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

Last updated: March 2, 2026
Sponsor: University of Wisconsin, Madison
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hematologic Neoplasms

Treatment

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

Clinical Study ID

NCT07285668
2025-1405
Protocol Version 8/8/25
SMPH/MEDICINE/HEM-ONC
UW25034
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Patients with high-risk myeloid or lymphoid malignancies determined to be eligibleto undergo a related, allo-SCT using Disease Risk Index (DRI), including theconditions listed below. These criteria apply BEFORE cyto-reductive therapy givenwithin 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 thana partial response at transplant

  • High risk chronic lymphocytic leukemia defined as no response or stable diseaseto the most recent treatment regimen

  • Other high risk hematologic malignancies for which allo-SCT is deemedclinically necessary per PI and based on institutional standards

  • The donor for the allo-SCT will have been identified prior to participantrecruitment 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 thestudy

  • Individuals in sexual relationships that could result in pregnancy or impregnationof their partner must use an acceptable method of contraception§ from enrollmentuntil 4 weeks after completing study treatment.

Exclusion

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 PyruvicTransaminase (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 percentcorrected for hemoglobin

  • Left ventricular ejection fraction or shortening fraction less than 40 percent

NOTE: Exceptions to the above organ function exclusion criteria are allowable only with assent of the PI since the risks and benefits must be addressed for patients with potentially incurable hematologic malignancies. Such exceptions will be clearly documented in the subject's research record and will not be considered a deviation.

  • Patients with uncontrolled intercurrent illness

  • Patients with psychiatric illness/social situations that would limit compliance withstudy requirements

Study Design

Total Participants: 38
Treatment Group(s): 1
Primary Treatment: Allogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells
Phase:
Study Start date:
February 26, 2026
Estimated Completion Date:
February 28, 2031

Study 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.

Connect with a study center

  • UW Carbone Cancer Center

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

  • UW Carbone Cancer Center

    Madison 5261457, Wisconsin 5279468 53792
    United States

    Site Not Available

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