Status:
COMPLETED
Study of bb21217 in Multiple Myeloma
Lead Sponsor:
2seventy bio
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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).
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 cell...
Eligibility Criteria
Inclusion
- ≥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
Exclusion
- 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
Key Trial Info
Start Date :
August 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2022
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03274219
Start Date
August 16 2017
End Date
December 2 2022
Last Update
November 7 2023
Active Locations (11)
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1
UCSF Medical Center at Parnassus
San Francisco, California, United States, 94143
2
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
3
Winship Cancer Insitute, Emory University
Atlanta, Georgia, United States, 30322
4
University of Chicago
Chicago, Illinois, United States, 60637