Clinical Trials /

Study of bb21217 in Multiple Myeloma

NCT03274219

Description:

Study CRB-402 is a 2-part, non-randomized, open label, multi-site Phase 1 study of bb21217 in adults with relapsed/refractory multiple myeloma (MM).

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of bb21217 in Multiple Myeloma
  • Official Title: A Phase 1 Study of bb21217, an Anti-BCMA CAR T Cell Drug Product, in Relapsed and/or Refractory Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: CRB-402
  • NCT ID: NCT03274219

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
bb21217bb21217 Experimental Arm

Purpose

Study CRB-402 is a 2-part, non-randomized, open label, multi-site Phase 1 study of bb21217 in adults with relapsed/refractory multiple myeloma (MM).

Detailed Description

      Part A of the study will be Dose Escalation followed by Part B, an expansion cohort.

      Following consent, enrolled subjects will undergo a leukapheresis procedure to collect
      autologous mononuclear cells for manufacture of investigational drug product (bb21217).
      Following manufacture of the drug product, subjects will receive lymphodepletion prior to
      bb21217 infusion. All subjects will then be followed for up to 60 months in Study CRB-402.

      All subjects who complete the study, as well as those who withdraw from the study after
      receiving bb21217 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.
    

Trial Arms

NameTypeDescriptionInterventions
bb21217 Experimental ArmExperimental
  • bb21217

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

          -  Diagnosis of MM with relapsed or refractory disease and have had at least 3 different
             prior lines of therapy with previous exposure to PI, IMiDs, and a CD38 antibody. Have
             undergone at least 2 consecutive cycles of treatment for each therapy, unless PD was
             the best response to the therapy. Refractory to their last line of therapy.

          -  Subjects must have measurable disease

        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

          -  Subjects with a history of stroke, unstable angina, myocardial infarction, or
             ventricular arrhythmia requiring medication or mechanical control

          -  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

          -  Known human immunodeficiency virus (HIV) positivity

          -  Known hepatitis A virus (HAV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
             positivity with evidence of ongoing infection.

          -  Pregnant or lactating women

          -  Previous history of an allogeneic bone marrow transplantation, treatment with any gene
             therapy based therapeutic for cancer, or BCMA-targeted therapy

          -  Inadequate pulmonary function defined as oxygen saturation (SaO2) <92% on room air

          -  Subjects who have a history of plasma cell leukemia, active plasma cell leukemia,
             Waldenstrom's macroglobulinemia, POEMS, or clinically significant amyloidosis
      
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), DLTs, and changes in laboratory results
Time Frame:Day 1 through Month 60
Safety Issue:
Description:Incidence of adverse events (AEs) and abnormal laboratory test results, including dose limiting toxicities (DLTs)

Secondary Outcome Measures

Measure:Disease-specific response criteria
Time Frame:Month 1 through Month 60
Safety Issue:
Description:Disease-specific response criteria including, but not limited to: 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

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:bluebird bio

Last Updated

July 14, 2020