©2022 Stanford Medicine
Study of bb2121 in Multiple Myeloma
Not Recruiting
Trial ID: NCT02658929
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).
Official Title
CRB-401 A Phase 1 Study of bb2121 in BCMA-Expressing Multiple Myeloma
Stanford Investigator(s)
Michaela Liedtke
Associate Professor of Medicine (Hematology)
Eligibility
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
Intervention(s):
biological: bb2121
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061