Study of bb21217 in Multiple Myeloma

Overview

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 24 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.

SparkCures ID 906
Trial Phase Phase 1
Enrollment 74 Patients
Treatments
Trial Sponsors
  • bluebird bio
NCT Identifier

NCT03274219

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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 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.
  • 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.
  • Subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control
  • Pregnant or lactating women

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Verified John Theurer Cancer Center Hackensack Meridian Health
Verified Winship Cancer Institute of Emory University

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Mayo Clinic (Rochester)

Rochester, MN

California
Florida
Georgia
Verified Winship Cancer Institute of Emory University

SparkCures Verified Accurate, up-to-date information. Learn more

Illinois
Massachusetts
Minnesota
Mayo Clinic (Rochester)

Rochester, MN

New Jersey
Verified John Theurer Cancer Center Hackensack Meridian Health

SparkCures Verified Accurate, up-to-date information. Learn more

New York
Tennessee

Resources