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)
Single group
Chimeric Antigen Receptor T Cells (CAR-T)
Biological/VaccineThis product is a CAR T-cell therapy utilizing the participant's own autologous T-lymphocytes, which are collected via apheresis, processed in a laboratory setting, and subsequently reinfused intravenously through a peripheral vein at a rate of 2-5 mL/min. Participants will undergo cell collection via apheresis for product preparation, followed by lymphodepleting chemotherapy. This process includes pre-chemotherapy and pre-infusion assessments prior to the administration of CART-BCMA cells.
The safety of CART-BCMA in patients with relapsed or refractory multiple myeloma.
Number and percentage of participants experiencing treatment-emergent adverse events (AEs) and serious adverse events (SAEs) after CART-BCMA cell infusion. AEs will be graded according to CTCAE version 5.0
Incidence of Dose-Limiting Toxicities (DLTs)
Number and percentage of participants experiencing dose-limiting toxicities (DLTs) during the DLT evaluation period following CART-BCMA cell infusion. DLTs will be defined according to protocol-specified criteria and graded using Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
The overall response rate (ORR, at least PR or better) per IMWG 2016 Criteria
Percentage of participants achieving at least Partial Response (PR) or better (PR, VGPR, CR, or sCR) as assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria.
Complete Response (CR) or Stringent Complete Response (sCR) Rate per IMWG 2016 Criteria
Percentage of participants achieving Complete Response (CR) or Stringent Complete Response (sCR) according to IMWG 2016 criteria.
Very Good Partial Response (VGPR) or Better Rate per IMWG 2016 Criteria
Percentage of participants achieving VGPR or better (VGPR, CR, or sCR) according to IMWG 2016 criteria.
Time to First Documented Response (≥PR) per IMWG 2016 Criteria
Time from CART-BCMA cell infusion to first documented response of PR or better according to IMWG 2016 criteria.
Maximum Observed CAR-T Cell Expansion (Cmax)
Maximum observed concentration of CART-BCMA cells and/or CAR transgene copy number in peripheral blood following infusion. Cellular kinetics will be assessed using quantitative PCR and/or flow cytometry.
Time to Maximum Observed CAR-T Cell Expansion (Tmax)
Time from CART-BCMA cell infusion to maximum observed concentration (Cmax) of CART-BCMA cells or CAR transgene copy number.
Area Under the Concentration-Time Curve of CAR-T Cells from Day 0 to Day 28 (AUC0-28d)
Area under the concentration-time curve of CART-BCMA cells or CAR transgene copy number in peripheral blood from Day 0 to Day 28 after infusion.
Area Under the Concentration-Time Curve of CAR-T Cells from Day 0 to Day 90 (AUC0-90d)
Area under the concentration-time curve of CART-BCMA cells or CAR transgene copy number in peripheral blood from Day 0 to Day 90 after infusion.Area under the concentration-time curve of CART-BCMA cells or CAR transgene copy number in peripheral blood from Day 0 to Day 90 after infusion.
Click on the lead sponsor to view all of their trials.
Chulalongkorn University
Lead sponsor
King Chulalongkorn Memorial Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
