem cell transplantation if the patient was eligible, and exposure to an immunomodulatory imide drug (e.g. lenalidomide and/or pomalidomide), a proteasome inhibitor,
    and/or an anti-CD38 antibody.
    5. At least one of the following subcriteria must be measured in the patient:
    - Serum M-protein greater or equal to 0.5 g/dL
    - Urine M-protein greater or equal to 200 mg/24 h
    - Serum free light chain (FLC) assay: involved FLC level greater or equal to 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal
    - A biopsy-proven evaluable plasmacytoma
    - Bone marrow plasma cells >10% of total bone marrow cells (>30% if bone marrow plasma cells are the only marker of measurable disease)
    6. Patients previously treated with an anti-SLAMF7 antibody are eligible.
    7. Karnofsky performance status >=60%. If patient has a Karnofsky performance status <60% (e.g. after a spinal cord injury) but is judged to be medically fit by the investigator, patient is eligible.
    8. Female patients of childbearing potential must:
    a) have a negative pregnancy test (blood) at screening.
    b) either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with, effective measures of contraception without interruption, from screening through 1 year following the IMP infusion. A highly effective method of contraception or birth control (failure rate less than 1% per year when used consistently and
    correctly) must be practiced.
    c) Agree to abstain from breast feeding during the study participation and for 1 year after the IMP infusion.
    9. Male patients must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential for at least 1 year after IMP infusion, even if he has undergone
    a successful vasectomy.
    1. Consenso informato firmato
    2. Età >=18 anni
    3. Paziente che esprime la volontà di partecipare al protocollo ed è in grado di aderire ai requisiti del protocollo
    4. Diagnosi di MM che è stato trattato con almeno 2 precedenti linee di trattamento, incluso almeno un ciclo di chemioterapia ad alte dosi con trapianto di cellule staminali ematopoietiche autologhe se il paziente era eleggibile ed esposizione a un farmaco immunomodulante (es. lenalidomide e/o pomalidomide), un inibitore del proteasoma e un anticorpo anti-CD38
    5. Almeno uno dei seguenti sottocriteri deve essere valutabile nel paziente:
    - Proteina M sierica maggiore o uguale a 0,5 g/dL
    - Proteina M urinaria maggiore o uguale a 200 mg/24 h
    - Saggio per dosaggio delle catene leggere libere sieriche (FLC): livello di FLC coinvolta maggiore o uguale a 10 mg/dL (100 mg/L) a condizione che il rapporto sierico di FLC sia alterato
    - Plasmocitoma valutabile confermato in biopsia
    - Plasmacellule midollari > 10% delle cellule del midollo osseo totale (> 30% se le plasmacellule del midollo osseo sono l'unico marker di malattia misurabile).
    6. Sono ammessi pazienti precedentemente trattati con un anticorpo anti-SLAMF7.
    7. Performance status (PS) secondo Karnofsky >=60%. Se il paziente ha un PS <60% (ad es. a causa di una lesione midollare) ma è ritenuto idoneo dal punto di vista medico dallo sperimentatore, il paziente è ammesso.
    8. Le pazienti in età fertile devono:
    - avere un test di gravidanza negativo su sangue allo screening.
    - impegnarsi nell’astinenza dal contatto eterosessuale o accettare di utilizzare ed essere in grado di rispettare misure efficaci di contraccezione senza interruzione, dallo screening fino a 1 anno dopo l'infusione dell’IMP. Deve essere praticato un metodo contraccettivo o anticoncezionale altamente efficace (tasso di fallimento inferiore all'1% all'anno se usato in modo coerente e corretto).
    - Accettare di astenersi dall'allattamento durante la partecipazione allo studio e per 1 anno dopo l'infusione dell’IMP.
    9. I pazienti di sesso maschile devono praticare la vera astinenza o accettare di usare un preservativo durante il contatto sessuale con una donna incinta o una donna in età fertile per almeno 1 anno dopo l'infusione dell’IMP, anche se hanno subito una vasectomia.
    E.4Principal exclusion criteria
    1. Patient has undergone a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning <=12 months prior to leukapheresis.
    2. Patient has undergone a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning >12 months, and suffers on chronic Graft-versus-Host Disease and/or is on systemic immune-suppressants.
    3. Patient with diagnosis of MM
    a. in first relapse following an autologous stem cell transplantation or
    b. in second relapse that subsequently achieves a complete response that is considered being a candidate for an allogeneic stem cell transplantation, unless the patient explicitly denies undergoing an allogeneic stem cell transplantation.
