Study of Matched Unrelated Donor T Cell Infusion for Hematologic Malignancies After Allo-HSCT

• Status: Withdrawn
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bellicum Pharmaceuticals

Criteria

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.