CD19-CAR T Cell Therapy After Transplant for Pediatric Leukemia and Lymphoma
This study is for children and young adults (up to 21 years old) with high-risk CD19-positive B-cell leukemia (ALL) or lymphoma that has come back or is hard to treat. It's looking at a new approach after a special type of stem cell transplant from a partially matched family member. The study will give a chemotherapy regimen including Anti-Thymocyte Globulin, Cyclophosphamide, Fludarabine, and Thiotepa, followed by a transplant. Then, patients will receive CD19-CAR T cells (a type of immunotherapy where a patient's own immune cells are modified to fight cancer). The main goals are to see if this combined treatment is safe and practical within the first 100 days after transplant.
- Study design
- This is a Phase I study, meaning it's an early-stage study to test safety. It plans to enroll 70 participants.
- What's involved
- Participants will receive a conditioning chemotherapy regimen, followed by a stem cell transplant, and then an infusion of CD19-CAR T cells. They will be monitored for safety and effectiveness.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and feasibility will be assessed within 100 days post-transplant, with some assessments within the first 60 days. Longer-term survival and other outcomes will be estimated at 1 year.
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CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Swati Naik, MBBS · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital
Who to contact
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Do you actually qualify for this trial?
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What this trial measures
- To assess the safety of combining CD19-CAR(Mem) T cells after TCRαβ+/CD19 depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies.This will be assessed 100 days post-HCT
The primary analysis will compute the sample proportions and corresponding binomial exact 95% confidence intervals among evaluable patients for the following toxicities (separately for each toxicity) within 100 days post-HCT: 1) Severe aGVHD defined as Grade 3-4 aGVHD 2) Severe CRS defined as Grade 4 CRS that does not resolve to grade 3 or lower within 72 hours of onset 3) Severe ICANS defined as Grade 4 ICANS that does not resolve to grade 3 or lower within 72 hours of onset 4) TRM defined as death without prior relapse or disease progression within 100 days post-HCT 5) Other toxicity data will also be reported for a complete safety assessment of the study regimen.
- To assess the 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.This will be assessed in the first 60 days post-HCT
this will be measured by the failure to receive CD19-CAR(Mem) T cells among patients who received HCT. The number of patients who fail to receive addback will be reported as the proportion who were unable to receive addback within 60 days post-HCT