Autologous Chimeric Antigen Receptor (CAR) T-cells Targeting the Kappa Myeloma Antigen (KM
The study proposed here intends to evaluate the safety and efficacy of escalating doses of autologous PMCC-COE-KMA CAR T-cells administered to patients with relapsed/refractory multiple myeloma that expresses the KMA. The PMCC-COE-KMA CAR T-cells will be produced using LV and administered to patients after lymphodeplet
| Condition(s) | Relapsed/Refractory Multiple Myeloma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | The study proposed here intends to evaluate the safety and efficacy of escalating doses of autologous PMCC-COE-KMA CAR T-cells administered to patients with relapsed/refractory multiple myeloma that expresses the KMA. The PMCC-COE-KMA CAR T-cells will be produced using LV and administered to patients after lymphodepleting conditioning chemotherapy. Considering the poor prognosis of myeloma patients who have relapsed after ≥ 2 lines of therapy, combined with evidence of PMCC-COE-KMA CAR T-cell specificity, as well as the efficacy and manageable toxicity of PMCC-COE-KMA, investigators believe the potential benefits outweigh the risks of this trial. |
| Who can participate | Inclusion Criteria: 1. Patient has provided written informed consent using the KOALA Patient Information and Consent Form (PICF) 2. Age ≥ 18 years on the day of signing informed consent form 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2 (Appendix 2) 4. Life expectancy of ≥ 3 months, as assessed by the Investigator 5. A diagnosis of kappa-restricted RR MM with evidence of KMA on the surface of bone marrow plasma cells using flow cytometry analysis as determined by investigator 6. Have received at least 2 prior lines of therapy including a proteosome inhibitor and an immunomodulatory imide drug with evidence of disease progression as per IMWG criteria (Appendix 1) after the most recent line of therapy Note 1: induction with or without haematopoietic stem cel |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Peter MacCallum Cancer Centre, Australia |
| Locations | Melbourne, Victoria, Australia |
| Start date | 2026-05 |
| NCT ID | NCT07541391 |
| Official listing | https://clinicaltrials.gov/study/NCT07541391 |