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Clinical Trial to Evaluate 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 : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
CARsgen Therapeutics Co., Ltd.

Tracking Information
First Submitted Date  ICMJE April 3, 2019
First Posted Date  ICMJE April 16, 2019
Last Update Posted Date February 25, 2021
Actual Study Start Date  ICMJE September 25, 2019
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
  • 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)
  • Identification of Maximum Tolerated Dose (MTD) [ Time Frame: day 1 - month 60 ]
    Incidence of dose-limiting toxicities (DLTs)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
Evaluate the clinical efficacy of CT053 in patients with rrMM after a single administration of CT053 [ Time Frame: day 1 - month 60 ]
Disease-specific response criteria including, but not limited to: complete response (CR), very good partial response (VGPR), and partial response (PR) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma, Progression Free Survival and Overall Survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Evaluate CT053 in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 2)
Official Title  ICMJE 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)
Brief Summary A phase 1b, open label, multi-center, Clinical Study of Chimeric Antigen Receptor T Cells targeting BCMA in patients with relapsed and or refractory multiple myeloma.
Detailed Description

This is an open label, multi-center, phase 1b clinical trial to evaluate the safety and efficacy of autologous chimeric antigen receptor-B-cell maturation antigen (CAR-BCMA T cell; CT053) in patients with relapsed and or refractory multiple myeloma.

Part A of the study will be Dose Escalation followed by Part B, an expansion cohort. Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (CT053). Following manufacture of the drug product, subjects will receive lymphodepletion prior to CT053 infusion. All subjects who complete the study, as well as those who withdraw from the study after receiving CT053 for reasons other than death or meeting the early termination criteria, will be asked to continue to undergo long-term follow-up in a companion study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE Biological: CT053
A single autologous chimeric antigen receptor-B-cell maturation antigen (CAR-BCMA T cell) infusion
Other Name: CAR-BCMA T Cell Infusion
Study Arms  ICMJE Experimental: CAR-BCMA T Cells
Phase 1b will include two parts, a dose escalation part to determine the recommended dose for the expansion part. During expansion patients will be treated with the recommended dose determined in the expansion part.
Intervention: Biological: CT053
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 12, 2019)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2023
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 daratumumab.
  5. The patients should have measurable disease per IMWG definition.
  6. Estimated life expectancy > 12 weeks;
  7. ECOG performance score 0-1;
  8. Patients should have reasonable CBC counts, renal and hepatic functions;
  9. Sufficient venous access for leukapheresis collection, and no other contraindications to leukapheresis;
  10. 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 6 months after T cell infusion;
  11. Men must be willing to use effective and reliable method of contraception for at least 6 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 less than 12 weeks 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 CT053 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hong Ma, MD CentralNumber clinicalUS@carsgen.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03915184
Other Study ID Numbers  ICMJE CT053-MM-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CARsgen Therapeutics Co., Ltd.
Study Sponsor  ICMJE CARsgen Therapeutics Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shaji Kumar, MD Mayo
PRS Account CARsgen Therapeutics Co., Ltd.
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP