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Hematologic MalignanciesNCT07285668

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

A study testing Allogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells in people with Hematologic Malignancies, run by University of Wisconsin, Madison at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hematologic Malignancies
What is being tested?
Allogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
26 Feb 2026to Feb 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with high-risk myeloid or lymphoid malignancies determined to be eligible to undergo allo-SCT including but not limited to the conditions listed below. These criteria apply at the disease diagnosis or any time prior to the cyto-reductive therapy given before the planned conditioning:
  • Refractory acute myelogenous (AML) or lymphoid leukemia (ALL)
  • Relapsed AML or ALL
  • AML in European LeukemiaNet (ELN) high risk per cytogenetic and mutation
  • Any patients with minimal residual disease (MRD+) disease by flow cytometry or with active disease (not in complete remission (CR)) prior to allo-SCT
  • Myelodysplastic syndromes (MDS) with 5% or more blasts at initial diagnosis, or anytime during their treatment prior to allo-SCT.
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  • Myelodysplastic syndrome (MDS) high risk or very high risk per Revised International Prognostic Scoring System (IPSS-R) or Molecular International Prognostic Scoring System (IPSS-M)
  • Chronic myelogenous leukemia (CML) in chronic phase failed 3 or more treatments, in accelerated or blast phase
  • High risk primary myelofibrosis (PMF) per Dynamic International Prognostic Scoring System (DIPSS)-plus or Mutation-enhanced International Prognostic Scoring System for Transplant-age Patients (MIPSS70+)
  • PMF in accelerated or blast 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 must be:
  • Related AND
  • Matched OR mismatched OR haploidentical at HLA-A, -B, -C, and -DRB1 by molecular methods
  • 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.

Who cannot join

  • Poor organ function as follows (According to the pre-transplant workups results):
  • Creatinine ≥ 2.0 mg/dL
  • SGOT and SGPT ≥ 5 x ULN. Liver biopsy per clinician discretion.
  • Bilirubin ≥ 3 x ULN (unless Gilbert's syndrome)
  • DLCO < 50% corrected for hemoglobin
  • Left ventricular ejection fraction or shortening fraction < 40%
Show all 9Show fewer
  • 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 with study requirements

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • UW Carbone Cancer Center

    Madison, Wisconsin, 53792

    Recruiting

Other trials in United States

About this study

Official title: Phase I Study of Prophylactic TCRαβ+ and CD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Transplant in High-Risk Patients With Hematologic Malignancies

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.

Read the 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.

Being tested
Allogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells
Keywords
allogeneic donor, Lymphocyte Infusion
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

Study groups in NCT07285668
Study groupRoleWhat they receive
Dose Escalation Cohort Level 1Experimental1 x 10^6 CD3-CD56+/kg
Receives: Device: Allogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells
Dose Escalation Cohort Level 2Experimental2 X 10^6 CD3-CD56+/kg
Receives: Device: Allogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells
Dose Escalation Cohort Level 3Experimental5 X 10^6 CD3-CD56+/kg
Receives: Device: Allogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells
Dose Escalation Cohort Level -1Experimental0.5 x 10^6 CD3-CD56+/kg Dose to be used only if Dose Level 1 is not tolerated.
Receives: Device: Allogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events (AEs) from DLI to day 28 post-DLI

    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, incidence of AEs will be reported.

    Measured: up to day 28 post-DLI (approximately day 63 on study)

  2. Maximum Tolerated Dose or Maximum Administered Dose

    MTD/MAD defined as the highest dose level at which less than 2 of 6 participants experience a DLT.

    Measured: up to day 28 post-DLI (approximately day 63 on study)

Secondary outcomes (12)
  1. Incidence of grade II-IV acute Graft-versus-Host Disease (aGVHD) after αβT/B dep-DLI

    To assess additional safety parameters after allo-SCT in high-risk patients with hematologic malignancies, Incidence of grade II-IV aGVHD after αβT/B dep-DLI will be reported.

    Measured: up to day 28 post-DLI (approximately day 63 on study)

  2. Cumulative incidence of severe grade III-IV aGVHD after αβT/B dep-DLI

    To assess additional safety parameters after allo-SCT in high-risk patients with hematologic malignancies, cumulative incidence of severe grade III-IV aGVHD after αβT/B dep-DLI will be reported.

