BCMA Bispecific Antibody Therapy for Post-BCMA CAR T-Cell Therapy Relapse (RECLAIM) (NCT07009899) | Clinical Trial Compass
Not Yet RecruitingPhase 2
BCMA Bispecific Antibody Therapy for Post-BCMA CAR T-Cell Therapy Relapse (RECLAIM)
United States34 participantsStarted 2026-07-01
Plain-language summary
This is a single-center, single-arm, phase 2 study designed to evaluate the efficacy and safety of linvoseltamab in multiple myeloma (MM) patients who relapsed following BCMA CAR T-cell therapy, whether standard of care or investigational.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status criteria of 0-3.
✓. Received any standard of care or investigational BCMA CAR T-cell therapy as their last line of therapy ≥ 6 months prior to enrollment.
✓. Must have measurable disease for response assessment as per the IMWG response assessment criteria.
✓. Adequate hepatic function as defined below:
✓. Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN).
✓. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN.
✓. Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion criteria
✕. Previously on a BCMA-directed therapy other than BCMA CAR T-cell therapy (e.g., BCMA bispecific antibody, BCMA antibody drug conjugate) or T cell engaging therapy (e.g., GPRC5D bispecific antibody, GPRC5D CAR T-cell therapy).
✕. History of neurodegenerative condition, Central Nervous System (CNS) movement disorder, or patients with a history of seizure within 12 months prior to study enrollment.
✕. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
What they're measuring
1
Overall Response Rate
Timeframe: Up to 15 months
Trial details
NCT IDNCT07009899
SponsorMedical College of Wisconsin
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2028-02-01
Contact for this trial
Medical College of Wisconsin Cancer Center Clinical Trials Office