Prophylactic TCRaB+ and CD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Transplant in High-Risk Patients With Hematologic Malignancies
Phase I Study of Prophylactic TCRαβ+ and CD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Transplant in High-Risk Patients With Hematologic Malignancies
University of Wisconsin, Madison
38 participants
Feb 26, 2026
INTERVENTIONAL
Conditions
Summary
This study is being done to assess the safety and determine the maximum tolerable dose (MTD) of TCRαβ+/CD19+-depleted Donor Lymphocyte Infusion (αβT/B dep-DLI) after allogeneic stem cell transplant (allo-SCT) in highrisk patients with hematologic malignancies.
Eligibility
Inclusion Criteria15
- Patients with high-risk myeloid or lymphoid malignancies determined to be eligible to undergo a related, allo-SCT using Disease Risk Index (DRI), including the conditions listed below. These criteria apply BEFORE cyto-reductive therapy given within 28 days of planned conditioning:
- Refractory acute myelogenous or lymphoid leukemia
- Relapsed acute myelogenous or lymphoid leukemia
- Myelodysplastic syndromes with 5 percent or more blasts
- Chronic myelogenous leukemia in chronic phase 3 or more, blast phase presently, or second accelerated phase
- Recurrent or refractory malignant lymphoma or Hodgkin's disease with less than a partial response at transplant
- High risk chronic lymphocytic leukemia defined as no response or stable disease to the most recent treatment regimen
- Other high risk hematologic malignancies for which allo-SCT is deemed clinically necessary per PI and based on institutional standards
- The donor for the allo-SCT will have been identified prior to participant recruitment and must be:
- Related AND
- Matched OR mismatched OR haploidentical at Human Leukocyte Antigen (HLA) HLA-A, -B, -C, and -DRB1 by molecular methods
- Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
- Ability to understand and willingness to sign written informed consent document
- Willing to comply with all study procedures and be available for the duration of the study
- Individuals in sexual relationships that could result in pregnancy or impregnation of their partner must use an acceptable method of contraception§ from enrollment until 4 weeks after completing study treatment.
Exclusion Criteria8
- Poor organ function as follows (According to the pre-transplant workups results):
- Creatinine greater than or equal to 2.0 mg/dL
- Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT) greater than or equal to 5 x Upper Limit of Normal (ULN). Liver biopsy per clinician discretion.
- Bilirubin greater than or equal to 3 x ULN (unless Gilbert's syndrome)
- Diffusing capacity of the Lungs for Carbon Monoxide (DLCO) less than 50 percent corrected for hemoglobin
- Left ventricular ejection fraction or shortening fraction less than 40 percent
- Patients with uncontrolled intercurrent illness
- Patients with psychiatric illness/social situations that would limit compliance with study requirements
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Interventions
Single intravenous dose of allogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells (i.e., αβT/B dep-DLI), where the dose is based on the natural killer (NK) cell (CD3-CD56+) content in the DLI product. Each participant will receive one of four DLI doses depending upon cohort to which the participant is enrolled.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07285668