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Prophylactic TCRaB+ and CD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Transplant in High-Risk Patients With Hematologic Malignancies | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT07285668•University of Wisconsin, Madison

View on ClinicalTrials.gov

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.

Detailed Description

Primary Objectives * To assess safety of prophylactic TCRαβ+/CD19+ depleted donor lymphocyte infusion (αβT/B dep-DLI) after allogeneic stem cell transplant (allo-SCT) in high-risk patients with hematologic malignancies * To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of αβT/B dep-DLI Secondary Objectives * To assess the feasibility of αβT/B dep-DLI * To assess additional safety parameters after αβT/B dep-DLI * To assess the efficacy of αβT/B dep-DLI For the dose escalation phase: Maximum Tolerated Dose (MTD) and Maximum Administered Dose (MAD) is defined as the highest dose level where less than 2 of 6 participants experience a dose limiting toxicity (DLT). Each dose level will be followed for DLTs until day 28 post donor lymphocyte infusion (DLI). Starting at dose level 1: * If 0 of 3 participants experiences DLT, increase to next dose level for next 3 participants. * If 1 of 3 participants experience DLT, enroll 3 participants at same dose level. * If no additional DLTs (1 of 6), move on to next dose level. * If 2 of 6 participants experience DLT, enroll 3 participants into lower dose level. * If 0 or 1 participants experience DLT at lower level, this will be the MTD. Once the MTD or MAD is determined, an expansion cohort will be enrolled into that dose level. All participants will be followed for 2 years after DLI.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+5 more criteria

Exclusion Criteria

•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

Locations (1)

UW Carbone Cancer Center

Madison, Wisconsin, United States

Key Dates

Start Date

February 26, 2026

Primary Completion Date

February 1, 2029

Completion Date

February 1, 2031

Last Updated

March 3, 2026

Enrollment

ESTIMATED participants

Conditions

Hematologic Malignancies

Interventions

Allogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells

DEVICE

Contacts

Cancer Connect

CONTACT

800-622-8922 clinicaltrials@cancer.wisc.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Prophylactic TCRaB+ and CD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Transplant in High-Risk Patients With Hematologic Malignancies

Inclusion Criteria

Exclusion Criteria

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