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 now · Phase 1

Conditions studied: Hematologic Malignancy

In brief

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.

Key facts

Study ID

NCT07052370

Run by

St. Jude Children's Research Hospital

People needed

30

Starts

2025-09-25

Expected to finish

2030-12-01

Last updated by the study team

2026-06-02

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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