Recruiting
Phase 1
Phase 2

UCD19 CarT

Sponsor:

University of Colorado, Denver

Code:

NCT04544592

Conditions

B-cell Acute Lymphoblastic Leukemia

B-cell Non Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

Interventions

CD19CAR-CD3Zeta-4-1BB-Expressing Autologous T-Lymphocyte Cells

Study Details

Brief summary:

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

B-cell Acute Lymphoblastic Leukemia

B-cell Non Hodgkin Lymphoma

Study ID

NCT04544592

Start date

Mar 10, 2021

Status verified date

Apr, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

o Patients of child-bearing potential or capable of fathering a child must agree to use highly effective contraception from the time of initial CAR T cell administration though 12 months following the final administration of investigational product.
  • 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.

Cohort One Criteria:

  • 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

Cohort Two Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

45 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase I: Dose Escalation

First 4-18 subjects enrolled. Treated with escalating doses of therapy until the recommended phase 2 dose (RP2D) is determined.

experimental: Phase II: Dose Expansion

Up to 18 additional subjects will be treated at the recommended Phase 2 dose (RP2D) to allow for 12 total subjects to be treated in each cohort, including those treated within the phase 1 portion at the RP2D.

Interventions

CD19CAR-CD3Zeta-4-1BB-Expressing Autologous T-Lymphocyte Cells

The CD19 CAR used in this study consists of three main components: the variable regions of the anti-CD19 monoclonal antibody FMC63 71, linked to the TNFRSF-19-derived transmembrane domain, the 4-1BB costimulatory molecule, and the signaling domain of the CD3-zeta molecule. The DNA encoding this receptor was cloned into a lentiviral vector (LV) backbone.

Primary outcome measure

  • Determine the safety and tolerability of UCD19 CAR-T infusion in pediatric patients with B-ALL or B-NHL [ Time Frame: Post UCD19 infusion to Day 28 ]
  • Determine the preliminary efficacy of UCD19 CAR-T cells in pediatric patients with B-ALL or B-NHL [ Time Frame: Day 28 (for B-ALL) and Day 90 (for B-NHL) post UCD19 infusion ]

Central Contacts and Locations

Central contacts

Vanessa Fabrizio, MD, MS

720-777-6860BMT@childrenscolorado.org

Kayla Ortiz

720-777-2564kayla.ortiz@childrenscolorado.org

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Vanessa Fabrizio, MD, MS

720-777-6860BMT@childrenscolorado.org

Principal Investigator:

Vanessa Fabrizio, MD, MS

More Information

Sponsor

University of Colorado, Denver

Last update posted

Apr 20, 2026

Last verified

Apr, 2025

Keywords

  • CD19
  • CAR-T
  • pediatric
  • relapsed
  • refractory
  • B-ALL
  • B-NHL
  • Miltenyi CliniMACS Prodigy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-04-20.