NCT07052370 · St. Jude Children's Research Hospital
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
What this study is about
This is a phase I, forward-looking 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.
View original scientific description
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.
Interventions
DRUG
Thymoglobulin
IV
DRUG
Cyclophosphamide
IV
DRUG
Fludarabine
IV
DRUG
Thiotepa
IV
DRUG
Melphalan
IV
DRUG
Mesna
IV
DRUG
Filgrastim
IV
DRUG
Blinatumomab
IV
DEVICE
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 measures
Number of participants experiencing grade 3-4 GVHD and/or transplant related mortality (TRM).
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
- Memphis, Tennessee
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations