OncoMatch/Clinical Trials/NCT06777979
CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia
Is NCT06777979 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Fludarabine and Cyclophosphamide for acute lymphoblastic leukemia.
Treatment: Fludarabine · Cyclophosphamide · Mesna · CD19-CD22 CAR T cell infusion — This study is a phase I study designed to evaluate the safety of CD19-CD22-CAR T cells. Primary Objective: To determine the safety profile and propose the recommended phase 2 dose (RP2D) of autologous CD19-CD22-CAR T cells in patients ≤ 21 years of age with recurrent/refractory CD19- and/or CD22-positive leukemia. Secondary Objective: To evaluate the anti-leukemic activity of CD19-CD22-CAR T cells.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 positivity
CD19 and/or CD22-positivity confirmed within 2 months and after receipt of any CD19 or CD22-directed therapy
Required: CD22 positivity
CD19 and/or CD22-positivity confirmed within 2 months and after receipt of any CD19 or CD22-directed therapy
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 forced vital capacity (FVC) >50% of predicted value; or pulse oximetry >92% on room air; Total bilirubin < 3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome; Alanine aminotransferase (ALT) or aspartate aminotransferase (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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