Safety Study of Gene Modified Donor T Cell Infusion After Stem Cell Transplant for Non-Malignant Diseases
| Status: | Active, not recruiting |
|---|---|
| Conditions: | HIV / AIDS, Endocrine, Hematology, Hematology |
| Therapuetic Areas: | Endocrinology, Hematology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any - 55 |
| Updated: | 1/31/2019 |
| Start Date: | February 2015 |
| End Date: | July 2030 |
A Study Evaluating BPX-501 T Cells and AP1903 for Prevention of Graft Versus Host Disease (GVHD) After Haploidentical, Related, T Cell-Depleted Hematopoietic Cell Transplantation for Non-Malignant Diseases
The purpose of this study is to determine a safe dose of BPX-501 gene modified T cells
infused after a haplo-identical stem cell transplant to facilitate engraftment and the safety
of AP1903 on day 7 to prevent GVHD.
infused after a haplo-identical stem cell transplant to facilitate engraftment and the safety
of AP1903 on day 7 to prevent GVHD.
This is a single arm dose finding study evaluating the safety and efficacy of a BPX 501
infusion (T cells genetically modified with the inducible Caspase 9 suicide gene) of 3x10E6
to 1X10E7 cells/kg followed by an AP1903 infusion on day 7 after a partially mismatched,
related, T cell-depleted hematopoietic cell transplantation (HCT) in patients with
non-malignant diseases. The purpose of this clinical trial is to determine the dose of BPX
501 T cell infusion with subsequent planned infusion of AP1903 which can facilitate
engraftment and prevent the occurrence of GVHD.
infusion (T cells genetically modified with the inducible Caspase 9 suicide gene) of 3x10E6
to 1X10E7 cells/kg followed by an AP1903 infusion on day 7 after a partially mismatched,
related, T cell-depleted hematopoietic cell transplantation (HCT) in patients with
non-malignant diseases. The purpose of this clinical trial is to determine the dose of BPX
501 T cell infusion with subsequent planned infusion of AP1903 which can facilitate
engraftment and prevent the occurrence of GVHD.
Inclusion Criteria:
1. Patient must meet eligibility criteria for allogeneic transplantation
2. Males or females
3. Age < 55 years old and > 4 months
4. Diagnosis of a nonmalignant disorder considered treatable by HCT.
5. Lack of suitable conventional donor
Exclusion Criteria:
1. Serious organ dysfunction
2. Pregnant or breast-feeding
3. Evidence of HIV infection
4. Bovine product allergy
5. Patients with an active infectious disease
We found this trial at
1
site
Seattle, Washington 98109
Principal Investigator: Lauri Burroughs, M.D.
Phone: 206-667-6993
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