A Phase 1b clinical trial to evaluate the safety and efficacy of BCMA-targeted CAR T-cell therapy in Thai patients with relapsed or refractory multiple myeloma.
Age above 18 years old (inclusive), regardless of gender.
Patients with multiple myeloma who have received at least three lines of treatment for multiple myeloma and have failed at least after treatment with proteasome inhibitors and immunomodulators; At least one complete cycle of each line of therapy, unless the best response to that therapy was documented as progressive disease (PD) (according to the 2016 published IMWG criteria for efficacy evaluation, Appendix 4); Patients must have PD records during or within 12 months after the last treatment or no response (no MR or better response) within 60 days after the last treatment.
Serum M protein ≥ 1 g/dL (≥ 10 g/L)
Urinary M-protein level ≥ 200 mg/24 hours
Subjects with a known history of allergy, hypersensitivity, intolerance, or contraindication to any component of CART-BCMA or drugs that may be used in the study (including fludarabine, cyclophosphamide, tocilizumab); or subjects allergic to beta-lactam antibiotics; or subjects with a history of severe allergic reactions.
Subjects who have previously received any CAR-T therapy or BCMA-targeted therapy.
Small-molecule targeted therapy within 4 weeks or five half-lives, whichever was longer
Macromolecular drug therapy within 4 weeks or 2 half-lives (whichever is longer)
Chulalongkorn University
Lead sponsor
King Chulalongkorn Memorial Hospital
Collaborator