BCMA Bispecific Antibody Therapy for Post-BCMA CAR T-Cell Therapy Relapse (RECLAIM)
ConditionMultiple Myeloma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical College of Wisconsin
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Prior organ transplant requiring immunosuppressive therapy.
Trial design
Design model
Single group
Treatments tested in this trial
Linvoseltamab
DrugLinvoseltamab is a human IgG4-based bsAb that binds to CD3, a T-cell antigen associated with the TCR complex, and BCMA, which is expressed on the surface of malignant MM B-lineage cells, as well as late-stage B cells and plasma cells.
Treatment groups
34 Participants
are divided into 1 treatment groupGroup A: Linvoseltamab AdministrationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall Response Rate
This is the number of subjects who have a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria.
Time frame
Up to 15 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: