OHSU

IRB #

IRB00009375

Title

A Phase 1-2 Dose Escalation Study Evaluating Safety and Feasibility of BPX-501 T Cells after Partially Mismatched, Related, T Cell-Depleted HSCT

Principal Investigator

Richard Maziarz

Study Purpose

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.

Medical Condition(s)

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.

Eligibility Criteria

-Ages 18-65
-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.

Age Range

18 - 70

Healthy Volunteers Needed

No

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.

Minors Included

No

Contact

Nan Subbiah
Email: subbiahn@ohsu.edu
or
Chelsea Kline
Email: kline@ohsu.edu

Sponsor

Bellicum Pharmaceuticals, Inc (Houston, Texas)

Recruitment End

02/01/2025

Compensation Provided

No


Go Back