    4. Patient has received anti-CD38 and/or anti-SLAMF7 antibodies <=8 weeks prior to leukapheresis.
    5. Ongoing treatment with systemic immune-suppressants (e.g. systemic cyclosporine or systemic steroids at any dose).
    6. Echocardiogram with left ventricular ejection fraction <45%.
    7. Inadequate renal function defined by creatinine clearance <=45 mL/min using Cockcroft-Gault equation.
    8. Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN) and total bilirubin >1.5 x ULN (unless due to Gilbert’s syndrome and direct bilirubin is <=1.5 x ULN; unless due to intrahepatic myeloma lesions as demonstrated by magnetic resonance imaging [MRI] or positron emission tomography [PET]/computed tomography [CT] not older than 4 weeks prior to screening).
    9. International ratio (INR) or partial thromboplastin time (PTT) >1.5 x ULN, unless on a stable dose of anti-coagulant.
    10. Evidence of human immunodeficiency virus (HIV) infection.
    11. Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV), excluding
    - Patients who are hepatitis B surface antigen negative and HBV viral deoxyribonucleic acid (DNA) negative
    - Patients who had hepatitis B but have received an antiviral treatment and show non-detectable viral DNA for 6 months
    - Patients who are seropositive because of hepatitis B virus vaccine
    - Patients with known HBV infection but undetectable HBV viral load and on anti-viral therapy to prevent HBV reactivation.
    12. Seropositive for and with active viral infection with hepatitis C virus (HCV), excluding
    - Patients who had hepatitis C but had received an antiviral treatment and show no detectable HCV viral ribonucleic acid (RNA) for 6 months.
    13. Seropositive for syphilis on treponema pallidum hemagglutination test, excluding
    - Patients with negative treponema pallidum antibody absorption test result
    14. Patients with active infection (e.g. asymptomatic and symptomatic severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] infection) or other serious medical or psychiatric disorder on investigators decision.
    15. Pregnant or lactating women.
    16. Current or previous (within 30 days of enrollment) treatment with another IMP.
    17. Known abuse of alcohol, drugs, or medicinal products.
    18. Employees of the sponsor, or employees or relatives of the investigator.
    1. Il paziente è stato sottoposto ad un precedente trapianto di cellule staminali allogeniche con condizionamento standard o ad intensità ridotta <=12 mesi prima della leucoaferesi
    2. Il paziente ha subito un precedente trapianto di cellule staminali allogeniche con condizionamento standard o ad intensità ridotta > 12 mesi ma è affetto da Graft versus host Disease (GvHD) cronica e/o è in terapia con immunosoppressori sistemici
    3. Paziente con diagnosi di MM
    a. in prima recidiva a seguito di un trapianto di cellule staminali autologhe o
    b. in seconda recidiva con successivo ottenimento di una risposta completa, considerato candidato a trapianto di cellule staminali allogeniche, a meno che il paziente non rifiuti esplicitamente di sottoporsi a trapianto di cellule staminali allogeniche.
    4. Il paziente ha ricevuto anticorpi anti-CD38 e/o anti-SLAMF7 <=8 settimane prima della leucoaferesi.
    5. Trattamento in corso sistemico con immunosoppressori (ad es. Ciclosporina sistemica o steroidi sistemici a qualsiasi dose).
    6. Ecocardiogramma con frazione di eiezione ventricolare sinistra <45%.
    7. Funzione renale inadeguata definita da clearance della creatinina <=45 mL/min secondo l'equazione di Cockcroft-Gault.
    8. Funzione epatica inadeguata definita da aspartato aminotransferasi (AST) e/o alanina aminotransferasi (ALT) > 2,5 x limite superiore di norma (ULN) e bilirubina totale > 1,5 x ULN (salvo a causa di nota sindrome di Gilbert, con bilirubina diretta <=1,5 x ULN; salvo a causa di lesioni mielomatose intraepatiche come dimostrato da risonanza magnetica [MRI] o tomografia ad emissione di positroni [PET]/tomografia computerizzata [CT] eseguite non oltre le 4 settimane prima dello screening).
