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

Korábbi kezelés

• AEs from previous treatment that have not recovered;
• Patients who have had anti-BCMA therapy;
• 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 been administered live attenuated vaccine before leukapheresis or lymphodepletion;
• Patients have received major surgery prior to leukapheresis or prior to lymphodepletion.

Más betegség

• HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infection;
• Any uncontrolled active infection;
• Patients who have graft versus host disease (GvHD);
• 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 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 significant neurologic disorders;

Egyéb

• Pregnant or lactating women;
• Patients have central nervous system (CNS) metastases or CNS involvement;
• Patients are unable or unwilling to comply with the requirements of clinical trial;

• 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.