CART-BCMA Cells for Multiple Myeloma

Overview

Open-label, single-center, pilot study to assess the safety and feasibility of infusion of autologous T cells expressing BCMA (B-cell maturation antigen)-specific chimeric antigen receptors with tandem TCR and 4-1BB costimulatory domains (referred to as CART-BCMA ) in adult patients with multiple myeloma (MM). CART-BCMA cells will be given as a split dose intravenous infusion over 3 days. The duration of active intervention and monitoring is approximately 2 years.
SparkCures ID 752
Trial Phase Phase 0
Enrollment 30 Patients
Treatments
  • T Cells
Trial Sponsors
  • Abramson Cancer Center
NCT Identifier

NCT02546167

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:

  • Subjects must have a confirmed prior diagnosis of active MM as defined by the IMWG criteria 20.
  • Subjects must have relapsed or refractory disease after either one of the following:
    • At least 3 prior regimens, which must have contained an alkylating agent, proteasome inhibitor, and immunomodulatory agent (IMiD). OR
    • At least 2 prior regimens if "double-refractory" to a proteasome inhibitor and IMiD, defined as progression on or within 60 days of treatment with these agents.
    • Note: induction therapy, stem cell transplant, and maintenance therapy, if given sequentially without intervening progression, should be considered as 1 "regimen".
  • Subjects must have signed written, informed consent.
  • Subjects must be ≥ 18 years of age.
  • Subjects must be at least 90 days since autologous stem cell transplant, if performed.
  • Subjects must have adequate vital organ function:
    1. Serum creatinine ≤ 2.5 or estimated creatinine clearance ≥30 ml/min and not dialysis-dependent.
    2. Absolute neutrophil count ≥1000/μl and platelet count ≥50,000/μl (≥30,000/μl if bone marrow plasma cells are ≥50% of cellularity).
    3. SGOT ≤ 3x the upper limit of normal and total bilirubin ≤ 2.0 mg/dl (except for patients in whom hyperbilirubinemia is attributed to Gilbert's syndrome).
    4. Left ventricular ejection fraction (LVEF) ≥ 45%. LVEF assessment must have been performed within 8 weeks of enrollment.
    5. Toxicities from prior therapies, with the exception of peripheral neuropathy attributable to bortezomib, must have recovered to grade ≤ 2 according to the CTC 4.0 criteria or to the subject's prior baseline.
  • Subjects must have an ECOG performance status of 0-2.

Exclusion Criteria:

  • Be pregnant or lactating.
  • Have inadequate venous access for or contraindications to leukapheresis.
  • Have any active and uncontrolled infection.
  • Have active hepatitis B, hepatitis C, or HIV infection.
  • Any uncontrolled medical or psychiatric disorder that would preclude participation as outlined.
  • Have NYHA Class III or IV heart failure, unstable angina, or a history of recent (within 6 months) myocardial infarction or sustained (>30 seconds) ventricular tachyarrhythmias.
  • Have undergone allogeneic stem cell transplantation.
  • Have received prior gene therapy or gene-modified cellular immunotherapy. Subject may have received, however, non-gene-modified autologous T-cells in association with an anti-myeloma

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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