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NCT03573700 · ClinicalTrials.gov registry record · Phase 1
Evaluation of CD19-Specific CAR Engineered Autologous T-Cells for Treatment of Relapsed/Refractory CD19+ Acute Lymphoblastic Leukemia
A Phase 1 study of Acute Lymphoblastic Leukemia, in Relapse and Acute Lymphoblastic Leukemia, Refractory, sponsored by St. Jude Children's Research Hospital.
- Active
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT03573700: Active Phase 1 study of Acute Lymphoblastic Leukemia, in Relapse and Acute Lymphoblastic Leukemia, Refractory, sponsored by St. Jude Children's Research Hospital.
NCT03573700 is a Phase 1 study of Acute Lymphoblastic Leukemia, in Relapse and Acute Lymphoblastic Leukemia, Refractory that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03573700, a Phase 1 study of Acute Lymphoblastic Leukemia, in Relapse and Acute Lymphoblastic Leukemia, Refractory, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
SJCAR19 is a research study seeking to evaluate the use of chimeric antigen receptor (CAR) T cell therapy, a type of cellular therapy, for the treatment of pediatric, adolescent and young adult patients with relapsed or refractory CD19+ acute lymphoblastic leukemia (ALL). CAR therapy combines two of the body's basic disease fighters: antibodies and T Cells. For this type of therapy, peripheral (circulating) immune cells are collected and then undergo a manufacturing process to engineer them to more effectively kill cancer cells. The SJCAR19 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: 1. The largest dose of SJCAR19 that is safe to give, 2. How long SJCAR19 cells last in the body, 3. The side effects of SJCAR19, and 4. Whether or not treatment with SJCAR19 is effective in treating people with refractory or relapsed ALL.
Primary Outcome
The primary objectives for the Phase I study portion are to determine the maximum tolerated dose (MTD) and characterize the safety profile and dose-limiting toxicities (DLTs) of treatment with SJCAR19 in pediatric and young adult patient's ≤ 21 years of age, with relapsed or refractory CD19+ ALL. The proportion of participants with dose limiting toxicities are reported.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Mesna
- DEVICE CliniMACS
- BIOLOGICAL CD19- specific CAR engineered autologous T-cells (SJCAR19 product)
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-07-24 |
| Est. Completion | 2026-07-01 |
| Phase | Phase 1 |
What the registry record for NCT03573700 still lists
NCT03573700 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 2 conditions, with Acute Lymphoblastic Leukemia, in Relapse appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03573700 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT03573700 about?
NCT03573700 is a clinical study titled "Evaluation of CD19-Specific CAR Engineered Autologous T-Cells for Treatment of Relapsed/Refractory CD19+ Acute Lymphoblastic Leukemia". SJCAR19 is a research study seeking to evaluate the use of chimeric antigen receptor (CAR) T cell therapy, a type of cellular therapy, for the treatment of pediatric, adolescent and young adult patients with relapsed or refractory CD19+ acute lymphoblastic leukemia (ALL). CAR therapy combines two of...
What is the current status of trial NCT03573700?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2018-07-24. Estimated completion is 2026-07-01.
What conditions does trial NCT03573700 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, in Relapse, Acute Lymphoblastic Leukemia, Refractory.
What interventions are being tested in trial NCT03573700?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Mesna (DRUG), CliniMACS (DEVICE), CD19- specific CAR engineered autologous T-cells (SJCAR19 product) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03573700?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03573700 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 NCT03573700's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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