Study of bb21217 in Multiple Myeloma
A Phase 1 Study of bb21217, an Anti-BCMA CAR T Cell Drug Product, in Relapsed and/or Refractory Multiple Myeloma
1 other identifier
interventional
72
1 country
11
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 multiple-myeloma
Started Aug 2017
Typical duration for phase_1 multiple-myeloma
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 16, 2017
CompletedFirst Submitted
Initial submission to the registry
September 5, 2017
CompletedFirst Posted
Study publicly available on registry
September 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2022
CompletedNovember 7, 2023
April 1, 2022
5.3 years
September 5, 2017
November 2, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events (AEs), DLTs, and changes in laboratory results
Incidence of adverse events (AEs) and abnormal laboratory test results, including dose limiting toxicities (DLTs)
Day 1 through Month 60
Secondary Outcomes (1)
Disease-specific response criteria
Month 1 through Month 60
Study Arms (1)
bb21217 Experimental Arm
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- ≥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 with previous exposure to PI, IMiDs, and a CD38 antibody. Have undergone at least 2 consecutive cycles of treatment for each therapy, unless PD was the best response to the therapy. Refractory to their last line of therapy.
- Subjects must have measurable disease
You may not qualify if:
- 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.
- Pregnant or lactating women
- Previous history of an allogeneic bone marrow transplantation, treatment with any gene therapy based therapeutic for cancer, or BCMA-targeted therapy
- Inadequate pulmonary function defined as oxygen saturation (SaO2) \<92% on room air
- Subjects who have a history of plasma cell leukemia, active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS, or clinically significant amyloidosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- 2seventy biolead
Study Sites (11)
UCSF Medical Center at Parnassus
San Francisco, California, 94143, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Winship Cancer Insitute, Emory University
Atlanta, Georgia, 30322, United States
University of Chicago
Chicago, Illinois, 60637, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02144, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, 07601, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Related Publications (1)
Madduri D, Parekh S, Campbell TB, Neumann F, Petrocca F, Jagannath S. Anti-BCMA CAR T administration in a relapsed and refractory multiple myeloma patient after COVID-19 infection: a case report. J Med Case Rep. 2021 Feb 19;15(1):90. doi: 10.1186/s13256-020-02598-0.
PMID: 33608053DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anna Truppel-Hartmann, MD
Genetix Biotherapeutics Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2017
First Posted
September 6, 2017
Study Start
August 16, 2017
Primary Completion
December 2, 2022
Study Completion
December 2, 2022
Last Updated
November 7, 2023
Record last verified: 2022-04