Recruiting

αβT/B dep-DLI

Sponsor:

University of Wisconsin, Madison

Code:

NCT07285668

Conditions

Hematologic Malignancies

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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.

Conditions

Hematologic Malignancies

Study ID

NCT07285668

Start date

Feb 26, 2026

Status verified date

Jul, 2026

Completion date

Feb, 2031

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

• 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%

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

Study Design

Enrollment

38 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation Cohort Level 1

1 x 10\^6 CD3-CD56+/kg

experimental: Dose Escalation Cohort Level 2

2 X 10\^6 CD3-CD56+/kg

experimental: Dose Escalation Cohort Level 3

5 X 10\^6 CD3-CD56+/kg

experimental: 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.

Interventions

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.

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) ]
  • Maximum Tolerated Dose or Maximum Administered Dose [ Time Frame: up to day 28 post-DLI (approximately day 63 on study) ]

Central Contacts and Locations

Central contacts

Locations

UW Carbone Cancer Center

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • allogeneic donor
  • Lymphocyte Infusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-07-24.