eligibility_summary
Eligibility: Multiple myeloma (IMWG) with measurable disease, Cohort 1 requires >=3 prior therapy lines with >=1 full cycle and PD or no response to last regimen, ECOG 0-1, POCBP negative serum hCG. Exclusions: prior CAR-T, BCMA- or GPRC5D-directed therapy, allogeneic SCT <6 mo or autologous SCT <12 wks, live vaccine <4 wks, unresolved >Grade 1 toxicities (except alopecia/peripheral neuropathy), stroke/TIA/seizure <6 mo.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 2, open-label, sequential treatment for high-risk relapsed/refractory multiple myeloma. Interventions and mechanisms: 1) Ciltacabtagene autoleucel (cilta-cel, JNJ-68284528) – autologous CAR-T cell therapy given IV. Patient T cells are engineered to express a chimeric antigen receptor targeting BCMA on malignant plasma cells, activating T-cell cytotoxicity and cytokine release to kill BCMA+ myeloma cells. 2) Talquetamab (JNJ-64407564) – subcutaneous bispecific T-cell–redirecting antibody (CD3×GPRC5D). It binds GPRC5D on myeloma cells and CD3 on T cells, recruiting and activating T cells to lyse GPRC5D+ myeloma independent of BCMA. Cells/pathways targeted: BCMA-expressing and GPRC5D-expressing myeloma plasma cells, T-cell activation via CD3, immune synapse formation, T-cell–mediated cytotoxic pathways.