Study of Gene Modified Donor T Cell Infusion in Patients With Recurrent Disease After Allogeneic Transplant

• Status: Active, not recruiting
• Trial end date: 2033-01-01
• Target enrollment: 0
• Participant gender: All

Summary

A Phase I study of BPX-501 T cell infusion in adults with recurrent or minimal residual disease (MRD) hematologic malignancies post-allogeneic transplant. The treatment consists of increasing doses of BPX-501 T cell infusions to achieve a clinical response. Rimiducid will be investigated for the treatment of aGvHD after BPX-501 T cell infusion to determine a dose that can mitigate GvHD and preserve the graft versus leukemia effect.

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

Details

• Lead Sponsor: Bellicum Pharmaceuticals

Criteria

Inclusion Criteria:

1. Subjects aged >18yrs and < 65yrs

2. Clinical diagnosis of one of the following adult hematological malignancies

1. Leukemia

2. Myelodysplastic Syndromes

3. Lymphomas

4. Multiple myeloma

5. Other high-risk hematologic malignancies eligible for stem cell transplantation per institutional standard Life expectancy >10 weeks

3. Evidence of recurrent disease that presents > 100 days or minimal residual disease (MRD) that presents > 30 days after one of the following:

1. Matched related HSCT

2. Mismatched related HSCT

4. Signed patient informed consent;

5. A minimum genotypic identical match of 4/8 is required, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, and HLA- DRB1

6. Performance status: Karnofsky score > 50%

7. Subjects with adequate organ function as measured by:

1. Bone marrow:

• > 25% donor T-cell chimerism

• ANC >1 x 10E9/L

2. Cardiac: left ventricular ejection fraction at rest must be >45%.

3. Hepatic: direct bilirubin ≤ 3 x upper limit of normal, or AST/ALT ≤ 5 x upper limit of normal

4. Renal: creatinine ≤ 2x of ULN for age

5. Pulmonary: FEV 1, FVC, DLCO (diffusion capacity) > 50% predicted (corrected for hemoglobin)

Exclusion Criteria:

1. ≥ Grade II acute GVHD or chronic extensive GVHD due to a previous allograft at time of screening;

2. Active CNS involvement by malignant cells;

3. 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;

4. Positive HIV serology or viral RNA

5. Pregnancy (positive serum βHCG test) or breast-feeding;

6. Subjects of reproductive potential unwilling to use effective forms of birth control or abstinence for a year after transplantation;

7. Bovine product allergy