UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT04544592
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • B-cell Acute Lymphoblastic Leukemia
  • B-cell Non Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
31 Days - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • CD19CAR-CD3Zeta-4-1BB-Expressing Autologous T-Lymphocyte Cells — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 10, 2021
Status verified
Apr 2025
Primary completion
Jun 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045
Vanessa Fabrizio, MD, MS
[email protected]
720-777-6860
Vanessa Fabrizio, MD, MS (PRINCIPAL_INVESTIGATOR)

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By research site
Children's Hospital Colorado· Aurora, CO

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