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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 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. The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03573700
The ClinicalTrials.gov registry entry for NCT03573700 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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