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

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ClinicalTrials.gov Identifier: NCT03915184
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 28, 2022
Sponsor:
Information provided by (Responsible Party):
CARsgen Therapeutics Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: zevor-cel Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Multi-center, Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of Autologous CAR BCMA T Cells (CT053) in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 2)
Actual Study Start Date : September 25, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2034

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
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
A single autologous chimeric antigen receptor-B-cell maturation antigen (CAR-BCMA T cell) infusion
Other Name: CAR-BCMA T Cell Infusion




Primary Outcome Measures :
  1. Incidence of Treatment Related adverse events (AEs) [ Time Frame: Day 1 - Month 60 ]
    Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs)

  2. Identification of Maximum Tolerated Dose (MTD) [ Time Frame: Day 1 - Month 60 ]
    Incidence of dose-limiting toxicities (DLTs)

  3. Objective response rate [ Time Frame: Day 1 - Month 60 ]
    Objective response rate (ORR) per IMWG by IRC read


Secondary Outcome Measures :
  1. Evaluate additional clinical efficacy outcomes with zevor-cel treatment in patients with rrMM [ Time Frame: Day 1 - Month 60 ]
    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

  2. Determine the efficacy of zevor-cel treatment in patients with rrMM, by investigator assessment [ Time Frame: Day 1 - Month 60 ]
    ORR, DOR, FPS, OS, MRD, time to response, time to progression, best tumor response

  3. Evaluate zevor-cel PK profile [ Time Frame: Day 1 - Month 60 ]
    CAR transgene copy number, peak value, AUC, in vivo persistence

  4. Evaluate ADA profile [ Time Frame: Day 1 - Month 60 ]
    Percentage of patients with anti-zevor-cel drug antibodies

  5. Evaluate HRQoL in patients with rrMM from baseline up to study completion [ Time Frame: Day 1 - Month 60 ]
    Change from baseline in HRQoL as measured by EORTC QLQ-C30 and QLQ-MY20

  6. Evaluate utilization of hospital resources [ Time Frame: Day 1 - Month 60 ]
    Duration of hospitalization and ICU


Other Outcome Measures:
  1. BCMA bone marrow expression and soluble BCMA expression in blood [ Time Frame: Day 1 - Month 60 ]
    Myeloma cell BCMA expression and serum soluble BCMA

  2. Cytokine profiling [ Time Frame: Day 1 - Month 60 ]
    cytokine levels (such as IL-6, INF, et al)

  3. zevor-cel product profiling vs clinical safety and efficacy [ Time Frame: Day 1 - Month 60 ]
    zevor-cel product characteristics



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915184


Contacts
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Contact: Hong Ma, MD CentralNumber clinicalUS@carsgen.com

Locations
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United States, Arizona
Mayo Clinic Hospital Recruiting
Phoenix, Arizona, United States, 85054
United States, California
UCSF Not yet recruiting
San Francisco, California, United States, 94143
United States, Colorado
Colorado Blood Cancer Institute Recruiting
Denver, Colorado, United States, 80218
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
United States, Massachusetts
Dana Farber Cancer Center Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Recruiting
Rochester, Minnesota, United States, 55905
United States, New York
Weill Cornell Medical Center Not yet recruiting
New York, New York, United States, 10065
United States, Tennessee
TriStar CMC Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 76021
MD Anderson Recruiting
Houston, Texas, United States, 77030
Methodist Hosptial Not yet recruiting
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Center Recruiting
Salt Lake City, Utah, United States, 84112
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, MSG 2C4
Sponsors and Collaborators
CARsgen Therapeutics Co., Ltd.
Investigators
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Principal Investigator: Shaji Kumar, MD Mayo
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Responsible Party: CARsgen Therapeutics Co., Ltd.
ClinicalTrials.gov Identifier: NCT03915184    
Other Study ID Numbers: CT053-MM-02 (LUMMICAR STUDY 2)
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 28, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by CARsgen Therapeutics Co., Ltd.:
CAR-T
Carcinoma
Carcinoma, Multiple Myeloma
CT053
zevor-cel
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases