eligibility_summary
IMWG-defined multiple myeloma with measurable disease (serum M‑protein ≥0.5 g/dL, urine M‑protein ≥200 mg/24 h, or serum FLC ≥10 mg/dL with abnormal ratio), 1–3 prior lines incl ≥2 cycles each of a PI, lenalidomide, and anti‑CD38 mAb (or ≥6 doses if maintenance only), PD/nonresponse to last line, ECOG 0–2, WOCBP negative pregnancy tests. Exclude prior bispecific or CAR‑T, study‑drug allergy/intolerance, live vaccine <4wk, CNS MM, recent/planned major surgery/trauma or not recovered.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 1 randomized, open-label PK comparability of pre‑change vs post‑change teclistamab in relapsed/refractory multiple myeloma. Drug/Type/MOA: Teclistamab (JNJ-64007957) is a subcutaneous, T‑cell–redirecting bispecific monoclonal antibody (IgG4) that binds BCMA (TNFRSF17) on myeloma/plasma cells and CD3 on T cells. By bridging CD3+ T cells to BCMA+ tumor cells, it forms an immune synapse, activates TCR/CD3 signaling, and drives T‑cell cytotoxicity (perforin/granzyme) and cytokine release leading to apoptosis of myeloma cells. Targets (cells/pathways): • BCMA on malignant plasma cells (multiple myeloma). • CD3 on cytotoxic T cells to trigger TCR signaling and effector function. The study tests the same mechanism pre‑ vs post‑manufacturing change to compare pharmacokinetics, efficacy/safety follow standard teclistamab use.