    9. Rapporto internazionale (INR) o tempo parziale di tromboplastina (PTT) > 1,5 x ULN, salvo in caso di trattamento continuo con anticoagulante
    10. Evidenza di infezione da virus dell'immunodeficienza umana (HIV).
    11. Sieropositività per e infezione attiva virale grave da virus dell’epatite B (HBV), esclusi:
    - Pazienti che sono negativi per l'antigene di superficie dell'epatite B (HBsAg) e negativi per il DNA virale dell'HBV
    - Pazienti che hanno avuto l'epatite B ma hanno ricevuto un trattamento antivirale e mostrano DNA virale non rilevabile per 6 mesi
    - Pazienti sieropositivi a causa del vaccino contro il virus dell'epatite B.
    - Pazienti con infezione da HBV nota ma carica virale di HBV non rilevabile e in terapia anti-virale per prevenire la riattivazione virale.
    12. Sieropositività per e infezione attiva virale da virus dell'epatite C (HCV), esclusi:
    - Pazienti che hanno contratto l'epatite C ma hanno ricevuto un trattamento antivirale e non hanno mostrato RNA virale rilevabile per 6 mesi.
    13. Sieropositività per la sifilide nel test di emoagglutinazione con Treponema pallidum, esclusi
    - Pazienti con risultato negativo del test di assorbimento dell'anticorpo Treponema pallidum
    14. Pazienti con infezione attiva (es. infezione sintomatica e asintomatica da coronavirus 2 da sindrome respiratoria acuta grave [SARS-CoV-2]) o altri gravi disturbi medici o psichiatrici su decisione degli investigatori.
    15. Donne in gravidanza o in allattamento.
    16. Trattamento attuale o precedente (entro 30 giorni dall’arruolamento) con un altro farmaco sperimentale.
    17. Abuso noto di alcol, droghe o farmaci.
    18. Dipendenti dello sponsor o dipendenti o parenti dello sperimentatore
    E.5 End points
    E.5.1Primary end point(s)
    1) Phase I: Type, frequency, and severity of adverse events (AEs), including serious adverse events (SAEs), cytokine release syndrome (CRS), and neurotoxicity (i.e. immune effector cell-associated neurotoxicity syndrome [ICANS])
    2) Phase I: MTD of SLAMF7 CAR-T that can be administered in phase IIa will be assessed at the end of phase I
    3) Phase IIa: Type, frequency, and severity AEs, including SAEs, CRS, and neurotoxicity (i.e. ICANS)
    4) Phase IIa: Percentage of patients who achieved partial response (PR) or better using the IMWG Uniform Response Criteria for MM at Months 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 after SLAMF7 CAR-T infusion
    1) Fase I: Tipo, frequenza e gravità degli eventi avversi (AE), inclusi eventi avversi severi (SAE), sindrome da rilascio di citochine (CRS) e neurotossicità (sindrome da neurotossicità associata alle cellule immuno effettrici [ICANS])
    2) Fase I: L'MTD di CAR-T SLAMF7 che può essere somministrata nella fase IIa sarà valutata alla fine della fase I
    3) Fase IIa: Tipo, frequenza e gravità di eventi avversi, inclusi SAE, CRS e neurotossicità (es. ICANS)
    4) Fase IIa: Percentuale di pazienti che hanno ottenuto una risposta parziale (PR) o superiore utilizzando i criteri di risposta secondo IMWG per MM ai mesi 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21 e 24 dopo l’infusione di CART SLAMF7
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) D0, 4 hours after infusion, D1 to D28, W5, W6, W7, W8, W10, W12, M4 to M12, M15, M18, M24
    2) End of phase I
    3) D0, 4 hours after infusion, D1 to D28, W5, W6, W7, W8, W10, W12, M4 to M12, M15, M18, M24
    4) M1 to M6, M9, M12, M15, M18, M21, M24
    1) G0, 4 ore dopo l'infusione, dal G1 al G28, Settimana 5-6-7-8-10-12, dal Mese 4 al Mese 12, Mese 15-18-24
    2) Fine della Fase I
    3) G0, 4 ore dopo l'infusione, dal G1 al G28, Settimana 5-6-7-8-10-12, dal Mese 4 al Mese 12, Mese 15-18-24
    4) Dal Mese 1 al Mese 6, Mese 12-15-21-24
    E.5.2Secondary end point(s)
    1) Phase IIa: Percentage of patients who achieved CR or better using the IMWG Uniform Response Criteria for MM at Months 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 after SLAMF7 CAR-T infusion
    2) Phase I and IIa: Percentage of MM patients enrolled into the trial who receive ex vivo expanded autologous SLAMF7 CAR-T within the 48h shelf-life of the product