    Measured: up to day 28 post-DLI (approximately day 63 on study)

  3. Chronic Graft-versus-Host Disease (GVHD) incidence after αβT/B dep-DLI

    To assess additional safety parameters after allo-SCT in high-risk patients with hematologic malignancies, chronic GVHD incidence after αβT/B dep-DLI will be reported.

    Measured: up to day 28 post-DLI (approximately day 63 on study)

  4. Efficacy assessed by 1 year Progression Free Survival (PFS)

    To assess the efficacy of prophylactic αβT/B dep-DLI after allo-SCT in high-risk patients with hematologic malignancies, 1 year PFS will be reported.

    Measured: up to 1 year

  5. Efficacy Assessed by Non-Relapse Mortality

    To assess the efficacy of prophylactic αβT/B dep-DLI after allo-SCT in high-risk patients with hematologic malignancies, non-relapse mortality will be reported.

    Measured: up to 2 years

  6. Efficacy Assessed by Overall Survival

    To assess the efficacy of prophylactic αβT/B dep-DLI after allo-SCT in high-risk patients with hematologic malignancies, overall survival will be reported.

    Measured: up to 2 years

  7. Efficacy Assessed by Incidence of Cytomegalovirus (CMV) Reactivation

    To assess the efficacy of prophylactic αβT/B dep-DLI after allo-SCT in high-risk patients with hematologic malignancies, incidence of CMV Reactivation will be reported.

    Measured: up to 2 years

  8. Efficacy Assessed by Incidence of Fungal Infection

    To assess the efficacy of prophylactic αβT/B dep-DLI after allo-SCT in high-risk patients with hematologic malignancies, incidence of fungal infections will be reported.

    Measured: up to 2 years

  9. Efficacy Assessed by Incidence of Full Chimerism (CD3 compartment)

    To assess the efficacy of prophylactic αβT/B dep-DLI after allo-SCT in high-risk patients with hematologic malignancies, incidence of full chimerism will be reported.

    Measured: up to 2 years

  10. Efficacy Assessed by Immunoglobulin Levels

    To assess the efficacy of prophylactic αβT/B dep-DLI after allo-SCT in high-risk patients with hematologic malignancies, quantitative immunoglobulin levels will be reported.

    Measured: up to 2 years

  11. Efficacy Assessed by Lymphocyte Panel Analysis

    To assess the efficacy of prophylactic αβT/B dep-DLI after allo-SCT in high-risk patients with hematologic malignancies, lymphocyte subset panel analysis will be conducted and reported.

    Measured: up to 2 years

  12. Feasibility assessed by percentage of enrolled participants who are able to receive depleted DLI

    To assess the feasibility of prophylactic αβT/B dep-DLI after allo-SCT in high-risk patients with hematologic malignancies, the percentage of enrolled participants who are able to receive depleted DLI will be reported.

    Measured: up to approximately 35 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2025
  2. Study start26 Feb 2026
  3. Primary completionFeb 2029 (estimated)
  4. Study completionFeb 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
This is a single-center, phase I 3x3 dose-escalation study with expansion cohort, open label, non-randomized, non-placebo controlled, single-group assignment study.
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07285668
Sponsor's protocol ID
2025-1405
Other IDs
UW25034, Protocol Version 5/5/26, SMPH/MEDICINE/HEM-ONC
Status last verified
Sep 2026
First submitted
9 Dec 2025
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: The Principal Investigator, Sponsor and funding institutions (if applicable) will ensure that all mechanisms used to share data include proper plans and safeguards to protect the rights and privacy of participants who participate in this research. Data from this study may be requested from other researchers 5 years after the completion of the primary endpoint by contacting the Principal Investigator, Dr. Hongtao Liu.

Questions about this trial

What is this clinical trial studying?

A study testing Allogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells in people with Hematologic Malignancies, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cancer Connect (800-622-8922, clinicaltrials@cancer.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AEs) from DLI to day 28 post-DLI (time frame: up to day 28 post-DLI (approximately day 63 on study)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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