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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-004583-26
    Sponsor's Protocol Code Number:LV2020-001
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-08-08
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-004583-26
    A.3Full title of the trial
    A Phase 1 and 2a open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and antitumor activity of LAVA-051 in patients with relapsed or refractory chronic lymphocytic leukemia, multiple myeloma or acute myeloid leukemia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A dose escalation trial to assess the safety and tolerability of multiple doses of the LAVA-051 antibody in patients with chronic lymphocytic leukemia, multiple myeloma or acute myeloid leukemia
    A.3.2Name or abbreviated title of the trial where available
    LAVA
    A.4.1Sponsor's protocol code numberLV2020-001
    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 SponsorLAVA Therapeutics B.V.
    B.1.3.4CountryNetherlands
    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 supportLAVA Therapeutics B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSpecialized Medical Services-oncology BV (Brand name CATO SMS)
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressStationsplein NO 438
    B.5.3.2Town/ citySchiphol
    B.5.3.3Post code1117 CL
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31204350 580
    B.5.5Fax number+31204350 589
    B.5.6E-mailSSUReg@allucent.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 nameLAVA-051
    D.3.2Product code LAVA-051
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeLAVA-051
    D.3.9.3Other descriptive nameLAVA-051
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 No
    D.3.11.3.2Gene therapy medical product No
    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 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 chronic lymphocytic leukemia (CLL), multiple myeloma (MM), or acute myeloid leukemia (AML)
    E.1.1.1Medical condition in easily understood language
    Patients with chronic lymphocytic leukemia, multiple myeloma or acute myeloid leukemia
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1 Dose Escalation
    • To investigate the safety and tolerability of LAVA-051 in patients with relapsed/refractory CLL, MM, or AML
    • To determine the recommended Phase 2a dose (RP2D) of LAVA-051 in patients with relapsed/refractory CLL, MM or AML
    Part 2 Dose Expansion
    • To confirm the safety and tolerability of LAVA-051 in diseases specific dose expansion cohorts.
    E.2.2Secondary objectives of the trial
    Part 1 Dose Escalation and Part 2 Dose Expansion
    • To explore the preliminary antitumor activity of LAVA-051.
    • To evaluate the pharmacokinetics of LAVA-051.
    • To evaluate the immunogenicity of LAVA-051.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient must be 18 years of age inclusive or above, at the time of signing the informed consent
    2. Patients with documented diagnosis of CLL, MM, or AML who have failed to respond to or who have relapsed after prior therapy and are not amenable to standard treatments or for whom no standard treatments are available. Patients may have undergone prior cell therapy
    2.1. CLL/ Small Lymphocytic Lymphoma (SLL) patients:
    2.1.1. Proven disease by the presence of CD5+CD19+CD23+ clonal B cells in blood, bone marrow and/or lymph nodes.
    2.1.2. Patients should meet criteria for requiring therapy (the most recent iwCLL guidelines (39)) and must have measurable disease (measurable lesion > 1.5 cm diameter in at least one dimension) and/or lymphocytosis
    2.1.3. Patients must have failed at least one line of targeted therapy (ibrutinib or venetoclax or similar) and not be amenable to- or for whom no further standard treatment is available
    2.2. MM patients:
    2.2.1. Documented diagnosis of MM and measurable disease (see Appendix 6, Section 13.6.2; measurable disease is defined as serum monoclonal paraprotein (M-protein) ≥ 5 g/L or urine M-protein ≥ 200 mg/24 hours or abnormal free light chain (FLC) ratio with involved FLC > 100 mg/L or proven plasmacytoma by biopsy*)
    2.2.2. Documented progression or refractory multiple myeloma as per the IMWG uniform response criteria (see Appendix 6, Section 13.6.3) following ≥3 prior regimens that include at least one immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 monoclonal antibody in any order.
    * If plasmacytoma is the only measurable parameter, the patient is not allowed to be included in the trial, because of difficult response evaluation.
    2.3. AML patients:
    2.3.1. Patients with relapsed/refractory AML (defined using World Health Organization [WHO] 2016 criteria, WHO classification definition of ≥ 20% blasts) of any type with the exception of acute promyelocytic leukemia (APL; AML M3). [Patients with a myelomonocytic or monocytic lineage (M4, M5) are most likely to be positive for the CD1d expression].
