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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03915184
Other study ID # CT053-MM-02 (LUMMICAR STUDY 2)
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date September 25, 2019
Est. completion date December 31, 2034

Study information

Verified date December 2023
Source CARsgen Therapeutics Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 105
Est. completion date December 31, 2034
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 79 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
zevor-cel
A single autologous chimeric antigen receptor-B-cell maturation antigen (CAR-BCMA T cell) infusion

Locations

Country Name City State
Canada Princess Margaret Hospital Toronto Ontario
United States Dana Farber Cancer Center Boston Massachusetts
United States UT Southwestern Medical Center Dallas Texas
United States Colorado Blood Cancer Institute Denver Colorado
United States MD Anderson Houston Texas
United States Methodist Hosptial Houston Texas
United States Medical College of Wisconsin Milwaukee Wisconsin
United States TriStar CMC Nashville Tennessee
United States Mayo Clinic Hospital Phoenix Arizona
United States Mayo Rochester Minnesota
United States Huntsman Cancer Center Salt Lake City Utah
United States UCSF San Francisco California
United States Moffitt Cancer Center Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
CARsgen Therapeutics Co., Ltd.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other BCMA bone marrow expression and soluble BCMA expression in blood Myeloma cell BCMA expression and serum soluble BCMA Day 1 - Month 60
Other Cytokine profiling cytokine levels (such as IL-6, INF, et al) Day 1 - Month 60
Other zevor-cel product profiling vs clinical safety and efficacy zevor-cel product characteristics Day 1 - Month 60
Primary Incidence of Treatment Related adverse events (AEs) Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs) Day 1 - Month 60
Primary Identification of Maximum Tolerated Dose (MTD) Incidence of dose-limiting toxicities (DLTs) Day 1 - Month 60
Primary Objective response rate Objective response rate (ORR) per IMWG by IRC read Day 1 - Month 60
Secondary Evaluate additional clinical efficacy outcomes with zevor-cel treatment in patients with rrMM Disease-specific response criteria including, but not limited to: complete response (CR), MRD, very good partial response (VGPR), and partial response (PR) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma, Time to Response, Time to Progression, Progression Free Survival, best response and Overall Survival Day 1 - Month 60
Secondary Determine the efficacy of zevor-cel treatment in patients with rrMM, by investigator assessment ORR, DOR, FPS, OS, MRD, time to response, time to progression, best tumor response Day 1 - Month 60
Secondary Evaluate zevor-cel PK profile CAR transgene copy number, peak value, AUC, in vivo persistence Day 1 - Month 60
Secondary Evaluate ADA profile Percentage of patients with anti-zevor-cel drug antibodies Day 1 - Month 60
Secondary Evaluate HRQoL in patients with rrMM from baseline up to study completion Change from baseline in HRQoL as measured by EORTC QLQ-C30 and QLQ-MY20 Day 1 - Month 60
Secondary Evaluate utilization of hospital resources Duration of hospitalization and ICU Day 1 - Month 60
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