Clinical Trial to Evaluate Zevor-cel (CT053) in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 2)


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.

SparkCures ID 1032
Trial Phase Phase 1/2
Enrollment 105 Patients
Trial Sponsors
  • CARsgen Therapeutics
NCT Identifier


Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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;
  • 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;
  • Men must be willing to use effective and reliable method of contraception for at least 12 months after T cell infusion.

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;
  • Patients have been administered live attenuated vaccine before leukapheresis or lymphodepletion;
  • Patients allergic to Flu, Cy, tocilizumab, dimethyl sulfoxide (DMSO) or zevor-cel CAR BCMA T cell;
  • Patients have clinical significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the patients;
  • Patients have clinical significant pulmonary conditions;
  • Patients are known to have active autoimmune diseases including but not limited to psoriasis, rheumatoid arthritis and other needs of long-term immunosuppressive therapy;
  • Patients with second malignancies in addition to MM are not eligible;
  • Patients have central nervous system (CNS) metastases or CNS involvement;
  • Patients have significant neurologic disorders;
  • Patients are unable or unwilling to comply with the requirements of clinical trial;
  • Patients have received major surgery prior to leukapheresis or prior to lymphodepletion.


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