Clinical Trials /

Study of bb2121 in Multiple Myeloma

NCT02658929

Description:

Study CRB-401 is a 2-part, non-randomized, open label, multi-site Phase 1 study of bb2121 in adults with relapsed/refractory multiple myeloma (MM).

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of bb2121 in Multiple Myeloma
  • Official Title: CRB-401 A Phase 1 Study of bb2121 in BCMA-Expressing Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: CRB-401
  • NCT ID: NCT02658929

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
bb2121bb2121

Purpose

Study CRB-401 is a 2-part, non-randomized, open label, multi-site Phase 1 study of bb2121 in adults with relapsed/refractory multiple myeloma (MM).

Detailed Description

      This is a 2-part, non-randomized, open label, multi-site Phase 1 study. the study design
      consists of 2 parts: Part A (Dose Escalation), in which the RP2D is determined, and Part B
      (Expansion Cohorts), in which subjects are treated with the determined RP2D.

      Following consent, enrolled subjects will undergo a leukapheresis procedure to collect
      autologous mononuclear cells for manufacture of investigational drug product (bb2121).
      Following manufacture of the drug product, subjects will receive lymphodepleting therapy with
      fludarabine and cyclophosphamide prior to bb2121 infusion. All subjects who have received
      bb2121 infusion will be followed for up to 60 months on CRB-401.

      All subjects who complete the study, as well as those who withdraw from the study after
      receiving bb2121 for reasons other than death or meeting the early termination criteria, will
      be asked to continue to undergo long-term follow-up in a companion study for up to 15 years
      after their last bb2121 infusion, with a focus on long-term safety and efficacy.
    

Trial Arms

NameTypeDescriptionInterventions
bb2121Experimentalbb2121 autologous CAR T cells will be infused at a dose ranging from 150 - 450 x 10^6 CAR+ T cells after receiving lymphodepleting chemotherapy
  • bb2121

Eligibility Criteria

        Inclusion Criteria:

          -  18 years of age at the time of signing informed consent

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Subjects must have measurable disease including at least one of the criteria below:

        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 -Women of child-bearing potential (WCBP) must
        have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all
        sexually active male subjects must agree to use effective methods of birth control
        throughout the study

        Part A:

        Diagnosis of MM with relapsed or refractory disease and have had at least 3 different prior
        lines of therapy including proteasome inhibitor (e.g., bortezomib or carfilzomib) and
        immunomodulatory therapy (IMiD; e.g., lenalidomide or pomalidomide), or have "double
        refractory" disease to a proteasome inhibitor and IMiD, defined as progression on or within
        60 days of treatment with these agents

        - Part B: Diagnosis of MM with relapsed or refractory disease with previous exposure to PI
        (e.g., bortezomib or carfilzomib), IMiDs (e.g., lenalidomide or pomalidomide), and
        daratumumab, and refractory (based on IMWG criteria) to their last line of therapy

        Exclusion Criteria:

          -  Subjects with known central nervous system disease

          -  Inadequate hepatic function

          -  Inadequate renal function

          -  Inadequate bone marrow function

          -  Presence of active infection within 72 hours

          -  Significant co-morbid condition or disease which in the judgment of the Investigator
             would place the subject at undue risk or interfere with the study; examples include,
             but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic
             injury, and other conditions

          -  Subjects with second malignancies in addition to myeloma if the second malignancy has
             required therapy in the last 3 years or is not in complete remission

          -  Subjects with a history of class III or IV congestive heart failure or non-ischemic
             cardiomyopathy, unstable angina, myocardial infarction, or ventricular arrhythmia
             requiring medication or mechanical control within the previous 6 months

          -  Known human immunodeficiency virus (HIV) positivity

          -  Subjects who have plasma cell leukemia or clinically significant amyloidosis

          -  Pregnant or lactating women
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of adverse events (AEs) and abnormal laboratory test results, including dose limiting toxicities (DLTs)
Time Frame:Day 1 through Month 60
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Disease-specific response criteria including: complete response (CR), very good partial response (VGPR), and partial response (PR) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma
Time Frame:Day 1 through Month 60
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Celgene

Trial Keywords

  • Multiple Myeloma
  • Efficacy and Safety
  • bb2121
  • CAR T Cell
  • BCMA

Last Updated