Study of Matched Unrelated Donor T Cell Infusion for Adults With Recurrent or Minimal Residual Disease Hematologic Malignancies After Allogeneic Transplant

Overview

This is a Phase I, multicenter, open-label, non-randomized study of matched unrelated donor BPX-501 T cell infusion in adult subjects with hematological malignancies presenting with recurrent disease minimal residual disease (MRD) post-allogeneic transplant.

SparkCures ID 815
Trial Phase Phase 1
Enrollment 24 Patients
Treatments
Trial Sponsors
  • Bellicum Pharmaceuticals
NCT Identifier

NCT02786485

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 aged ≥ 18 yrs and ≤ 65 yrs;
  • Clinical diagnosis of one of the following hematological malignancies:
    • Leukemia
    • Myelodysplastic Syndromes
    • Lymphomas
    • Multiple Myeloma
    • Other high-risk hematological malignancy eligible for stem cell transplantation per institutional standard;
  • Recurrent disease that presents ≥100 days after, or minimal residual disease (MRD) that presents ≥ 30 days following a hematopoietic stem cell transplant (HSCT) using a matched unrelated donor located through the National Marrow Donor Program (NMDP);
  • Life expectancy >10 weeks;
  • Signed donor and patient/guardian informed consent;
  • A 8/8 genotypic identical match as determined by high resolution typing for the following genetic loci: human leukocyte antigen (HLA)-A, HLA-B, HLA-C and HLA-DRB1;
  • Performance status: Karnofsky score > 50%;
  • Subjects with adequate organ function as measured by:
    • Bone marrow:
      • > 25% donor T-cell chimerism post-transplant
      • Absolute neutrophil count (ANC) >1 x 109/L
    • Cardiac: left ventricular ejection fraction (LVEF) at rest ≥ 45%
    • Pulmonary: forced expiratory volume (FEV) 1, forced vital capacity (FVC), diffusion capacity of lunch for carbon monoxide (DLCO) ≥ 50% predicted (corrected for hemoglobin)
    • Hepatic: direct bilirubin ≤ 3x upper limit of normal (ULN), or aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 5x ULN
    • Renal: creatinine ≤ 2x of ULN for age.

Exclusion Criteria:

  • ≥ Grade II acute GVHD or chronic extensive GVHD due to a previous allograft at the time of screening;
  • Active central nervous system (CNS) involvement with malignant cells (≤ 2 months prior to consenting);
  • Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings); the principal investigator is the final arbiter of this criterion;
  • Positive HIV serology or viral RNA;
  • Pregnancy (positive serum β human chorionic gonadotropin [HCG] test) or breast-feeding;
  • Fertile men or women unwilling to use effective forms of birth control or abstinence for one year after transplantation;
  • Bovine product allergy.

US Trial Locations

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

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