This phase I trial studies the safety, side effects, and best dose of TCRαβ+ and CD19+ depleted donor lymphocyte infusion after a donor stem cell transplant in preventing a return of cancer (relapse) in patients with high-risk blood cancers. Previously, patients who have relapsed after a donor stem cell transplant have been given infusions of donor white blood cells called donor lymphocyte infusions (DLI) to boost their immune function and fight the cancer. This approach is typically associated with graft-versus-host disease (GVHD), a body-wide disorder that occurs when the specific cells from the transplanted DLI product recognizes the host as foreign and attacks their cells. GVHD can be difficult to treat and even be fatal. Depleting certain types of cells (TCRαβ+ T-cells and CD19+ B-cells) in the DLI product may work better in avoiding the side effect of GVHD, while allowing the other lymphocytes in the DLI product to fight the host’s cancer and to prevent serious life-threatening infections.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07285668.
Locations matching your search criteria
United States
Wisconsin
Madison
University of Wisconsin Carbone Cancer Center - University HospitalStatus: Active
Contact: Hongtao Liu
Phone: 608-265-0106
PRIMARY OBJECTIVES:
I. To assess safety of prophylactic allogeneic TCR alpha/beta/CD19-positive cell-depleted peripheral blood mononuclear cells (TCRαß+/CD19+ depleted donor lymphocyte infusion [αßT/B dep-DLI]) after allogeneic stem cell transplant (allo-SCT) in high-risk patients with hematologic malignancies.
II. To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of prophylactic αßT/B dep-DLI after allo-SCT in high-risk patients with hematologic malignancies.
SECONDARY OBJECTIVES:
I. To assess additional safety parameters after allo-SCT in high-risk patients with hematologic malignancies.
II. To assess the efficacy of prophylactic αßT/B dep-DLI after allo-SCT in high-risk patients with hematologic malignancies.
III. To assess the feasibility of prophylactic αßT/B dep-DLI after allo-SCT in high-risk patients with hematologic malignancies.
CORRELATIVE/EXPLORATORY OBJECTIVES:
I. To assess the effect of regulatory T cells on safety and efficacy of prophylactic αßT/B dep-DLI following allo-SCT in high-risk patients with hematologic malignancies.
II. To assess the efficacy of αßT/B dep-DLI in eliminating measurable residual disease (MRD) in patients with myeloid leukemia, myelodysplastic syndrome (MDS), acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL).
OUTLINE: This is a dose-escalation study of αßT/B dep-DLI followed by a dose-expansion study.
Donor participants undergo leukapheresis for 3-4 hours over 1 to 2 days on study. Approximately 35 days after completion of standard of care (SOC) allo-SCT, patients receive αßT/B dep-DLI intravenously (IV) over 30-90 minutes. NOTE: Patients may receive αßT/B dep-DL up to 100 days post-SOC allo-SCT or later per principal investigator assent. Patients also undergo bone marrow aspiration and/or blood sample collection throughout the study. In addition, patients with lymphoma undergo bone marrow biopsy and/or computed tomography (CT) with or without positron emission tomography (PET) scans throughout the study.
After completion of study αßT/B dep-DL treatment, patients are followed up at 1-2 weeks and at 4 weeks, then at 6, 12, 18, and 24 months post SOC allo-SCT.
Lead OrganizationUniversity of Wisconsin Carbone Cancer Center - University Hospital
Principal InvestigatorHongtao Liu
