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NCT04881240 · ClinicalTrials.gov registry record · Phase 1
Study of CD19-directed Allogeneic Memory T-cell Therapy for Relapsed/Refractory CD19+ Leukemia
A Phase 1 study of Pediatric ALL and Acute Lymphoblastic Leukemia, in Relapse, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04881240: Recruiting Phase 1 study of Pediatric ALL and Acute Lymphoblastic Leukemia, in Relapse, sponsored by St. Jude Children's Research Hospital.
NCT04881240 is a Phase 1 study of Pediatric ALL and Acute Lymphoblastic Leukemia, in Relapse that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 60 participants, below the 1,645-participant average among 21 other Pediatric ALL trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04881240, a Phase 1 study of Pediatric ALL and Acute Lymphoblastic Leukemia, in Relapse, 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
This is a Phase I clinical study evaluating the safety and maximum tolerated dose of a novel CAR T-cell product: allogeneic memory (CD45RA- negative) T-cells expressing a CD19-specific CAR 41BBz (CD19-CAR.CD45RA- negative T-cells) for the treatment of patients ≤ 21 years old with relapsed and/ or refractory CD19-positive leukemia. Primary Objective To determine the maximum tolerated dose (MTD) and characterize the safety profile and dose-limiting toxicities (DLTs) of treatment with allogeneic CD19-CAR.CD45RA-negative T-cells in pediatric, adolescent and young adult patients ≤ 21 years of age, with relapsed and/or refractory CD19-positive leukemia. Secondary Objectives * To evaluate the anti-leukemic activity of allogeneic CD19-CAR.CD45RA-negative T-cells. * To determine rates and severity of graft-versus-host-disease (GVHD) after treatment with allogeneic CD19-CAR.CD45RA-negative T-cells. Exploratory Objectives * To study the expansion, persistence and phenotype of allogeneic CD19-CAR.CD45RA-negative T-cells. * To characterize the cytokine profile in the peripheral blood and CSF after treatment with allogeneic CD19-CAR.CD45RA-negative T-cells. * To assess whether allogeneic CD19-CAR.CD45RA-negative T-cells acquire functional versus exhaustion-associated epigenetic programs. * To determine immune reconstitution post treatment, and the clonal structure and endogenous repertoire of allogeneic CD19-CAR.CD45RA-negative T-cells and relate inferred specificity to CAR response profiles. * To characterize incidence and mechanisms of relapse post-therapy with allogeneic CD19-CAR.CD45RA-negative T-cells.
Primary Outcome
This phase I study includes dose escalation/de-escalation based on dose limiting toxicity (DLT) assessment to determine the maximum tolerated dose (MTD) of allogeneic, CD19-CAR.CD45RA-negative cells.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Mesna
- DEVICE CliniMACS
- BIOLOGICAL CD19-CAR(Mem) T-cells
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-02-14 |
| Est. Completion | 2028-07-01 |
| Phase | Phase 1 |
What NCT04881240 shows while recruiting
NCT04881240 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 1,645-participant average among 21 other Pediatric ALL trials with a reported enrollment target (96% lower).
The record links to 3 conditions, with Pediatric ALL appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04881240 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT04881240 about?
NCT04881240 is a clinical study titled "Study of CD19-directed Allogeneic Memory T-cell Therapy for Relapsed/Refractory CD19+ Leukemia". This is a Phase I clinical study evaluating the safety and maximum tolerated dose of a novel CAR T-cell product: allogeneic memory (CD45RA- negative) T-cells expressing a CD19-specific CAR 41BBz (CD19-CAR.CD45RA- negative T-cells) for the treatment of patients ≤ 21 years old with relapsed and/ or re...
What is the current status of trial NCT04881240?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2024-02-14. Estimated completion is 2028-07-01.
What conditions does trial NCT04881240 study?
This clinical trial studies the following conditions: Pediatric ALL, Acute Lymphoblastic Leukemia, in Relapse, Acute Lymphoblastic Leukemia, Refractory.
What interventions are being tested in trial NCT04881240?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Mesna (DRUG), CliniMACS (DEVICE), CD19-CAR(Mem) T-cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT04881240?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04881240 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
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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 NCT04881240's enrollment target sits among peer trials
60 12th of 21 higher than 10 of 21 other Pediatric ALL trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pediatric ALL 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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