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Clinical Trial 19722

Cancer Type: Malignant Hematology
Interventions:bb2121 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Melissa Alsina

Call 813-745-6100
or 1-800-679-0775
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

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)

Inclusion Criteria

  • Participants is ≥ 18 years of age at the time of signing the informed consent form (ICF)
  • 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:
  • - R-ISS stage III AND
  • Early relapse defined as:
  • Cohort 2a: PD >Cohort 2b: PD < 18 months since date of start or initial therapy which must contain at minimum, a proteasome inhibitor, an immunomodulatory agent and dexamethasone Cohort 2c: Participants must have received minimum 3 cycles of induction therapy which must contain at minimum, a proteasome inhibitor, an immunomodulatory agent and dexamethasone. Participants must have had ASCT (single or tandem AND < VGPR (excluding PD) at first assessment between 70 to 110 days after last ASCT, with initial therapy without consolidation and maintenance.

  • Exclusion Criteria

  • Participants used any investigational agents within 14 days of leukapheresis
  • Participants received any of the following within the last 14 days of leukapheresis:
  • 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
  • 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