Prophylactic TCRaB+ and CD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Transplant in High-Risk Patients With Hematologic Malignancies
NCT ID: NCT07285668
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
38 participants
INTERVENTIONAL
2026-01-31
2031-01-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation Cohort Level 1
1 x 10\^6 CD3-CD56+/kg
Allogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells
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.
Dose Escalation Cohort Level 2
2 X 10\^6 CD3-CD56+/kg
Allogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells
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.
Dose Escalation Cohort Level 3
5 X 10\^6 CD3-CD56+/kg
Allogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells
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.
Dose Escalation Cohort Level -1
0.5 x 10\^6 CD3-CD56+/kg
Dose to be used only if Dose Level 1 is not tolerated.
Allogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells
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.
Interventions
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Allogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells
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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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 preferred for such patients.
* 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
18 Years
75 Years
ALL
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Jacques Galipeau, MD, FRCP(C)
Role: STUDY_DIRECTOR
UW School of Medicine and Public Health
Hongtao Liu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UW Carbone Cancer Center
Locations
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UW Carbone Cancer Center
Madison, Wisconsin, United States
Countries
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Central Contacts
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Related Links
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Stem Cell and Regenerative Medicine Center
Other Identifiers
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UW25034
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 8/8/25
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/MEDICINE/HEM-ONC
Identifier Type: OTHER
Identifier Source: secondary_id
2025-1405
Identifier Type: -
Identifier Source: org_study_id