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Clinical Trial 19194

Cancer Type:
Interventions:bb21217

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Melissa Alsina

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

Study Title

A Phase 1 Study of bb21217, an anti-BCMA CAR T Cell Drug Product, in Relapsed and/or Refractory Multiple Myeloma

Summary

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). The purpose of this study is to evaluate if gene transfer therapy is a safe and tolerable way to treat the participant's multiple myeloma. The study will also evaluate how well the investigational T cells kill the their tumor cells.

Objective

The primary objectives of the study are: -Determine the maximally tolerated dose (MTD) and a recommended phase 2 dose (RP2D) of bb21217 in subjects with relapsed or refractory multiple myeloma (MM) for future studies. -Confirm the safety of the RP2D. The secondary objective of the study is to: -Provide preliminary efficacy data on the anti-tumor effects of treatment with bb21217 in subjects with MM. The exploratory objectives of the study are to: -Evaluate the overall survival and progression-free survival of subjects treated with bb21217. -Evaluate the persistence, immune phenotype, and function of bb21217 in the blood, bone marrow, and/or tumor tissue. -Evaluate cytokine/chemokine induction in the blood of subjects after infusion of bb21217. -Evaluate the level of BCMA+ cells in blood and bone marrow, and the level of circulating soluble BCMA. -Evaluate measures of tumor sensitivity/resistence to bb21217. -Evaluate minimal residual disease (MRD). -Evaluate the development of an anti-CAR immune response by assessment of anti-CAR antibodies. -Evaluate the utility of the immunohistochemistry (IHC) BCMA expression assay.

Inclusion Criteria

  • ≥18 years of age at the time of signing informed consent
  • Diagnosis of multiple myeloma (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.
  • Participants must have measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

  • Exclusion Criteria

  • Known central nervous system (CNS) disease
  • Inadequate hepatic function
  • Inadequate renal function
  • Inadequate bone marrow function
  • Presence of active infection within 72 hours
  • 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 participant 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.
  • A history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control
  • Women who are pregnant or lactating