Actively Recruiting
CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma
Led by St. Jude Children's Research Hospital · Updated on 2026-05-11
70
Participants Needed
1
Research Sites
495 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to learn more about newer methods of transplanting blood cells donated by a partially matched family member to children with high-risk CD19 positive leukemia ALL. Primary Objective: \- To assess the safety and feasibility of combining CD19-CAR(Mem) T cells after TCRαβ+/CD19 depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies. Secondary Objectives: * To estimate 1-year post-transplant overall survival, event-free survival, and GVHD-free relapse-free survival (GRFS). * To estimate cumulative incidence of engraftment, acute and chronic GVHD, and immune-related adverse events, including CRS and ICANS.
CONDITIONS
Official Title
CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient age less than or equal to 21 years
- Diagnosis of high-risk CD19+ B-cell acute lymphoblastic leukemia (ALL) in first or second complete remission (CR1 or CR2), or any CD19+ B-cell ALL in third or later remission
- If prior central nervous system (CNS) leukemia, it must be treated and in CNS complete remission
- Left ventricular ejection fraction greater than 40% or shortening fraction at least 25%
- Creatinine clearance or glomerular filtration rate at least 50 ml/min/1.73m2
- Forced vital capacity at least 50% of predicted value, or pulse oximetry at least 92% on room air if unable to perform pulmonary function testing
- Karnofsky or Lansky performance score of 50 or higher
- Bilirubin no more than three times the upper limit of normal for age
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) no more than five times the upper limit of normal for age
- Donor is a family member matched at least 4 of 8 HLA alleles
- Donor age at least 18 years
- Donor is HIV negative
- If donor is sexually active, agrees to use birth control until two weeks after mobilization and apheresis procedures
- Donor meets eligibility requirements per regulatory guidelines or has urgent medical need declaration
You will not qualify if you...
- Patient has a suitable fully matched sibling or 12/12 matched unrelated donor available in a timely manner
- Patient has any active malignancy other than the one being treated with transplant
- Patient has undergone prior allogeneic hematopoietic cell transplantation
- Female patient of childbearing potential is pregnant (confirmed by test within 14 days prior to enrollment)
- Patient agrees to use birth control until six months after T cell infusion if sexually active
- Patient is breastfeeding
- Patient has any severe uncontrolled bacterial, fungal, or viral infection
- Donor is pregnant (confirmed by test within 14 days prior to enrollment if female)
- Female donor is breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
S
Swati Naik, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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