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Active, not recruitingNCT03915184Updated Dec 19, 2023

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

A Phase 1/2 interventional study of zevor-cel in Multiple Myeloma, sponsored by CARsgen Therapeutics Co., Ltd.. Active, not recruiting at 13 sites in 2 countries. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2023-12-19.

Sponsored by CARsgen Therapeutics Co., Ltd. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 1/2
Study type
Interventional
Enrollment
105
Allocation
Not applicable
Ages
18 Years to 79 Years
Sex
All
01

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.

Read the detailed 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.

02

Conditions studied

  • Multiple Myeloma

Keywords

  • CAR-T
  • Carcinoma
  • Carcinoma, Multiple Myeloma
  • CT053
  • zevor-cel
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 105 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

CARsgen Therapeutics Co., Ltd. is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
105 participants (estimated)

Study arms

  • Experimental
    CAR-BCMA T Cells

    Phase 1b will include a dose escalation followed by an expansion cohort to determine the recommended dose for the expansion part. After recommended Phase 2 is determined, patients in Phase 2 will be treated.

    Biological: zevor-cel

Interventions

  • Biologicalzevor-cel

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

    Also known as: CAR-BCMA T Cell Infusion

06

What researchers measure

Primary outcomes

  1. Incidence of Treatment Related adverse events (AEs)

    Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs)

    Time frame: Day 1 - Month 60

  2. Identification of Maximum Tolerated Dose (MTD)

    Incidence of dose-limiting toxicities (DLTs)

    Time frame: Day 1 - Month 60

  3. Objective response rate

    Objective response rate (ORR) per IMWG by IRC read

    Time frame: Day 1 - Month 60

Secondary outcomes

  1. 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

    Time frame: Day 1 - Month 60

  2. 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

    Time frame: Day 1 - Month 60

  3. Evaluate zevor-cel PK profile

    CAR transgene copy number, peak value, AUC, in vivo persistence

    Time frame: Day 1 - Month 60

  4. Evaluate ADA profile

    Percentage of patients with anti-zevor-cel drug antibodies

    Time frame: Day 1 - Month 60

  5. 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

    Time frame: Day 1 - Month 60

  6. Evaluate utilization of hospital resources

    Duration of hospitalization and ICU

    Time frame: Day 1 - Month 60

Other outcomes

  1. BCMA bone marrow expression and soluble BCMA expression in blood

    Myeloma cell BCMA expression and serum soluble BCMA

    Time frame: Day 1 - Month 60

  2. Cytokine profiling

    cytokine levels (such as IL-6, INF, et al)

    Time frame: Day 1 - Month 60

  3. zevor-cel product profiling vs clinical safety and efficacy

    zevor-cel product characteristics

    Time frame: Day 1 - Month 60

07

Study locations

13 sites
  • Mayo Clinic Hospital
    Phoenix, Arizona 85054, United States
  • UCSF
    San Francisco, California 94143, United States
  • Colorado Blood Cancer Institute
    Denver, Colorado 80218, United States
  • Moffitt Cancer Center
    Tampa, Florida 33612, United States
  • Dana Farber Cancer Center
    Boston, Massachusetts 02215, United States
  • Mayo
    Rochester, Minnesota 55905, United States
  • TriStar CMC
    Nashville, Tennessee 37203, United States
  • UT Southwestern Medical Center
    Dallas, Texas 76021, United States
  • MD Anderson
    Houston, Texas 77030, United States
  • Methodist Hosptial
    Houston, Texas 77030, United States
  • Huntsman Cancer Center
    Salt Lake City, Utah 84112, United States
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
  • Princess Margaret Hospital
    Toronto, Ontario MSG 2C4, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03915184
Lead sponsor
CARsgen Therapeutics Co., Ltd.
Responsible party
Sponsor
First posted
Apr 16, 2019
Start date
Sep 25, 2019
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2034 (estimated)
Last update
Dec 19, 2023

Study contacts

Shaji Kumar, MD
principal investigator · Mayo

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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