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TCRαβ-depleted Progenitor Cell Graft with Early Memory T-cell DLI for Hematologic Malignancies

This study is for children and young adults (up to 21 years old) with high-risk blood cancers (hematologic malignancies) that are in remission but have a high chance of coming back. It's testing a new way to do a stem cell transplant using cells from a partially matched family member. You would receive chemotherapy (Thymoglobulin, Cyclophosphamide, Fludarabine, Thiotepa, Melphalan) before getting the donor cells. The study is looking at the safety of giving these special donor cells, which include progenitor (blood-making) cells and memory T-cells (a type of white blood cell), and if adding Blinatumomab is safe for those with CD19+ cancers. The main goal is to see how many participants experience severe graft-versus-host disease (GVHD, when donor cells attack your body) or transplant-related death within 100 days after the transplant. This is a Phase 1 study, meaning it's focused on safety. The study plans to enroll 30 participants, but its current status is unclear.

Study design
This is a Phase 1, interventional study designed to learn about the safety and feasibility of this new transplant method. It plans to enroll 30 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary safety outcomes are measured within 100 days post-transplant infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07052370

TCRαβ-depleted Progenitor Cell Graft With Early Memory T-cell DLI, Plus Selected Use of Blinatumomab, in naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies

Recruiting
PHASE1Up to 21InterventionalTreatment
St. Jude Children's Research Hospital
~30 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:ThymoglobulinCyclophosphamideFludarabineThiotepaMelphalanMesna

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants experiencing grade 3-4 GVHD and/or transplant related mortality (TRM).
Measured over Within 100 days post-transplant infusion

Conditions

Hematologic Malignancy

Explore related trials

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaChronic Myeloid Leukemia, BCR-ABL1 PositiveHematologic NeoplasmMyelodysplastic SyndromeCD19 Gene

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Brandon Triplett, MD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital

Who to contact

Brandon Triplett, MD
[email protected]
8662785833
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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

What this trial measures

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

    Safety will be measured by monitoring for the incidence of grade 3-4 GVHD as well as any transplant related mortality experience. Feasibility monitoring will include 1) failure to receive protocol directed DLI among the evaluable participants; and 2) the number of days from transplant infusion to DLI infusion among evaluable participants.