RecruitingPhase 2NCT06847269

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

CAR T CELL Therapy for Pediatric, Adolescent and Young Adult Patients With CD19-Positive Leukemia: An Investigation of Lymphodepleting Chemotherapy Pharmacokinetics


Sponsor

St. Jude Children's Research Hospital

Enrollment

25 participants

Start Date

May 21, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing CAR T-cell therapy — a treatment where a patient's own immune cells are genetically engineered to attack cancer cells — for children, teenagers, and young adults with a type of leukemia (blood cancer) that carries a marker called CD19. **You may be eligible if...** - You are 21 years old or younger - You have CD19-positive leukemia that has come back, stopped responding to treatment, or relapsed after a bone marrow transplant - You are in at least your second relapse, or your first relapse if a bone marrow transplant is not a suitable option for you - You are in reasonably good physical condition (able to care for yourself with some assistance) **You may NOT be eligible if...** - You have a known primary immune deficiency - You have HIV infection - You have a severe active infection (bacterial, viral, or fungal) - You are pregnant or breastfeeding - You have had a severe allergic reaction to mouse-derived protein products Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFludarabine

Given IV

DRUGCyclophosphamide

Given IV

DRUGMesna

Given IV

BIOLOGICALCD19-CAR T cell Infusion

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


Locations(1)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT06847269


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