    2.3.2. Patients with relapsed/refractory AML (defined as hematologic relapse, molecular relapse, or primary refractory disease as per ELN 2017 guidelines).
    3. Males or non-pregnant, non-breastfeeding females who are:
    a. Surgically sterile (hysterectomy, bilateral oophorectomy or bilateral salpingectomy, vasectomy).
    b. Female of childbearing potential with a negative pregnancy test prior to first dosing and compliant with a highly effective contraceptive regimen (i.e., pregnancy rate of <1% per year: oral contraceptives, intrauterine device (IUD), intrauterine hormone-releasing systems; refer to Appendix 4, Section 13.4 for more details) from signing of the informed consent form (ICF) through 90 days after the last IMP administration. Abstinence is not considered an adequate contraceptive regimen.
    c. Female, postmenopausal defined as continuous amenorrhea for at least 12 consecutive months without an alternative medical cause and a serum follicle-stimulating hormone (FSH) measurement of > 40 IU/L).
    d. Male, compliant with an effective contraceptive regimen (i.e., use of male condom with female partner and assuring use of an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse with a woman of childbearing potential who is not currently pregnant following from signing of the ICF through 90 days after the last IMP administration; refer to Appendix 4, Section 13.4 for more details) from signing of the ICF through 90 days after the last IMP administration). Abstinence is not considered an adequate contraceptive regimen.
    e. Male, refraining from donating sperm following from signing of the ICF through 90 days after the last IMP administration.
    4. Predicted life-expectancy of ≥ 3 months
    5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    6. Adequate renal function (estimated glomerular filtration rate [eGFR] per local laboratory > 40 mL/min/1.73m2), hepatic function [(total bilirubin ≤ 2 times upper limit of normal (ULN), unless in patients with known Gilbert’s syndrome who must have total bilirubin ≤ 3 times ULN; AST and ALT ≤ 3.0 times ULN] and hematological function (neutrophils ≥ 1 x109/L, unless this is considered due to bone marrow tumor infiltration; platelet count ≥ 75x109/L, unless due to bone marrow tumor infiltration, in which case it must be ≥ 50x109/L)
    7. Capable of giving signed and dated informed consent prior to initiation of any trial-related procedure that is not considered Standard of Care which includes compliance with the requirements and restrictions listed in the ICF and in the protocol
    E.4Principal exclusion criteria
    1. Prior allogeneic bone marrow transplant if the patient still has active acute or chronic graft versus host disease requiring >10 mg prednisone or equivalent corticosteroids.
    2. Concomitant malignancies except carcinoma in situ, basal or squamous cell skin carcinoma. Patients who had no evidence of disease from another primary cancer for 2 or more years are allowed to participate in the trial. Localized non-metastatic prostate cancer, not requiring systemic treatment, and for which no local treatment is planned, is allowed.
    3. Uncontrolled or severe intercurrent medical condition.
    4. Known uncontrolled central nervous system involvement.
    5. Patient has any active-, uncontrolled-, or suspected infection.
    6. A significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the investigator would adversely affect patients' participation in this trial.
    7. Unstable cardiovascular function defined as: (a) symptomatic ischemia, or (b) uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on antiarrhythmic agents are excluded; 1st degree atrioventricular block or asymptomatic left anterior fascicular block/right bundle branch block (will not be excluded), or (c) congestive heart failure New York Heart Association Class ≥ 3, or (d) myocardial infarction within 3 months or (e) QTc > 480 msec using Fredericia's QT correction formula.
    8. Previous treatment with radiotherapy, immunotherapy, investigational product, or chemotherapy in the 2 weeks prior to initial IMP administration.
    9. Previous treatment with an aminobisphosphonate IV (e.g., ibandronate, pamidronate, zoledronate etc) within 4 weeks prior to initial IMP.
    10. Previous treatment of any systemic immunosuppressant within 2 weeks prior to initial IMP administration, with the exception of systemic corticosteroid use up to oral dose of 10 mg prednisolone daily (or equivalent for other steroids).
    11. Previous treatment with live or live attenuated vaccines within 2 weeks prior to initial IMP administration. Other (new) types of vaccines need to be evaluated as to their mode of action.
    12. Previous autologous haematopoietic stem cell transplantation (HSCT) or treatment with Chimeric Antigen Receptor (CAR) T-cell therapy within 6 months prior to initial IMP administration.