    3) Phase I and IIa: Maximum peak in SLAMF7 CAR-T (Cmax), time to peak of SLAMF7 CAR-T (Tmax), area under the curve of CAR-T CD4+ and CD8+ cells (AUC), including maximum expansion and duration of persistence of SLAMF7 CAR-T cells at Baseline, Days 1, 3, 7, 10, 14, 21, 28, Week 6, 8, 12, Months 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24
    4.) Phase I and IIa:
    a) Time between first SLAMF7 CAR-T infusion and first documentation of response at Months 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24;
    b) Time between first response and disease progression PD or death at Months 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24
    c) Time between SLAMF7 CAR-T infusion and first documentation of PD or death at Months 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24
    d) Proportion of minimal residual disease (MRD) evaluable patients that are MRD negative (defined at a minimum of 1 in 105 nucleated cells) using flow cytometry at Months 1, 3, 6, 12, 24
    5) Phase I and IIa: Time between SLAMF7 CAR-T infusion and time of death at Months 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24
    6) Phase I and IIa: Patient-reported outcomes as measured by EORTC-QLQ-C30/-MY20 at Screening, Baseline, Months 6, 12, 24
    1) Fase IIa: Percentuale di pazienti che hanno raggiunto CR o superiore utilizzando i criteri di risposta secondo IMWG per MM ai mesi 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21 e 24 dopo infusione di CAR-T SLAMF7
    2) Fase I e IIa: Percentuale di pazienti affetti da mieloma arruolati nello studio che ricevono CAR-T SLAMF7 autologhe espanso ex vivo entro le 48 ore di conservabilità del prodotto
    3) Fase I e IIa: Picco massimo di CAR-T SLAMF7 (Cmax), tempo al picco di CAR-T SLAMF7 (Tmax), area sotto la curva delle cellule CAR-T CD4+ e CD8+ (AUC), compresa la massima espansione e durata della persistenza di CAR-T SLAMF7 al basale, giorni 1, 3, 7, 10, 14, 21, 28, settimana 6, 8, 12, mesi 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24
    4) Fase I e IIa:
    a) Tempo tra la prima infusione di CAR-T SLAMF7 e la prima documentazione di risposta ai mesi 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24
    b) Tempo tra la prima risposta e la progressione di malattia (PD) o morte ai mesi 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24
    c) Tempo tra l'infusione di CAR-T SLAMF7 e la prima documentazione di PD o morte ai mesi 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24
    d) Proporzione di pazienti valutabili con malattia minima residua (MRD) che sono MRD negativi (definiti in almeno 1 su 105 cellule nucleate) mediante citometria a flusso ai mesi 1, 3, 6, 12, 24
    5) Fase I e IIa: Tempo tra l'infusione di CAR-T SLAMF7 e il momento della morte ai mesi 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24
    6) Fase I e IIa: HRQoL riportato dal paziente, misurato da EORTC-QLQ-C30/- MY20 allo screening, basale, e ai mesi 6, 12, 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) M1 to M6, M9, M12, M15, M18, M21, M24
    2) D0
    3) Baseline (BL) (D-8), D1, D3, D7, D10, D14, D21, D28, W6, W8, W12, M4 to M12, M15, M18, M21, M24
    4.a) M1 to M6, M9, M12, M15, M18, M21, M24
    4.b) M1 to M6, M9, M12, M15, M18, M21, M24
    4.c) M1 to M6, M9, M12, M15, M18, M21, M24
    4.d) M1, M3, M6, M12, M24
    5) M1 to M6, M9, M12, M15, M18, M21, M24
    6) M6, M12, M24
    1) Dal Mese 1 al Mese 6, Mese 9-12-15-18-21-24
    2) G0
    3) Baseline (G-8), G1-3-7-10-14-21-28, Settimana 6-8-12, Dal Mese 4 al Mese 12, Mese 15-18-21-24
    4.a) Dal Mese 1 al Mese 6, Mese 12-15-18-21-24
    4.b) Dal Mese 1 al Mese 6, Mese 12-15-18-21-24
    4.c) Dal Mese 1 al Mese 6, Mese 12-15-18-21-24
    4.d) Mese 1-3-6-12-24
    5) Dal Mese 1 al Mese 6, Mese 12-15-18-21-24
    6) Mese 6.12.24
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    F.4.2.2In the whole clinical trial 38
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    When their trial participation has ended, patients will receive standard medical care according to their individual needs.
    Al termine della sperimentazione, i pazienti saranno seguiti da pratica clinica
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-01
    P. End of Trial
    P.End of Trial StatusOngoing
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