Medical College of Wisconsin
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.
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. The primary objective is to assess overall response rate (ORR) in patients treated with linvoseltamab.
Inclusion Criteria: 1. Age ≥18 years. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status criteria of 0-3. 3. Received any standard of care or investigational BCMA CAR T-cell therapy as their last line of therapy ≥ 6 months prior to enrollment. a. Note: Up to 15% of patients who are \< 6 months out from their standard of care of investigational BCMA CAR T-cell therapy will be included in the study as long as i) their bone marrow biopsy sample tests positive for BCMA expression by immunohistochemistry and ii) they have stem cells available for a stem cell boost therapy prior to…
Linvoseltamab 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.
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