zevor-cel: A single autologous chimeric antigen receptor-B-cell maturation antigen (CAR-BCMA T cell) infusion
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
79 Years
Healthy volunteers
No
Inclusion Criteria:
1. Voluntarily signed consent;
2. Age of ≥ 18 and \< 80 years;
3. Received sufficient prior lines of myeloma therapy;
4. Received treatment with at least one proteasome inhibitor, one IMiD and CD38 anti body.
5. The patient must be refractory to the last line of therapy.
6. The patients should have measurable disease per IMWG definition.
7. Estimated life expectancy \> 12 weeks;
8. ECOG performance score 0-1;
9. 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.
Exclusion Criteria:
1. Pregnant or lactating women;
2. HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infection;
3. Any uncontrolled active infection;
4. AEs from previous treatment that have not recovered;
5. Patients who have had anti-BCMA therapy;
6. Patients who have graft versus host disease (GvHD);
7. Patients have received stem cell transplantation one year before leukapheresis;
8. Patients have received any anti-cancer treatment before leukapheresis;
9. 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.
Primary outcome measure(s)
Incidence of Treatment Related adverse events (AEs) — Day 1 - Month 60 Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs)
Identification of Maximum Tolerated Dose (MTD) — Day 1 - Month 60 Incidence of dose-limiting toxicities (DLTs)
Objective response rate — Day 1 - Month 60 Objective response rate (ORR) per IMWG by IRC read
Trial sites (13)
Facility
City
Region
Status
Mayo Clinic Hospital
Phoenix
Arizona
UCSF
San Francisco
California
Colorado Blood Cancer Institute
Denver
Colorado
Moffitt Cancer Center
Tampa
Florida
Dana Farber Cancer Center
Boston
Massachusetts
Mayo
Rochester
Minnesota
TriStar CMC
Nashville
Tennessee
UT Southwestern Medical Center
Dallas
Texas
MD Anderson
Houston
Texas
Methodist Hosptial
Houston
Texas
Huntsman Cancer Center
Salt Lake City
Utah
Medical College of Wisconsin
Milwaukee
Wisconsin
Princess Margaret Hospital
Toronto
Ontario
More CARsgen Therapeutics Co., Ltd. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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