OncoMatch/Clinical Trials/NCT04544592
UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL
Is NCT04544592 recruiting? Yes, currently enrolling (May 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
Cancer type
Acute Lymphoblastic Leukemia
Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 expression (confirmed expression by flow cytometry, immunohistochemistry (IHC), or both)
Has confirmed expression of CD19 by flow cytometry, immunohistochemistry (IHC), or both
Allowed: KMT2A (MLL) rearrangement
High-risk genomic alterations at initial diagnosis such as KMT2A gene rearrangement
Allowed: BCR BCR-ABL1 fusion
High-risk genomic alterations at initial diagnosis such as ... BCR-ABL1 fusion (Ph+ ALL)
Allowed: TP53 inactivating mutation/deletion
High-risk genomic alterations at initial diagnosis such as ... TP53 inactivating mutation/deletion
Prior therapy
Must have received: allogeneic bone marrow transplant
Relapsed at any time after allogeneic BMT
Cannot have received: gene therapy
Prior gene therapy, including prior CAR-T cell
Cannot have received: CAR-T cell therapy
Prior gene therapy, including prior CAR-T cell
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. Baseline oxygen saturation of ≤ 90% on room air
Evidence of severe organ dysfunction as defined by: 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. Baseline oxygen saturation of ≤ 90% on room air. Transaminases > 10x upper limit of normal (ULN) or bilirubin >2x the ULN, unless thought to be related to primary disease. 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)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital Colorado · Aurora, Colorado
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