A Phase 1-2 Dose Escalation Study Evaluating Safety and Feasibility of BPX-501 T Cells after Partially Mismatched, Related, T Cell-Depleted HSCT
The purpose of this study is to find a safe and effective dose of the study T cell product that can be given to patients after a donor stem cell transplant. We want to find out what effects, good and/or bad, the study T cell product has on you and your blood cancer.
Cancers of the blood for which a donor stem cell transplant is considered a suitable treatment. Conditions include: Acute Leukemia, T lymphoblastic lymphoma, Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, High risk Myelodysplastic Syndrome, Non-Hodgkin’s Lymphoma. Other disease criteria apply as per the study investigator.
-Patients with cancers of the blood for which a donor stem cell transplant is considered a suitable treatment.
-Patients must have received certain types of chemotherapy (as determined by the Investigator) within 3 months of signing consent.
-Lack of a suitable matched conventional donor or presence of rapidly progressive disease not permitting time to identify an unrelated donor.
-Must meet other criteria to ensure patient is healthy enough to receive a transplant.
-Donors must be between ages 18 and 70 and must also consent to the study and meet certain eligibility criteria related to health and health history.
18 - 65
Healthy Volunteers Needed
Duration of Participation
In addition to the standard examinations that all patients receiving a stem cell transplant have after the transplant, participants will be asked to return to the clinic every 6 months for 5 years for checkups, then yearly for 10 years for blood samples (a total of 15 years). If participants do not live near the transplant center, these evaluations can be done by a local doctor but the study doctors will ask for the results to make sure there are no long-term side effects.
Bellicum Pharmaceuticals, Inc (Houston, Texas)