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Clinical Trial 20253

Cancer Type: Multiple Myeloma
Interventions:

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Jason Brayer

Call 813-745-6100
or 1-800-679-0775
Overview

Study 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

Summary

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.

Objective

Primary: -Evaluate the safety and tolerability of CAR-BCMA T cell (CT053) therapy in patients with rrMM -Identify the MTD and explore a RP2D of CT053 therapy in patients with rrMM Secondary: -Evaluate clinical efficacy outcomes with CAR-BCMA T cell (CT053) therapy in patients with rrMM Exploratory: -Evaluate Health-related Quality-of-Life (HRQoL) therapy in patients with rrMM from baseline up to study completion -Evaluate CT053 cell's pharmacokinetics (PK) and biodistribution

Inclusion Criteria

  • 18 years of age or older
  • Received sufficient prior lines of myeloma therapy
  • Received treatment with at least one proteasome inhibitor, one IMiD and daratumumab
  • The participants should have measurable disease per IMWG definition.
  • Estimated life expectancy > 12 weeks
  • ECOG performance score 0-1
  • Participants should have reasonable CBC counts, renal and hepatic functions
  • Sufficient venous access for leukapheresis collection, and no other contraindications to leukapheresis
  • 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
  • Men must be willing to use effective and reliable method of contraception for at least 6 months after T cell infusion.

  • Exclusion Criteria

  • Pregnant or lactating women
  • HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infection
  • Any uncontrolled active infection
  • Adverse Events from previous treatment that have not recovered
  • Participants who have had anti-BCMA therapy
  • Participants who have graft versus host disease (GvHD)
  • Participants have received stem cell transplantation less than 12 weeks before leukapheresis
  • Participants have received any anti-cancer treatment before leukapheresis
  • Participants have received steroids before leukapheresis or lymphodepletion
  • Participants 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
  • Participants have been administered live attenuated vaccine before leukapheresis or lymphodepletion
  • Participants allergic to Flu, Cy, tocilizumab, dimethyl sulfoxide (DMSO) or CT053 CAR BCMA T cell
  • Participants have clinical significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the participants
  • Participants have clinical significant pulmonary conditions
  • Participants are known to have active autoimmune diseases including but not limited to psoriasis, rheumatoid arthritis and other needs of long-term immunosuppressive therapy
  • Participants with second malignancies in addition to MM are not eligible
  • Participants have central nervous system (CNS) metastases or CNS involvement
  • Participants have significant neurologic disorders
  • Participants are unable or unwilling to comply with the requirements of clinical trial
  • Participants have received major surgery prior to leukapheresis or prior to lymphodepletion.