Clinical trial · Interventional
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
NCT03274219CI-TRIAL-00071132completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bb21217 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- bb21217 Experimental Arm
- interventionNames
- Biological: bb21217
Primary outcomes (1)
- measure
- Incidence of adverse events (AEs), DLTs, and changes in laboratory results
- timeFrame
- Day 1 through Month 60
- description
- Incidence of adverse events (AEs) and abnormal laboratory test results, including dose limiting toxicities (DLTs)
Secondary outcomes (1)
- measure
- Disease-specific response criteria
- timeFrame
- Month 1 through Month 60
- description
- • Disease-specific response criteria including, but not limited to: 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥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 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 * 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
References
Publications (1)
- DERIVEDMadduri 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 33608053