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Clinical Trial 19722

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT03601078

Phase: Phase II
Principal Investigator: Alsina, Melissa

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Overview

Study Title

A Phase 2, Multi-Cohort, Open-Label, Multicenter Study To Determine The Efficacy And Safety Of Bb2121 In Subjects With Relapsed And Refractory Multiple Myeloma And In Subjects With High-Risk Multiple Myeloma Having Progressed Within One Year Of Initial Treatment

Summary

This study is a multi-cohort, open-label, multicenter Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory MM (Cohort 1), in subjects with MM having progressed within one 18 months of initial treatment including autologous stem cell transplantation (ASCT) (Cohort 2a), and without ASCT (Cohort 2b) or, in subjects with inadequate response post ASCT during initial treatment (Cohort 2c) Approximately 181 subjects will be enrolled into one of two cohorts. Cohort 1 will enroll approximately 73 RRMM subjects with > 3 prior anti-myeloma treatment regimens. Cohort 2a will enroll approximately 39 MM subjects, with 1 prior anti-myeloma therapy including ASCT and with early relapse. Cohort 2b will enroll approximately 39 MM subjects with 1 prior anti-myeloma therapy not including ASCT and with early relapse. Cohort 2c will enroll approximately 30 MM subjects with inadequate response to ASCT during their initial anti-myeloma therapy. The cohorts will start in parallel and independently.

Objective

Primary Objective: The primary objective of the study is to evaluate the preliminary efficacy of bb2121 in subjects with RRMM and in subjects with HR MM having progressed within one year of initial treatment Secondary Objective: Evaluate the safety of bb2121 in subjects with RRMM and in subjects with HR MM having progressed within one year of initial treatment Evaluate additional efficacy parameters of bb2121 Characterize the expansion and persistence of chimeric antigen receptor (CAR) + T cells, in the peripheral blood and bone marrow (by vector copy number [VCN]) Evaluate the development of an anti-CAR antibody response Evaluate the percentage of subjects who attain minimal residual disease (MRD) negative status (by EuroFlow and next generation sequencing [NGS]) Evaluate changes in health-related quality of life (HRQoL)

Treatments

Therapies

Chemotherapy (NOS); Immunotherapy

Medications

CC-5013 (Lenalidomide); Lenalidomide (Revlimid); bb2121 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Inclusion Criteria

  • Participants is >18 years of age at the time of signing the informed consent form (ICF)
  • For Cohorts 1 and 2 only, Participants has measurable disease
  • Participants with one of the following cohort specific requirements:
  • Cohort 1 RRMM Participants with ≥ 3 prior anti-myeloma treatment regimens:
  • Participants must have received at least 3 prior anti-myeloma treatment regimens. Note: induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen
  • Participants must have undergone at least 2 consecutive cycles of treatment for each regimen, unless PD was the best response to the regimen
  • Participants must have received prior treatment with a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody
  • Participants has evidence of PD on or within 60 days of the most recent prior treatment regimen
  • Participants achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen
  • Cohort 2 Participants with 1 prior anti-myeloma treatment regimen:
  • Participants must have received only 1 prior anti-myeloma treatment regimen. Note: induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen
  • Participants must have the following HR factors:
  • Early relapse defined as:
  • Cohort 2a: PD >Cohort 2b: PD > Cohort 3 participants with newly diagnosed MM:
  • Participant with NDMM who have received only induction and ASCT, without subsequent consolidation or maintenance.
  • Participant must have received 4 to 6 cycles of induction therapy which must contain at minimum, a proteasome inhibitor and an immunomodulatory agent and must have had single ASCT within 6 months prior to consent.
  • Participants must have achieved documented PR or VGPR at first post-ASCT assessment approximately 100 days after ASCT and this response must be maintained at screening.
  • Per Investigator’s assessment, participant must be a candidate for single-agent lenalidomide maintenance.
  • Additional Criteria will apply

  • Exclusion Criteria

  • Participants used any investigational agents within 14 days prior to leukapheresis or for Cohort 3, within 14 days prior to consent
  • Participants received any of the following within the last 14 days prior to leukapheresis or for Cohort 3, within 14 days prior to consent
  • Plasmapheresis
  • Major surgery (as defined by the investigator)
  • Radiation therapy other than local therapy for myeloma associated bone lesions
  • Use of any systemic anti-myeloma drug therapy (NOTE: For Cohort 3 no systemic anti-myeloma drug therapy is allowed after ASCT)
  • Participants with known central nervous system involvement with myeloma
  • Participants has clinical evidence of pulmonary leukostasis and disseminated intravascular coagulation
  • Participants with active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or clinically significant amyloidosis
  • Inadequate organ function Participants with a history of Class III or IV congestive heart failure (CHF) or severe nonischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months prior to starting study treatment
  • Ongoing treatment with chronic immunosuppressants
  • Previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or BCMA targeted therapy
  • Participants has received ASCT within 12 weeks prior to leukapheresis
  • Participants has history of primary immunodeficiency
  • Participants is positive for human immunodeficiency virus (HIV-1), chronic or active hepatitis B or active hepatitis A or C
  • Participants has uncontrolled systemic fungal, bacterial, viral or other infection (including tuberculosis) despite appropriate antibiotics or other treatment
  • Participants with prior history of malignancies, other than MM, unless the Participants has been free of the disease for > 5 years
  • Pregnant or lactating women
  • Participants with known hypersensitivity to any component of bb2121 product, cyclophosphamide, fludarabine, and/or tocilizumab

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