Clinical Trials /

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

NCT03915184

Description:

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.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Clinical Trial to Evaluate CT053 in Patients With Relapsed and/or Refractory Multiple Myeloma
  • Official Title: Open Label, Multi-center, Phase 1b Clinical Trial to Evaluate the Safety and Efficacy of Autologous CAR BCMA T Cells (CT053) in Patients With Relapsed and/or Refractory Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: CT053-MM-02
  • NCT ID: NCT03915184

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
CT053CAR-BCMA T Cell InfusionCAR-BCMA T Cells

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
CAR-BCMA T CellsExperimentalPhase 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.
  • CT053

Eligibility Criteria

        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.
      
Maximum Eligible Age:78 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of Treatment Related adverse events (AEs)
Time Frame:day 1 - month 60
Safety Issue:
Description:Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs)

Secondary Outcome Measures

Measure:Evaluate the clinical efficacy of CT053 in patients with rrMM after a single administration of CT053
Time Frame:day 1 - month 60
Safety Issue:
Description: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

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Carsgen Therapeutics, Ltd.

Trial Keywords

  • CAR-T
  • Carcinoma
  • Carcinoma, Multiple Myeloma

Last Updated

November 22, 2019