Clinical Trial 20253

• 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

• Treatments

  Therapies:

  Cell Therapy; Chemotherapy (NOS)

  Medications:

  CT053 (); Not Applicable (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

• Inclusion Criteria

  Inclusion Criteria:
  • Between 18 and 80 years of age
  • Must have received at least 4 prior lines of therapy MM.
  • Must be exposed to at least one proteasome inhibitor, at least one IMiD, and at least one CD38-targeting antibody.
  • Must be refractory to the last line of therapy (progression on or within 60 days of discontinuing treatment).
  • Measurable disease based on at least one of the parameters per protocol.
  • Estimated life expectancy over 12 weeks.
  • ECOG performance score 0-1.
  • Should have reasonable CBC counts, renal and hepatic functions.
  • Sufficient venous access for leukapheresis collection, and no other contraindications to leukapheresis.
  • Women of childbearing potential (WOCBP) must undergo a serum pregnancy test with negative results at screening and lymphodepletion, and must be willing to use effective and reliable contraception for at least 12 months after T-cell infusion.
  • Men must be willing to use effective and reliable contraception for at least 12 months after T-cell infusion.

• Exclusion Criteria

  • Pregnant or lactating women.
  • Patients with HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV)infection. History of treated hepatitis B or C is permitted if the viral load is undetectable per qPCR and or nucleic acid testing.
  • Patients with any uncontrolled active infection. Note: For patients with active SARS-CoV-2 (COVID-19) infection, at the treating physician’s discretion, the patient can be considered for study inclusion at a later date when the COVID-19 test returns a negative result.
  • Patients with AEs from previous treatment that have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 1 or less, excluding hair loss, neuropathy and other events that the treating physician can determine are unlikely to lead to cumulative toxicity from lymphodepletion or CAR T-cell treatment.
  • Patients who have had any of the following: a. Previous anti-BCMA therapy (antibody-drug conjugate) (a) without response to treatment (≤PR), and (b) within one year after last anti-BCMA treatment. b. Previous anti-BCMA CAR-T therapy or bi-specific T cell engager (with or without response to the treatment). c. Any other type of investigational cellular therapy within one year (such as CART, TCR, NK, NKT, etc.).
  • Patients who have active acute graft versus host disease (GvHD) or chronic GvHD, or patients who had previous Grade 2 or higher GvHD.
  • Patients who have received any of the following: a. Autologous stem cell transplantation within one year. b. Allogeneic stem cell transplantation within two years. 8. Patients who have received any anticancer treatment 14 days before leukapheresis or lymphodepletion. If the field of radiation covers ≤ 5% of the bone marrow, the subjects are eligible to participate in the study regardless of the radiotherapy end date. Note: Any anticancer or bridging treatment encroaching into the 14-day washout period may be allowable if discussed with and approved by the study medical monitor.
  • Patients who have received radiation in which the field covers > 5% of the bone marrow 30 days before leukapheresis or 14 days before lymphodepletion. Patients who have received any anticancer treatment other than radiation 14 days before leukapheresis or lymphodepletion. If the field of radiation covers ≤ 5% of the bone marrow, the subjects are eligible to participate in the study regardless of the radiotherapy end date.
  • Patients who have received therapeutic systemic doses of corticosteroids within 14 days before leukapheresis or 72 hours prior to lymphodepletion. Physiologic replacement, topical, intranasal, and inhaled steroids are permitted
  • Patients who 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.
  • Patients who have received a live attenuated vaccine 4 weeks before leukapheresis or lymphodepletion. Note: The approved COVID-19 vaccines in the US (Pfizer, Moderna and J&J or equivalent) are not live attenuated vaccines. It is recommended that patients wait at least 3 days after COVID-19 vaccination to initiate leukapheresis or lymphodepletion.
  • Patients allergic to Flu, Cy, tocilizumab, or dimethyl sulfoxide (DMSO).
  • Patients who have any of the cardiac conditions listed in protocol.
  • Patients who have one of the pulmonary conditions listed in the protocol
  • Patients known to have active autoimmune diseases including but not limited to psoriasis, rheumatoid arthritis and other needs of long-term immunosuppressive therapy.
  • Patients with second malignancies in addition to MM are not eligible if the second malignancy has required treatment within the past 3 years or is not in complete remission. There are two e

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