UCD19 CAR-T for Pediatric B-ALL and B-NHL
This study is testing a new type of cell therapy called UCD19 CAR-T cells for children and young adults with B-cell Acute Lymphoblastic Leukemia (B-ALL) or B-cell Non-Hodgkin Lymphoma (B-NHL). This therapy uses your own immune cells, called T-lymphocytes, which are specially modified to recognize and fight cancer cells. The study aims to see how safe and tolerable UCD19 CAR-T cells are, and how well they work in treating these cancers. This trial is open to patients aged 31 days to 30 years. The study plans to enroll 45 participants. The current recruitment status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 45 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be measured up to 28 days after UCD19 infusion. Efficacy will be measured at Day 28 for B-ALL and Day 90 for B-NHL after infusion.
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NCT04544592
UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL
Recruiting
PHASE1Ages 31–30InterventionalTreatmentUniversity of Colorado, DenverInvestigator-initiated
~45 participants
Updated 2026-04-20 on ClinicalTrials.gov
What's tested:CD19CAR-CD3Zeta-4-1BB-Expressing Autologous T-Lymphocyte Cells
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the safety and tolerability of UCD19 CAR-T infusion in pediatric patients with B-ALL or B-NHL
Measured over Post UCD19 infusion to Day 28
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesColorado1
Study leadership
- Vanessa Fabrizio, MD, MS · PRINCIPAL_INVESTIGATOR · Children's Hospital Colorado
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Meets clinical criteria for leukapheresis or has a leukapheresis product previously collected and stored per recommended guidelines.
Provision of signed and dated consent form from parent or guardian (patients \<18), the patient themselves (\>18), or legally authorized representative (patient \>18 who lack decision-making capacity); Pediatric patients will be included in age-appropriate discussions and assent will be obtained for those \> 7 years of age, when appropriate, according to institutional standards.
Willingness to participate in long term follow up study.
Stated willingness to comply with all study procedures and be available for the duration of the study.
Males OR non-pregnant, non-breastfeeding females.
Aged 31 days to 30 years (inclusive) at time of consent and enrollment.
Acute Lymphoblastic Leukemia (ALL) OR Non-Hodgkin Lymphoma (NHL) of B-cell origin that:
Has confirmed expression of CD19 by flow cytometry, immunohistochemistry (IHC), or both.
Meets any one of the following conditions:
Relapsed two or more times
Relapsed at any time after allogeneic BMT
Refractory to standard therapy as determined by the treating physician
Meets criteria for BMT but is ineligible as determined by the treating physician Patient and/or parents declining BMT options and would prefer CAR-T Therapy.
Non-Hodgkin Lymphoma includes all of the following:
Diffuse large B-cell lymphoma (DLBCL)
Burkitt Lymphoma
Intermediate lymphoma between Burkitt and DLBCL
Primary Mediastinal B-cell Lymphoma (PMBL)
Follicular lymphoma
High grade B cell lymphoma
Transformed lymphoma
B-ALL in first relapse with any one of the following conditions:
High-risk genomic alterations at initial diagnosis such as KMT2A gene rearrangement, t(17;19), hypodiploidy, Ph-like mutations, BCR-ABL1 fusion (Ph+ ALL), iAMP21, and TP53 inactivating mutation/deletion.
Isolated CNS relapse such that cranial radiation would be indicated as a component of standard salvage therapy.
Down syndrome.
Minimal residual disease (MRD) positivity of \> 0.01% by FACS or \> 0 clonal sequences by NGS in bone marrow post re-induction chemotherapy.
Age 18 years or older. OR Newly diagnosed with persistent MRD ≥ 0.01% by flow cytometry in bone marrow at end of consolidation.
Performance score (Lansky or Karnofsky) of 50% or better;
Unable to or declined to receive commercially available CD19 CAR-T Therapy.
Exclusion
Evidence of rapidly progressive disease without adequate salvage/bridging regimens as determined by the investigator.
Active Graft-versus-Host Disease (GvHD).
Active, uncontrolled, life-threatening infection that at the determination of the treating physician would preclude safe leukapheresis or tolerance of LD chemotherapy, cell infusion, or cytokine release syndrome.
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)
Post-pubertal females that are pregnant, planning to become pregnant, or unwilling to use birth control (includes abstinence) for the study duration.
Known HIV infection, or active Hepatitis B or active Hepatitis C infection.
What this trial measures
- Determine the safety and tolerability of UCD19 CAR-T infusion in pediatric patients with B-ALL or B-NHLPost UCD19 infusion to Day 28
DLTs of UCD19 CAR-T will be assessed at each of the dose levels in a standard 3+3 dose-escalation design with a determination of recommended Phase 2 dose (RP2D).
- Determine the preliminary efficacy of UCD19 CAR-T cells in pediatric patients with B-ALL or B-NHLDay 28 (for B-ALL) and Day 90 (for B-NHL) post UCD19 infusion
Following determination of UCD19 CAR-T RP2D, there will be a cohort expansion to determine preliminary efficacy and biological activity by assessment of CR status.