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.
Patient has provided written informed consent using the KOALA Patient Information and Consent Form (PICF)
Age ≥ 18 years on the day of signing informed consent form
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2 (Appendix 2)
Life expectancy of ≥ 3 months, as assessed by the Investigator
A diagnosis of lambda-restricted MM
Plasma cell leukaemia at the time of Screening (> 5% circulating plasma cells by standard differential), Waldenström's macroglobulinaemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis
Known active, or prior history of, central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM
Major surgery within 4 weeks prior to registration
Peter MacCallum Cancer Centre, Australia
Lead sponsor
HaemalogiX Ltd
Collaborator