Recruiting
Phase 1

CD45RA-depleted DLI

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT07052370

Conditions

Hematologic Malignancy

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Accepted

Interventions

Thymoglobulin

Cyclophosphamide

Fludarabine

Thiotepa

Melphalan

Study Details

Brief summary:

This is a phase I, prospective clinical trial studying the safety and feasibility of providing early memory T-cell DLI.

The primary objective is:

\- To assess the safety and feasibility of early CD45RA-depleted DLI administration.

The secondary objectives are

  • To assess the safety and feasibility of the addition of blinatumomab in the early post-transplant period in patients with CD19+ malignancy.
  • To measure and describe the pharmacokinetics of rabbit ATG in HCT recipients on this study.

Conditions

Hematologic Malignancy

Study ID

NCT07052370

Start date

Sep 25, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Accepted

Inclusion Criteria:

Recipient:

  • Age less than or equal to 21 years
  • High risk hematologic malignancy whereas allogeneic transplantation is the current standard of care. This includes (but is not limited to):

  • High risk ALL in CR1 or CR2,
  • any ALL in CR3 or subsequent;
  • AML in high risk CR1 (AML diagnosis includes myeloid sarcoma),
  • any AML in CR2 or subsequent,
  • any therapy related AML;
  • MDS (primary or secondary),
  • NK cell, biphenotypic, or undifferentiated leukemia/lymphoma in CR1 or subsequent;
  • CML in accelerated phase, or in chronic phase with persistent molecular positivity or intolerance to tyrosine kinase inhibitor, or a history of blast crisis.
  • If prior CNS leukemia, it must be treated and in CNS CR
  • Left ventricular ejection fraction > 40%, or shortening fraction ≥ 25%
  • Creatinine clearance (CrCl) or glomerular filtration rate (GFR) ≥ 50 ml/min/1.73m2
  • Forced vital capacity (FVC) ≥ 50% of predicted value; or pulse oximetry ≥ 92% on room air if patient is unable to perform pulmonary function testing
  • Karnofsky or Lansky (age dependent) performance score ≥ 50 (See APPENDIX A)
  • Bilirubin ≤ 3 times the upper limit of normal for age
  • Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal for age

Donor:

  • At least single haplotype matched (≥ 4 of 8) family member
  • At least 18 years of age
  • HIV negative
  • Regarding donation eligibility, is identified as either:

  • Completed the process of donor eligibility determination as outlined in 21 CFR 1271 and agency guidance; OR
  • Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 1271

Exclusion Criteria:

Recipient:

  • Has a suitable HLA-identical sibling or suitable 12/12 (HLA-A, B, C, DRB1, DQB1, and DPB1) HLA-matched unrelated donor available in an appropriate time frame.
  • Any other active malignancy other than the one for which this HCT is indicated
  • Received a prior allogeneic HCT at any time
  • Received an autologous HCT within the previous 6 months
  • Pregnant, if female is of childbearing potential, negative test must be confirmed by serum or urine pregnancy test within 14 days prior to enrollment
  • Breast feeding
  • Any current uncontrolled bacterial, fungal or viral infection

Donor:

  • Pregnant, negative test must be confirmed by serum or urine pregnancy test within 14 days prior to enrollment if female
  • If female, breast feeding

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HAP3HCT Treatment

Prior to the infusion of donor cells, a preparative regimen consisting of antibodies and chemotherapy will be given. The preparative regimen includes the following total dosages: ATG 5mg/kg (over days -12 to -10); Cyclophosphamide 60 mg/kg (day -9); Fludarabine 150 mg/m2 (over days -8 to -4); Thiotepa 10 mg/kg (divided in two doses on day -3); Melphalan 70 mg/m2 (over days -2 to -1). Following this regimen the TCRαβ-depleted haploidentical donor product will be given on day 0 (subsequent infusion given on day +1 if needed to achieve goal CD34+ cell dose. Approximately 2 weeks later the memory cell donor lymphocyte infusion (DLI) will be given at a dose previously determined to be safe and effective.

Blinatumomab will be empirically added for patients with CD19+ malignancy and given at least four weeks after the memory cell DLI.

Interventions

Thymoglobulin

IV

Cyclophosphamide

IV

Fludarabine

IV

Thiotepa

IV

Melphalan

IV

Mesna

IV

Filgrastim

IV

Blinatumomab

IV

CliniMACS

The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest.

Primary outcome measure

  • Number of participants experiencing grade 3-4 GVHD and/or transplant related mortality (TRM). [ Time Frame: Within 100 days post-transplant infusion ]

Central Contacts and Locations

Central contacts

Brandon Triplett, MD

8662785833referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Brandon Triplett, MD

866-278-5833referralinfo@stjude.org

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Jun 2, 2026

Last verified

Jun, 2026

Keywords

  • Hematopoietic Cell Transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-06-02.