OncoMatch/Clinical Trials/NCT06559189
CD19x22 Chimeric Antigen Receptor T-cell Therapy (CAR T) in Pediatric B-ALL
Is NCT06559189 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies CD19x22 CAR T for b-cell acute lymphoblastic leukemia.
Treatment: CD19x22 CAR T — This study will evaluate the safety and tolerability of administering a novel bispecific CD19/CD22-directed CAR T cell product (CD19x22) for the treatment of relapsed or refractory pediatric B-ALL.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 expression (present)
CD19 and/or CD22 present on last relapsed/refractory disease evaluation
Required: CD22 expression (present)
CD19 and/or CD22 present on last relapsed/refractory disease evaluation
Demographics
Lab requirements
Kidney function
Estimated Creatinine (Cr) clearance < 60 mL/min/1.73 m2 (if nuclear medicine GFR or other more specific testing exceeds this level than it can supersede the estimated clearance)
Liver function
Transaminases > 10x upper limit of normal (ULN) or bilirubin > 5x the ULN, unless thought to be related to primary disease
Cardiac function
Myocardial dysfunction (based on age standards): Ejection fraction ≤ 40% or shortening fraction ≤ 28%, evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and clinically significant electrocardiogram (ECG or EKG) findings
Evidence of severe organ dysfunction defined by: Baseline oxygen saturation of < 90% on room air; Myocardial dysfunction (based on age standards): Ejection fraction ≤ 40% or shortening fraction ≤ 28%, evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and clinically significant electrocardiogram (ECG or EKG) findings; Transaminases > 10x upper limit of normal (ULN) or bilirubin > 5x the ULN, unless thought to be related to primary disease; Estimated Creatinine (Cr) clearance < 60 mL/min/1.73 m2 (if nuclear medicine GFR or other more specific testing exceeds this level than it can supersede the estimated clearance)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital Colorado · Aurora, Colorado
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06559189 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require CD19?
Yes, CD19 expression is a required biomarker for enrollment.
Does this trial require CD22?
Yes, CD22 expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 30 years or younger and at least 0 years old.
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