Moffitt Cancer Center: Clinical Trial 20253

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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.