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 (Jun 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
Treatments studied
Chemotherapy
Other
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
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06847269 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require CD19?
Yes, CD19 positive is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 21 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages