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219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

Study of bb2121 in Multiple Myeloma

Clinicaltrials.gov identifier NCT02658929

Recruitment Status Active, not recruiting

First Posted January 20, 2016

Last update posted August 21, 2019

Study Description

Brief summary:

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 or Disease:Multiple Myeloma
  • Intervention/Treatment: Biological: bb2121
  • Phase: Phase 1
Detailed Description

This is a 2-part, non-randomized, open label, multi-site Phase 1 study. the study design consists of 2 parts: Part A (Dose Escalation), in which the RP2D is determined, and Part B (Expansion Cohorts), in which subjects are treated with the determined RP2D. 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 lymphodepleting therapy with fludarabine and cyclophosphamide prior to bb2121 infusion. All subjects who have received bb2121 infusion will be followed for up to 60 months on 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 for up to 15 years after their last bb2121 infusion, with a focus on long-term safety and efficacy.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 67 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: CRB-401 A Phase 1 Study of bb2121 in BCMA-Expressing Multiple Myeloma
  • Actual Study Start Date: December 2015
  • Estimated Primary Completion Date: November 2023
  • Estimated Study Completion Date: November 2023
Arms and interventions
Arm Intervention/treatment
Experimental: bb2121
bb2121 autologous CAR T cells will be infused at a dose ranging from 150 - 450 x 10^6 CAR+ T cells after receiving lymphodepleting chemotherapy
Biological: bb2121
Outcome Measures
  • Primary Outcome Measures: 1. Incidence of adverse events (AEs) and abnormal laboratory test results, including dose limiting toxicities (DLTs) [ Time Frame: Day 1 through Month 60 ]
  • Secondary Outcome Measures: 1. Disease-specific response criteria including: overall response rate (ORR), complete response (CR), very good partial response (VGPR), and partial response (PR) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for MM. [ Time Frame: Day 1 through Month 60 ]
    Percentage of subjects who achieved a CR, VGR, PR according to IMWG Uniform Response Criteria for Multiple Myeloma (MM).
Eligibility Criteria
  • 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

- Subjects must have measurable disease including at least one of the criteria below:

Serum M-protein greater or equal to 0.5 g/dL Urine M-protein greater or equal to 200 mg/24
h Serum free light chain (FLC) assay: involved FLC level greater or equal to 10 mg/dL (100
mg/L) provided serum FLC ratio is abnormal -Women of child-bearing potential (WCBP) must
have a negative serum pregnancy test prior to treatment and refrain from tissue donation
including egg donation or any other tissue/blood/organ donations, for at least 1 year
following bb2121 infusion. All sexually active WCBP and all sexually active male subjects
must agree to use effective methods of birth control throughout the study. All sexually
active males subjects must refrain from tissue donation including egg donation or any other
tissue/blood/organ donations, for at least 1 year following bb2121 infusion.

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

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

- 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

- Subjects with second malignancies in addition to myeloma if the second malignancy has
required therapy in the last 3 years or is not in complete remission

- Subjects with a history of class III or IV congestive heart failure or non-ischemic
cardiomyopathy, unstable angina, myocardial infarction, or ventricular arrhythmia
requiring medication or mechanical control within the previous 6 months

- Known human immunodeficiency virus (HIV) positivity

- Subjects who have plasma cell leukemia or clinically significant amyloidosis

- Pregnant or lactating women

Contacts and Locations

United States, California
Stanford Cancer Center

United States, Maryland
National Cancer Institute

United States, Massachusetts
Massachusetts General Hospital

United States, Massachusetts
Beth Israel Deaconess Medical Center

United States, Massachusetts
Dana Farber Cancer Institute

United States, Minnesota
Mayo Clinic

United States, New Jersey
Hackensack University Medical Center

United States, New York
Mt. Sinai Medical Center Division of Hematology/Oncology
New York

United States, Tennessee
Sarah Cannon Research Inst

Sponsors and Collaborators


bluebird bio


Study Director: Kristen Hege, MD Celgene Corporation

More Information