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Study of bb2121 in Multiple Myeloma

This study is currently recruiting participants.
Verified November 2017 by Celgene
Sponsor:
ClinicalTrials.gov Identifier:
NCT02658929
First Posted: January 20, 2016
Last Update Posted: November 14, 2017
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.
Collaborator:
bluebird bio
Information provided by (Responsible Party):
Celgene
  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).

Condition Intervention Phase
Multiple Myeloma Biological: bb2121 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of bb2121 in BCMA-Expressing Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Celgene:

Primary Outcome Measures:
  • Incidence of adverse events (AEs) and abnormal laboratory test results, including dose limiting toxicities (DLTs) [ Time Frame: Day 1 through Month 24 ]

Secondary Outcome Measures:
  • 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: Month 1 through Month 24 ]

Estimated Enrollment: 50
Actual Study Start Date: January 31, 2016
Estimated Study Completion Date: February 28, 2020
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bb2121 Experimental Arm Biological: bb2121
autologous T cells transduced ex-vivo with anti-BCMA02 CAR lentiviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA autologous T cells transduced ex-vivo with anti-BCMA02 CAR lentiviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA, suspended in cryopreservative solution

Detailed Description:

Part A of the study will enroll adults with multiple myeloma using a 3+3 dose escalation approach. An expansion cohort will be enrolled following dose selection.

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 lymphodepletion prior to bb2121 infusion. All subjects will then be followed for up to 24 months in Study 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 LTF-305 for up to 15 years after their last bb2121 infusion, with a focus on long-term safety and efficacy.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • ≥ 18 years of age at the time of signing informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • 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

  • Subjects must have measurable disease
  • 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

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
  • Subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control
  • Pregnant or lactating women
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02658929


Contacts
Contact: bluebird bio clinicaltrials@bluebirdbio.com

Locations
United States, California
Stanford Cancer Center Recruiting
Palo Alto, California, United States, 94305
Contact: Reneth Tien    650-723-0646    rtien@stanford.edu   
Contact: Uzma Ahmed    650-723-0670    uzma.ahmed@stanford.edu   
United States, Maryland
National Cancer Institute Recruiting
Bethesda, Maryland, United States, 20892
Contact: Judith Lawrence    301-827-0022    judith.lawrence@nih.gov   
Contact: Brenna Hansen    301-435-5605    hansenb3@mail.nih.gov   
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Nikhil Munshi, MD    617-632-5607    nikil_munshi@dfci.harvard.edu   
Contact: Robert Schlossman, MD    617-632-5126    Robert_Schlossman@dfci.harvard.edu   
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02144
Contact: Noopur Raje    617-724-4000    nraje@mgh.harvard.edu   
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jacalyn Rosenblatt, MD    617-667-9920    jrosenb1@bidmc.harvard.edu   
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
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Laura McBride       lmcbride@hackensackumc.org   
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: Melissa Sindler, RN    615-335-0190    Melissa.sindler@scresearch.net   
Sponsors and Collaborators
Celgene
bluebird bio
Investigators
Study Director: Kristen Hege, MD Celgene Corporation
  More Information

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02658929     History of Changes
Other Study ID Numbers: CRB-401
First Submitted: January 15, 2016
First Posted: January 20, 2016
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases