OncoMatch/Clinical Trials/NCT06847269
CAR T CELL Therapy for Pediatric, Adolescent and Young Adult Patients With CD19-Positive Leukemia
Is NCT06847269 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including CD19-CAR T cell Infusion and Fludarabine for acute lymphoblastic leukemia.
Treatment: Fludarabine · Cyclophosphamide · Mesna · CD19-CAR T cell Infusion — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 positive (CD19+)
must be confirmed to be CD19+ within 3 months prior to enrollment for treatment
Lab requirements
Kidney function
creatinine clearance or radioisotope GFR ≥ 50 ml/min/1.73m2 (GFR ≥ 40 ml/min/1.73m2 if < 2 years of age)
Liver function
Total Bilirubin ≤ 3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome; ALT or AST ≤ 5 times the upper limit of normal for age
Cardiac function
left ventricular ejection fraction > 40%, or shortening fraction ≥ 25%; EKG without evidence of clinically significant arrhythmia
Adequate cardiac function defined as left ventricular ejection fraction > 40%, or shortening fraction ≥ 25%; EKG without evidence of clinically significant arrhythmia; Adequate renal function defined as creatinine clearance or radioisotope GFR ≥ 50 ml/min/1.73m2 (GFR ≥ 40 ml/min/1.73m2 if < 2 years of age); Adequate pulmonary function defined as FVC ≥ 50% of predicted value; or pulse oximetry ≥ 92% on room air if patient is unable to perform pulmonary function testing; Total Bilirubin ≤ 3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome; ALT or AST ≤ 5 times the upper limit of normal for age
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- St. Jude Children's Research Hospital · Memphis, Tennessee
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