Actively Recruiting
Haploidentical Hematopoietic Stem Cell Transplantation With Ex Vivo TCR Alpha/Beta and CD19 Depletion in Pediatric Hematologic Malignancies
Led by Washington University School of Medicine · Updated on 2026-03-16
50
Participants Needed
1
Research Sites
343 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This single arm pilot phase I study with safety run-in is designed to estimate the safety and efficacy of a familial mismatched or haploidentical hematopoietic stem cell transplantation (haplo-HSCT) using a novel graft modification technique (selective αβ-TCR and CD19 depletion).
CONDITIONS
Official Title
Haploidentical Hematopoietic Stem Cell Transplantation With Ex Vivo TCR Alpha/Beta and CD19 Depletion in Pediatric Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of high-risk pediatric hematologic malignancy including B cell ALL in first, second, or third remission with specific risk features
- T cell ALL in first or subsequent remission with measurable residual disease
- AML in first or subsequent remission with defined high-risk genetic or residual disease features
- Mixed phenotype or undifferentiated leukemia, therapy-related leukemia, NK cell lineage leukemia, myelodysplastic syndrome, or juvenile myelomonocytic leukemia
- Prior hematopoietic stem cell transplant allowed if no active graft-versus-host disease and off immunosuppression for at least 3 months
- Availability of a familial haploidentical donor with at least one identical allele at HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1 loci (minimum 5/10 match)
- Age 30 years or younger
- Lansky or Karnofsky performance status greater than 50%
- Adequate organ function including cardiac (LVEF 40%), hepatic (bilirubin and liver enzymes within limits), renal (GFR 60 mL/min/1.73m2), and pulmonary (oxygen saturation 92% and lung function tests 50% predicted)
- Agreement to use effective contraception if of childbearing potential
- Ability to understand and sign informed consent
You will not qualify if you...
- Presence of an available matched related donor
- Active non-hematologic malignancy
- Current treatment with other investigational agents at transplant
- Active central nervous system or extramedullary disease
- History of allergic reactions to conditioning agents
- Uncontrolled illness including active infection, symptomatic heart failure, or unstable arrhythmia
- Significant anti-donor HLA antibodies per institutional standards
- Presence of a major disorder contraindicating hematopoietic stem cell transplantation
- Pregnancy or breastfeeding; women of childbearing potential must have negative pregnancy test within 14 days before conditioning
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
T
Thomas Pfeiffer, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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