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CAR T CELL Therapy for Pediatric, Adolescent and Young Adult Patients With CD19-Positive Leukemia

NCT06847269 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-03-25

No results posted yet for this 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.

Conditions

Interventions

DRUG

Fludarabine

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Mesna

Given IV

BIOLOGICAL

CD19-CAR T cell Infusion

Patients will receive the CD19-CAR T cells by vein, through either an IV or a central line.

Sponsors & Collaborators

Principal Investigators

  • Aimee Talleur, MD · St. Jude Children's Research Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-21
Primary Completion
2030-03-31
Completion
2031-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06847269 on ClinicalTrials.gov