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Trial record 1 of 1 for:    bb21217
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Study of bb21217 in Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03274219
Recruitment Status : Recruiting
First Posted : September 6, 2017
Last Update Posted : May 7, 2019
Information provided by (Responsible Party):
bluebird bio

Brief 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).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: bb21217 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of bb21217, an Anti-BCMA CAR T Cell Drug Product, in Relapsed and/or Refractory Multiple Myeloma
Actual Study Start Date : August 16, 2017
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: bb21217 Experimental Arm Biological: bb21217
autologous T cells transduced ex-vivo with anti-BCMA CAR lentiviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA, suspended in cryopreservative solution

Primary Outcome Measures :
  1. Incidence of adverse events (AEs), DLTs, and changes in laboratory results [ Time Frame: Day 1 through Month 60 ]
    Incidence of adverse events (AEs) and abnormal laboratory test results, including dose limiting toxicities (DLTs)

Secondary Outcome Measures :
  1. Disease-specific response criteria [ Time Frame: Month 1 through Month 60 ]
    • 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03274219

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Contact: bluebird bio 339-499-9300

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United States, California
UCSF Medical Center at Parnassus Recruiting
San Francisco, California, United States, 94143
Contact: Julie McCluggage, RN   
United States, Florida
H. Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Alexandria Shrewsbury         
Contact    813-745-8281   
United States, Georgia
Winship Cancer Insitute, Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Rachael L Morffi, MPH, CCRC         
Contact    404-778-1801      
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Andrezj Jakubowiak    773-795-1180   
United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02144
Contact: Noopur Raje, MD    617-726-0711   
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jacalyn Rosenblatt, MD    617-667-9920   
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Nikhil Munshi, MD    617-632-4774   
United States, Minnesota
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Mayo Clinic Clinical Trials Referral Office    855-776-0015      
United States, New Jersey
John Theurer Cancer Center at Hackensack UMC Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Palka Anand, RN, BSN, CCRP         
Contact    551-996-3040      
United States, New York
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Lisa La    212-241-8615   
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact:    615-339-4214      
Sponsors and Collaborators
bluebird bio
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Study Director: Fabio Petrocca, MD bluebird bio

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Responsible Party: bluebird bio Identifier: NCT03274219    
Other Study ID Numbers: CRB-402
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases