OncoMatch/Clinical Trials/NCT04544592
UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL
Is NCT04544592 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies CD19CAR-CD3Zeta-4-1BB-Expressing Autologous T-Lymphocyte Cells for b-cell acute lymphoblastic leukemia.
Treatment: CD19CAR-CD3Zeta-4-1BB-Expressing Autologous T-Lymphocyte Cells — This phase I/II trial will investigate a new CD19 directed CAR-T therapy manufactured locally with the goals to expedite infusion to wider patient inclusion that includes those who were previously excluded, such as pediatric patients with B-cell NHL and patients in primary relapse.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Required: ABL1 bcr-abl1 fusion
Required: CD19 expression
Required: KMT2A (MLL) rearrangement
Required: TP53 inactivating mutation/deletion
Demographics
Lab requirements
Kidney function
estimated 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 >2x the uln, unless thought to be related to primary disease
Cardiac function
myocardial dysfunction: ejection fraction ≤ 40% or shortening fraction ≤ 28%, evidence of physiologically significant pericardial effusion as determined by an echocardiogram (echo), and clinically significant electrocardiogram (ecg) findings
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 NCT04544592 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require ABL1?
Yes, ABL1 bcr-abl1 fusion is a required biomarker for enrollment.
Does this trial require CD19?
Yes, CD19 expression is a required biomarker for enrollment.
Does this trial require KMT2A?
Yes, KMT2A rearrangement 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 qualify