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NCT06847269 · ClinicalTrials.gov registry record · Phase 2
CAR T CELL Therapy for Pediatric, Adolescent and Young Adult Patients With CD19-Positive Leukemia
A Phase 2 study of Acute Lymphoblastic Leukemia and Refractory Acute Lymphoblastic Leukemia, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT06847269: Recruiting Phase 2 study of Acute Lymphoblastic Leukemia and Refractory Acute Lymphoblastic Leukemia, sponsored by St. Jude Children's Research Hospital.
NCT06847269 is a Phase 2 study of Acute Lymphoblastic Leukemia and Refractory Acute Lymphoblastic Leukemia that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 25 participants, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06847269, a Phase 2 study of Acute Lymphoblastic Leukemia and Refractory Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
CAR19PK is a research study evaluating the use of lymphodepleting chemotherapy and chimeric antigen receptor (CAR) T cell therapy, a type of cellular therapy, for the treatment of refractory and/or relapsed leukemia. For this type of therapy, peripheral (circulating) immune cells are collected and then modified so that they can recognize an antigen, which is a particle present on the surface of a cancer cell. The CD19-CAR T cell product will be manufactured at the St. Jude Children's Research Hospital's Good Manufacturing Practice (GMP) facility. The main purpose of this study is to determine: * Evaluate different doses of fludarabine prior CAR T cell infusion * How your body processes fludarabine and cyclophosphamide, * How long the CAR T cells last in the body, * Whether or not treatment with this therapy is effective in treating people with refractory or relapsed leukemia, and * The side effects of this therapy.
Primary Outcome
Determination of Fludarabine exposure (area under the curve \[AUC\], mg-hr/L) using blood samples collected on days -5, -4 and -3
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Mesna
- BIOLOGICAL CD19-CAR T cell Infusion
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2025-05-21 |
| Est. Completion | 2031-04 |
| Phase | Phase 2 |
What NCT06847269 shows while recruiting
NCT06847269 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT06847269 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT06847269 about?
NCT06847269 is a clinical study titled "CAR T CELL Therapy for Pediatric, Adolescent and Young Adult Patients With CD19-Positive Leukemia". CAR19PK is a research study evaluating the use of lymphodepleting chemotherapy and chimeric antigen receptor (CAR) T cell therapy, a type of cellular therapy, for the treatment of refractory and/or relapsed leukemia. For this type of therapy, peripheral (circulating) immune cells are collected and t...
What is the current status of trial NCT06847269?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2025-05-21. Estimated completion is 2031-04.
What conditions does trial NCT06847269 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Refractory Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT06847269?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Mesna (DRUG), CD19-CAR T cell Infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT06847269?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06847269 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 Acute Lymphoblastic Leukemia
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 NCT06847269's enrollment target sits among peer trials
25 99th of 131 higher than 32 of 131 other Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Lymphoblastic Leukemia 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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