Actively Recruiting
UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL
Led by University of Colorado, Denver · Updated on 2026-04-20
45
Participants Needed
1
Research Sites
277 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
C
Children's Hospital Colorado
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meets clinical criteria for leukapheresis or has a previously collected leukapheresis product stored per guidelines
- Signed consent form from parent/guardian (patients under 18), patient (18 or older), or legally authorized representative
- Willingness to participate in long-term follow-up
- Willingness to comply with all study procedures and be available for the study duration
- Male or non-pregnant, non-breastfeeding female
- Patients of child-bearing potential must agree to use highly effective contraception from initial CAR-T administration through 12 months after final dose
- Age between 31 days and 30 years at consent and enrollment
- Diagnosis of B-cell acute lymphoblastic leukemia (B-ALL) or B-cell non-Hodgkin lymphoma (B-NHL) with confirmed CD19 expression by flow cytometry or immunohistochemistry
- Cohort One: relapsed two or more times, relapsed after allogeneic bone marrow transplant, refractory to standard therapy, meet criteria for bone marrow transplant but ineligible or declined transplant
- Non-Hodgkin lymphoma subtypes include diffuse large B-cell lymphoma, Burkitt lymphoma, intermediate lymphoma between Burkitt and DLBCL, primary mediastinal B-cell lymphoma, follicular lymphoma, high grade B cell lymphoma, transformed lymphoma
- Cohort Two: B-ALL in first relapse with high-risk genomic alterations, isolated CNS relapse requiring cranial radiation, Down syndrome, minimal residual disease positivity after re-induction chemotherapy, age 18 or older, or newly diagnosed with persistent minimal residual disease at end of consolidation
- Performance score (Lansky or Karnofsky) of 50% or better
- Unable or declined to receive commercially available CD19 CAR-T therapy
You will not qualify if you...
- Rapidly progressive disease without adequate salvage or bridging regimens
- Active graft-versus-host disease (GvHD)
- Active, uncontrolled, life-threatening infection preventing safe leukapheresis or treatment
- Severe organ dysfunction including myocardial dysfunction (ejection fraction ≤ 40% or shortening fraction ≤ 28%), significant pericardial effusion, or abnormal ECG findings
- Baseline oxygen saturation ≤ 90% on room air
- Liver enzymes (transaminases) > 10 times upper limit of normal or bilirubin > 2 times upper limit of normal unless related to primary disease
- Estimated creatinine clearance < 60 mL/min/1.73 m2 unless superseded by more specific testing
- Post-pubertal females who are pregnant, planning pregnancy, or unwilling to use birth control
- Known HIV infection or active hepatitis B or C infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
V
Vanessa Fabrizio, MD, MS
CONTACT
K
Kayla Ortiz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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