Open Label, Multi-center, Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of Autologous CAR BCMA T Cells (CT053) in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 2)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Multiple Myeloma
- Sponsor
- CARsgen Therapeutics Co., Ltd.
- Enrollment
- 105
- Locations
- 13
- Primary Endpoint
- Objective response rate
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
A phase 1b/2, open label, multi-center, Clinical Study of Chimeric Antigen Receptor T Cells targeting BCMA in patients with relapsed and or refractory multiple myeloma.
Detailed Description
This is an open label, multi-center, phase 1b/2 clinical trial to evaluate the safety and efficacy of autologous chimeric antigen receptor-B-cell maturation antigen (CAR-BCMA T cell; zevor-cel/CT053) in patients with relapsed and or refractory multiple myeloma. Phase 1b of the study will be dose escalation followed by an expansion cohort. After recommended Phase 2 dose is identified in Phase 1b, the enrollment of Phase 2 will start. Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (zevor-cel). Following manufacture of the drug product, subjects will receive lymphodepletion prior to zevor-cel infusion. All subjects who complete the study, as well as those who withdraw from the study after receiving zevor-cel for reasons other than death or meeting the early termination criteria, will be asked to continue to undergo a 15-year long-term follow-up study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Voluntarily signed consent;
- •Age of ≥ 18 and \< 80 years;
- •Received sufficient prior lines of myeloma therapy;
- •Received treatment with at least one proteasome inhibitor, one IMiD and CD38 anti body.
- •The patient must be refractory to the last line of therapy.
- •The patients should have measurable disease per IMWG definition.
- •Estimated life expectancy \> 12 weeks;
- •ECOG performance score 0-1;
- •Patients should have reasonable CBC counts, renal and hepatic functions;
- •Sufficient venous access for leukapheresis collection, and no other contraindications to leukapheresis;
Exclusion Criteria
- •Pregnant or lactating women;
- •HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infection;
- •Any uncontrolled active infection;
- •AEs from previous treatment that have not recovered;
- •Patients who have had anti-BCMA therapy;
- •Patients who have graft versus host disease (GvHD);
- •Patients have received stem cell transplantation one year before leukapheresis;
- •Patients have received any anti-cancer treatment before leukapheresis;
- •Patients have received steroids before leukapheresis or lymphodepletion;
- •Patients have plasma cell leukemia, Waldenström macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome or clinically significant symptomatic immunoglobulin light chain (AL) amyloidosis with evidence of end-organ damage;
Outcomes
Primary Outcomes
Objective response rate
Time Frame: Day 1 - Month 60
Objective response rate (ORR) per IMWG by IRC read
Incidence of Treatment Related adverse events (AEs)
Time Frame: Day 1 - Month 60
Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs)
Identification of Maximum Tolerated Dose (MTD)
Time Frame: Day 1 - Month 60
Incidence of dose-limiting toxicities (DLTs)
Secondary Outcomes
- Evaluate zevor-cel PK profile(Day 1 - Month 60)
- Evaluate HRQoL in patients with rrMM from baseline up to study completion(Day 1 - Month 60)
- Evaluate utilization of hospital resources(Day 1 - Month 60)
- Evaluate additional clinical efficacy outcomes with zevor-cel treatment in patients with rrMM(Day 1 - Month 60)
- Determine the efficacy of zevor-cel treatment in patients with rrMM, by investigator assessment(Day 1 - Month 60)
- Evaluate ADA profile(Day 1 - Month 60)