Clinical Trial to Evaluate Zevor-cel (CT053) in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 2)
a study on Multiple Myeloma
Summary
- Eligibility
- for people ages 18-79 (full criteria)
- Location
- at San Francisco, California and other locations
- Dates
- study startedestimated completion
Description
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.
Official Title
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)
Details
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.
Keywords
Multiple Myeloma, CAR-T, Carcinoma, Carcinoma, Multiple Myeloma, CT053, zevor-cel, Plasma Cell Neoplasms, CAR-BCMA T Cells
Eligibility
You can join if…
Open to people ages 18-79
- 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;
10. Sufficient venous access for leukapheresis collection, and no other contraindications
to leukapheresis;
11. Women of childbearing age must undergo a serum pregnancy test with negative results
before screening, and are willing to use effective and reliable method of contraception for at least 12 months after T cell infusion;
12. Men must be willing to use effective and reliable method of contraception for at least
12 months after T cell infusion.
You CAN'T join if...
- 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;
10. 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;
11. Patients have been administered live attenuated vaccine before leukapheresis or
lymphodepletion;
12. Patients allergic to Flu, Cy, tocilizumab, dimethyl sulfoxide (DMSO) or zevor-cel CAR
BCMA T cell;
13. Patients have clinical significant cardiac conditions that researchers believe that
participating in this clinical trial may endanger the health of the patients;
14. Patients have clinical significant pulmonary conditions; 15. Patients are known to have active autoimmune diseases including but not limited to
psoriasis, rheumatoid arthritis and other needs of long-term immunosuppressive therapy;
16. Patients with second malignancies in addition to MM are not eligible; 17. Patients have central nervous system (CNS) metastases or CNS involvement; 18. Patients have significant neurologic disorders; 19. Patients are unable or unwilling to comply with the requirements of clinical trial; 20. Patients have received major surgery prior to leukapheresis or prior to
lymphodepletion.
Locations
- UCSF
accepting new patients
San Francisco California 94143 United States - Mayo Clinic Hospital
accepting new patients
Phoenix Arizona 85054 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- CARsgen Therapeutics Co., Ltd.
- ID
- NCT03915184
- Phase
- Phase 1/2 Multiple Myeloma Research Study
- Study Type
- Interventional
- Participants
- Expecting 105 study participants
- Last Updated
Frequently Asked Questions
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT03915184.