    13. Known non-CLL/MM/AML related pre-existing clinically relevant immunodeficiency disorders.
    14. Patients with Richter's transformation are excluded
    15. Positive serological testing for Human Immunodeficiency Virus (HIV) antibody, hepatitis B surface antigen [HBsAg] and hepatitis B core antibody (anti-HBc) negative, and hepatitis C virus antibody. Patients who are positive for anti-HBc or hepatitis C antibody may be included if they have a negative PCR within 6 weeks prior to initial IMP administration. Those who are PCR positive will be excluded.
    16. Known allergies, hypersensitivity, or intolerance to the excipients of the IMP.
    17. Major surgery within 4 weeks of initial IMP administration or planned surgery during the time the patient is expected to participate in the trial.
    18. Known ongoing drug and alcohol abuse in the opinion of the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1 Dose Escalation
    • Frequency and severity of Adverse Events using the Common Terminology Criteria and grading for Adverse Events (CTCAE version 5.0) and American Society for Transplantation and Cellular Therapy (ASTCT) grading for CRS.
    • Frequency and type of DLT.
    Part 2 Dose Expansion
    • Frequency and severity, applying CTCAE and ASTCT grading, of AEs at the respective P2D.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1 AEs are monitored continuously from ICF signature until the FU visit. DLT is defined as an AE and is occurring during Cycle 1 (28 days). Part 2 Anti-tumor response will take place: 1) CLL: screening, Peripheral blood at predose of C1-6D1, CT-scan of neck/chest/abdomen in the C3-4th wk, Peripheral Blood MRD at predose of C4D1, BM biopsy in case of suspected remission based on CT analysis and blood evaluation and EoT. 2) MM: screening, Blood/24-h urine at predose of C1-6D1, BM biopsy in C3-4th wk and for confirmation of CR or at disease progression, CT-scan as clinically indicated to document progression and in the C3-4th wk, PE at predose of C1-6D1, and EoT. 3) AML: screening, Peripheral blood at predose of C1-6D1, BM biopsy in the C3-4th wk, MRD of C4D1 and EoT
    E.5.2Secondary end point(s)
    Part 1 Dose Escalation and Part 2 Dose Expansion
    • Antitumor Response:
    o For CLL patients: Response according to the most recent InternationalWorkshop on Chronic Lymphocytic Leukemia (iwCLL) guideline.
    o For MM patients: Response according to the most recent InternationalMyeloma Working Group (IMWG) criteria.
    o For AML patients: Response according to the most recent most recent European LeukemiaNet (ELN) criteria criteria.
    Part 1 Dose Escalation and Part 2
    • Pharmacokinetic parameters.
    • Presence or development of anti-LAVA-051 antibodies.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK collection: SCR, C1D1 at predose, C1D1 1h after SoI, EoI, 15min after EoI, 30min after EoI, 1h, 1,5h, 2h, 3h, 4h, 6h, 8h and 12h after EoI, 24h, 36h, 48h, 72h and 96h after SoI; C1D2-D4-D6 at predose and EoI; C1D3 predose, EoI, 24h and 48h after SOI; C2D1 predose, EoI, 1h, 2h and 4h after EoI, 24h and 48h after SoI; C3-6D1 predose and EoI; EoT
    PD collection: SCR, C1D1 predose, 2h after EoI, 24h, 48h, 72h and 96h after SoI; C1D2-D4-D6 predose; C1D3 predose, 24h and 48h after SoI; C2D1 predose, 24h and 48h after SoI; C3-6D1 predose; EoT
    Lava antibodies collection: SCR, C1D1, C1D4, C2-6D1 and EoT.
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, immunogenicity, antitumor activity
    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 Yes
    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
    Dose escalation and cohort expansion study
    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.8.3 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    France
    Netherlands
    Spain
    Germany
    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 trial completion is defined as LPLV. For patients still on treatment beyond their maximum planned treatment duration follow up in the trial will end at the date of database lock of Part 2.
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 52
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 82
    F.4.2.2In the whole clinical trial 102
    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)
    At the request of the treating physician and in consultation with the sponsor, continued access to IMP might be offered beyond the planned treatment duration of 24 weeks for individual patients with ongoing disease control provided that there is availability of IMP allocated to this trial
    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 Decision2022-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
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