This is a single-arm, open-label, phase 1b study evaluating the safety and feasibility of using talquetamab as bridging therapy prior to cilta-cel in patients with relapsed and refractory multiple myeloma (RRMM).
Age > 18 years.
Histologically confirmed diagnosis of multiple myeloma with evidence of progressive disease as defined by the IMWG criteria.
Serum M-protein level ≥ 1.0 g/dL, or
Urine M-protein level ≥ 200 mg/24 hours, or
Adoptive T-cell therapy (e.g., CAR T-cell therapy) at any time prior to enrollment.
Bispecific antibody, investigational or approved, irrespective of its target, at any time prior to enrollment.
Use of talquetamab prior to enrollment.
Any therapy targeting BCMA or GPRC5D, including but not limited to antibody-drug conjugates and/or monoclonal antibodies.
Single group
Talquetamab
DrugTalquetamab will be administered subcutaneously.
Ciltacabtagene Autoleucel
DrugCiltacabtagene Autoleucel will be administered intravenously.
The number of subjects without serious adverse events following Ciltacabtagene Autoleucel infusion through Day +30.
SAEs will be assessed using the NCI CTCAE v5.0 during bridging therapy and for 30 days following infusion. Immune-mediated toxicities will be graded and assessed using the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading systems. SAEs that meet the definition of the primary endpoint analysis will include: 1. Any Grade 5 AE. 2. Any Grade ≥ 4 non-hematological treatment-related AE. 3. Cytokine release syndrome (Grade ≥ 3), immune-cell effector associated neurotoxicity syndrome (Grade ≥ 3) or immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) of any grade.
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