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    Summary
    EudraCT Number:2021-002339-44
    Sponsor's Protocol Code Number:IGM-2323-001
    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:2022-06-14
    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 number2021-002339-44
    A.3Full title of the trial
    A phase 1/2 Open-label, multicenter study evaluating the safety and pharmacokinetics of escalating doses of IGM-2323 in subjects with relapsed/refractory non-Hodgkin lymphomas.
    Studio di fase 1/2 in aperto, multicentrico, teso a valutare la sicurezza e la farmacocinetica di dosi crescenti di IGM-2323 in soggetti con linfomi non-Hodgkin recidivanti/refrattari
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A safety and pharmacokinetic study of IGM-2323 in subjects with relapsed/refractory non-Hodgkin lymphoma
    Studio di sicurezza e farmacocinetica di IGM-2323 in soggetti con linfomi non-Hodgkin recidivanti/refrattari
    A.3.2Name or abbreviated title of the trial where available
    A phase 1/2 Open-label, multicenter study evaluating the safety and pharmacokinetics of escalating d
    Studio di fase 1/2 in aperto, multicentrico, teso a valutare la sicurezza e la farmacocinetica di do
    A.4.1Sponsor's protocol code numberIGM-2323-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04082936
    A.5.4Other Identifiers
    Name:US IND NumberNumber:140504
    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 SponsorIGM Biosciences
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIGM Biosciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIGM Biosciences, Inc.
    B.5.2Functional name of contact pointIGM Clinical Trials
    B.5.3 Address:
    B.5.3.1Street Address325 E. Middlefield Road
    B.5.3.2Town/ cityMountain View, CA
    B.5.3.3Post code94043
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@IGMbio.com
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIGM-2323
    D.3.2Product code [IGM-2323]
    D.3.4Pharmaceutical form Solution for injection/infusion
    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.3.8INN - Proposed INNIGM-2323
    D.3.9.1CAS number 2573121-53-4
    D.3.9.2Current sponsor codeIGM-2323
    D.3.9.4EV Substance CodeSUB235343
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    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
    Relapsed/Refractory (R/R) Non-Hodgkin lymphomas (NHL)
    Linfomi Non-Hodgkin recidivanti/refrattari (R/R)
    E.1.1.1Medical condition in easily understood language
    Adult subjects with relapsed or refractory Non-Hodgkin Lymphoma
    Soggetti adulti affetti da linfomi non-Hodgkin recidivanti o refrettari
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10025311
    E.1.2Term Lymphoma (non-Hodgkin's)
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1
    • To evaluate the safety and tolerability of IGM-2323 in subjects with R/R NHL
    • To determine a maximum tolerated dose (MTD) and/or a recommended Phase 2 dose (RP2D) and schedule of IGM-2323 as a single agent in subjects with R/R NHL

    Phase 2 Expansion
    • To select the optimally efficacious dose of IGM-2323 in subjects with R/R diffuse large B-cell lymphoma (DLBCL) and R/R follicular lymphoma (FL)
    Fase 1
    • Valutare la sicurezza e la tollerabilità di IGM-2323 in pazienti con NHL R/R
    • Determinare una dose massima tollerata (MTD) e/o una dose raccomandata di fase 2 (RP2D) e lo schema di IGM-2323 come singolo agente in soggetti con NHL R/R

    Espansione di fase 2
    • Selezionare la dose efficace ottimale di IGM-2323 in soggetti con DLBCL R/R e FL R/R
    E.2.2Secondary objectives of the trial
    • To evaluate the pharmacokinetic (PK) profile of IGM-2323
    • To evaluate the immunogenicity of IGM-2323
    • To assess preliminary efficacy of IGM-2323 in subjects with R/R NHL
    • To assess preliminary efficacy of IGM-2323 in subjects who have received prior bispecific T-cell engager treatment
    • Valutare il profilo di farmacocinetica (PK) di IGM-2323
    • Valutare l’immunogenicità di IGM-2323
    • Valutare l’efficacia preliminare di IGM-2323 in soggetti con NHL R/R
    • Valutare l’efficacia preliminare di IGM-2323 in soggetti che hanno ricevuto un precedente trattamento con un attivante delle cellule T bispecifico
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • >/= 18 years of age: ECOG PS 0 or 1
    • Relapsed or refractory to at least 2 prior systemic treatment regimens (must include anti-CD20 based chemoimmunotherapy regimen).
    • FL and MZL may be enrolled with at least 2 prior systemic regimens which must have included an anti-CD20 therapy (and without need for a prior chemotherapy regimen).
    • For subjects in Cohort G3, prior CD20 x CD3 bispecific T-cell engagers may be enrolled, provided that they did not have Grade 2 or higher CRS on their previous treatment and completed at least 2 cycles of their prior treatment.
    • At least one bi-dimensionally measurable lesion (>=1.5cm in it's longest dimension by computerized tomography (CT scan)
    • Good organ and bone marrow function, evidenced by laboratory assessments
    • Not eligible for autologous stem cell transplant (DLBCL subjects), due to chemo resistant disease, medically unfit (organ function), or unwilling.

    For the full list, please refer to the protocol.
    - Età >=18 anni: stato di validità ECOG di 0 o 1
    - Recidività o refrattarietà ad almeno 2 precedenti regimi di trattamento sistemici (deve includere un regime chemioimmunoterapico basato su anti-CD20)
    - I soggetti affetti da LF e LZM possono essere arruolati con almeno 2 precedenti regimi sistemici che devono aver incluso una terapia anti-CD20 (e senza necessità di un precedente regime chemioterapico)
    - Per i soggetti nella Coorte G3, possono essere arruolati coloro che presentano anticorpi bispecifici CD20 x CD3 attivanti le cellule T, a condizione che non presentassero CRS di Grado 2 o superiore durante il trattamento precedente e abbiano completato almeno 2 cicli del trattamento precedente
    - Almeno 1 lesione misurabile bidimensionalmente (>=1,5 cm) nella sua dimensione maggiore mediante tomografia tomografia computerizzata (TC)
    - Buona funzionalità degli organi e midollare, come evidenziato da esami di laboratorio
    - soggetto non idoneo al trapianto autologo di cellule staminali (soggetti DLBCL), a causa di malattia chemioresistente, inidoneità dal punto di vista medico (funzionalità degli organi) o indisponibilità

    Per l’elenco completo, fare riferimento al protocollo.
    E.4Principal exclusion criteria
    • Known Double/Triple Hit Lymphoma, CLL, or Richters transformation
    • Known lack of cancer cell CD20 expression by IHC, flow cytometry, gene expression or another assay
    • Prior allogeneic transplant or organ transplant
    • ASCT within 100 days prior to the first IGM-2323 administration.
    • Lack of response to prior treatment with CAR-T therapy, subjects with less than 3 months from prior CAR-T therapy to first dose of IGM-2323, and prior CAR-T therapy only allowed with Medical Monitor approval.

    For the full list, please refer to the protocol.
    - Linfoma double/triple hit noto, LLC o trasformazione di Richters
    - Nota mancanza di espressione delle cellule tumorali CD20 misurata mediante IHC, citometria a flusso, espressione genica o altro test.
    - Precedente trapianto allogenico o trapianto di organo
    - ASCT nei 100 giorni precedenti la prima somministrazione di IGM-2323
    - Mancanza di risposta al trattamento precedente con terapia CAR-T, soggetti con meno di 3 mesi dalla precedente terapia CAR-T alla prima dose di IGM-2323 e precedente terapia con CAR-T, la partecipazione consentita solo con l’approvazione del responsabile del monitoraggio medico.

    Per l’elenco completo, fare riferimento al protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence of adverse events (AEs), serious adverse events (SAEs) and DLT according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5)

    Phase 2 Expansion:
    • Overall response rate (ORR) as determined by study Investigators according to the Lugano Classification in Lymphoma
    - Incidenza degli eventi avversi (EA), degli eventi avversi seri (SAE) e DLT secondo i Criteri terminologici comuni per gli eventi avversi (CTCAE) Versione 5.0 (v5) del National Cancer Institute [Istituto nazionale del cancro] (NCI)

    Espansione di fase 2:
    - Tasso di risposta complessiva (ORR) determinato dagli sperimentatori dello studio in base alla Classificazione di Lugano dei linfomi
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety: first dose up to 30 days after last dose.
    ORR: Week 6, 12, 24, then every 3 months
    Sicurezza: prima dose fino a 30 giorni dopo l'ultima dose
    ORR: Settimana 6, 12, 24, poi ogni 3 mesi
    E.5.2Secondary end point(s)
    • PK: area under the curve, clearance (CL), maximum concentration (Cmax), terminal half-life (t1/2), and volume of distribution (Vd) of IGM-2323
    • Incidence of anti-drug antibodies (ADAs)
    • ORR in Phase 1, duration of response (DOR), and progression free survival (PFS), as determined by study Investigators according to the Lugano Classification in Lymphoma
    • ORR, DOR, and PFS as determined by study Investigators in subjects with prior bispecific T-cell engager treatment
    • Complete response rate (CRR) and duration of CR in all tumor types
    • Overall survival (OS)
    - PK: area sotto la curva, clearance (CL), concentrazione massima (Cmax), emivita terminale (t1/2) e volume di distribuzione (Vd) di IGM-2323
    - Incidenza di anticorpi anti-farmaco (ADA)
    - ORR nella fase 1, durata della risposta (DOR) e sopravvivenza libera da progressione (PFS), come determinati dagli sperimentatori dello studio in base alla Classificazione di Lugano dei linfomi
    - ORR, DOR e sopravvivenza libera da progressione (PFS), come determinati dagli sperimentatori dello studio in soggetti precedentemente in trattamento con anticorpi bispecifici attivanti le cellule T
    - Tasso di risposta completa (CRR) e durata della CR in tutti i tipi di tumore
    - Sopravvivenza complessiva (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK: Refer to PK timepoints in attached Protocol IGM-2323-001, Section 8.8.2.
    ADA: Refer to ADA Assessment timepoints in Protocol IGM-2323-001, Section 8.8.6.
    Survival: First dose until time of death or loss to follow up
    PK: far riferimento ai timepoint PK nel protocollo in allegato IGM-2323-001, Sezione 8.8.2
    ADA: far riferimento ai timepoint di valutazione degli ADA nel protocollo IGM-2323-001, Sezione 8.8.6
    Sopravvivenza: prima dose fino al momento del decesso o perdita al follow up
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    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 Yes
    E.8.1.7.1Other trial design description
    Randomizzato, In aperto
    Randomized, Open
    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 trial7
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Korea, Republic of
    United States
    France
    Spain
    Czechia
    Italy
    E.8.7Trial has a data monitoring committee No
    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
    The end of study is defined as the timepoint when the final data for a clinical study have been collected, which is after the last patient has made the final visit to the study location.
    -
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 260
    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)
    Post-treatment, subjects will be observed for disease progression until next therapy, for drug related SAEs, and survival until death or until withdrawal of consent, or the end of the study, whichever occurs first. Based upon further review of available safety, PK, PD, and efficacy, length of IGM-2323 treatment may be extended.
    -
    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 Decision2022-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-20
    P. End of Trial
    P.End of Trial StatusOngoing
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