Clinical Trial to Evaluate CT053 in Patients With Relapsed and/or Refractory Multiple Myeloma

Overview

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.

SparkCures ID 1032
Trial Phase Phase 1
Enrollment 70 Patients
Treatments
Tags
Trial Sponsors
  • CARsgen Therapeutics
NCT Identifier

NCT03915184

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  1. Voluntarily signed consent;
  2. Age of ≥ 18;
  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.

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

Arizona
Florida
Massachusetts
Michigan
Minnesota
Mayo Clinic (Rochester)

Rochester, MN

Texas

Published Results

CARsgen Announces Investigational CAR-T Therapy CT053 Granted PRIME Eligibility by the European Medicines Agency

September 23, 2019

CARsgen Therapeutics Inc., a clinical-stage biopharmaceutical company today announced the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) eligibility to its investigational CAR-T cell therapy fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cells (ct053) for the treatment of relapsed or refractory multiple myeloma.

PRIME eligibility was based on clinical data from an ongoing CT053 BCMA CAR-T phase 1 study in China. The results from the trial were presented at an oral presentation on September 14, 2019 in Boston at the 17th International Myeloma Workshop. As of June 30, 2019, 21 out of 24 myeloma patients (87.5%) who received a median of 4.5 prior lines of myeloma therapy showed objective response. 19 out of 24 patients (79.2%) achieved complete response. There was no grade 3 or higher cytokine release syndrome. The duration of response data will be reported at a future date.

Resources

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