Study of Gene Modified Donor T Cell Infusion in Patients With Recurrent Disease After Allogeneic Transplant
Running, not enrolling · Phase 1
Conditions studied: Leukemia, Myelodysplastic Syndromes, Lymphoma, Multiple Myeloma, Hematologic Neoplasms
In brief
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.
Key facts
- Study ID
- NCT02477878
- Run by
- Bellicum Pharmaceuticals
- People needed
- 10
- Starts
- 2016-07-01
- Expected to finish
- 2033-01-01
- Last updated by the study team
- 2022-07-12
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects aged >18yrs and < 65yrs
- Clinical diagnosis of one of the following adult hematological malignancies
- Leukemia
- Myelodysplastic Syndromes
- Lymphomas
- Multiple myeloma
- Other high-risk hematologic malignancies eligible for stem cell transplantation per institutional standard Life expectancy >10 weeks
- Evidence of recurrent disease that presents > 100 days or minimal residual disease (MRD) that presents > 30 days after one of the following:
- Matched related HSCT
- Mismatched related HSCT
- Signed patient informed consent;
- 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
- Performance status: Karnofsky score > 50%
- Subjects with adequate organ function as measured by:
- Bone marrow:
- > 25% donor T-cell chimerism
- ANC >1 x 10E9/L
- Cardiac: left ventricular ejection fraction at rest must be >45%.
- Hepatic: direct bilirubin ≤ 3 x upper limit of normal, or AST/ALT ≤ 5 x upper limit of normal
- Renal: creatinine ≤ 2x of ULN for age
- Pulmonary: FEV 1, FVC, DLCO (diffusion capacity) > 50% predicted (corrected for hemoglobin)
You may not qualify if…
- ≥ Grade II acute GVHD or chronic extensive GVHD due to a previous allograft at time of screening;
- Active CNS involvement by malignant cells;
- 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 βHCG test) or breast-feeding;
- Subjects of reproductive potential unwilling to use effective forms of birth control or abstinence for a year after transplantation;
- Bovine product allergy
Where it is running
- BMT Program at Northside Hospital — Atlanta, Georgia, United States
- University of Kansas — Westwood, Kansas, United States
- Roswell Park — Buffalo, New York, United States
- Oregon Health & Science University — Portland, Oregon, United States
- UT Southwestern Medical Center — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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