Open label, multi-center, phase 1b/2 clinical trial to evaluate the safety and efficacy of autologous CAR-BCMA T cells (CT053) in subjects with relapsed and/or refractory multiple myeloma

NOT ENROLLING
Protocol # :
19-453
Conditions
Multiple Myeloma
Phase
I/II
Disease Sites
Multiple Myeloma
Principal Investigator
Laubach, Jacob, Peter
Site Research Nurses
Coleman, Kimberly, C.
Dalton, Virginia, M.
Flaherty, Tina
Hogan, Sarah
Noonan, Kimberly Rogers
O'Brien, Alexandra
Regan, Eileen

Trial Description

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 Requirements

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.

19-453