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NCT07257419 · ClinicalTrials.gov registry record · Phase 1
CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma
A Phase 1 study of Hematologic Malignancy and Hematopoietic Cell Transplantation, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT07257419: Recruiting Phase 1 study of Hematologic Malignancy and Hematopoietic Cell Transplantation, sponsored by St. Jude Children's Research Hospital.
NCT07257419 is a Phase 1 study of Hematologic Malignancy and Hematopoietic Cell Transplantation that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 60 participants, below the 227-participant average among 48 other Hematologic Malignancy trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07257419, a Phase 1 study of Hematologic Malignancy and Hematopoietic Cell Transplantation, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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 d
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Mesna
- DRUG Thiotepa
- DRUG Anti-Thymocyte Globulin (Rabbit)
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-03-03 |
| Est. Completion | 2035-12 |
| Phase | Phase 1 |
What NCT07257419 shows while recruiting
NCT07257419 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 227-participant average among 48 other Hematologic Malignancy trials with a reported enrollment target (74% lower).
The record links to 3 conditions, with Hematologic Malignancy appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT07257419 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT07257419 about?
NCT07257419 is a clinical study titled "CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma". 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+...
What is the current status of trial NCT07257419?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2026-03-03. Estimated completion is 2035-12.
What conditions does trial NCT07257419 study?
This clinical trial studies the following conditions: Hematologic Malignancy, Hematopoietic Cell Transplantation, Relapsed Pediatric ALL.
What interventions are being tested in trial NCT07257419?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Mesna (DRUG), Thiotepa (DRUG), Anti-Thymocyte Globulin (Rabbit) (DRUG).
Who is sponsoring clinical trial NCT07257419?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07257419 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hematologic Malignancy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07257419's enrollment target sits among peer trials
60 21st of 48 higher than 25 of 48 other Hematologic Malignancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hematologic Malignancy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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