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ACTIVE NOT RECRUITING
NCT03573700
PHASE1/PHASE2

Evaluation of CD19-Specific CAR Engineered Autologous T-Cells for Treatment of Relapsed/Refractory CD19+ Acute Lymphoblastic Leukemia

Sponsor: St. Jude Children's Research Hospital

View on ClinicalTrials.gov

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.

Official title: SJCAR19: A Phase I/II Study Evaluating SJCAR19 (CD19-Specific CAR Engineered Autologous T-Cells) in Pediatric and Young Adult Patients ≤ 21 Years of Age With Relapsed or Refractory CD19+ Acute Lymphoblastic Leukemia

Key Details

Gender

All

Age Range

Any - 21 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2018-07-24

Completion Date

2026-07-01

Last Updated

2025-11-18

Healthy Volunteers

No

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine

Given IV

DRUG

Mesna

Given IV

DEVICE

CliniMACS

The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest.

BIOLOGICAL

CD19- specific CAR engineered autologous T-cells (SJCAR19 product)

Given IV

Locations (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States