Peds CHAMP1ON - Hematopoietic Stem Cell And Monoclonal Antibody PD-1 Blockade for RecurreNt Pediatric High-Grade Glioma

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT07031765
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Ependymoma
  • Grade III Astrocytoma
  • Grade IV Astrocytoma
  • Oligoastrocytoma
  • Oligodendroglioma
  • Recurrent High-grade Glioma

Eligibility Criteria

Sex
ALL
Age
4 Years - 26 Years
Healthy Volunteers
Not accepted

Interventions

  • exHSC — BIOLOGICAL
    Ex vivo expanded CD34+ hematopoietic stem cells (exHSCs) at a targeted dose of 2.5 x 106 cells/kg (or maximal achievable dose, with a minimum deliverable dose of 1/10 target dose; max dose 1.0 x 108 total cells for patients ≥40kg).
  • Nivolumab — DRUG
    Nivolumab 3mg/kg once every 2 weeks, max dose 240mg. Nivolumab will be administered on day 1 and day 15 of each cycle for a total of 10 cycles. Nivolumab may continue for a total two years of therapy, at the discretion of the treating team.
  • Resection or biopsy — PROCEDURE
    Patients must be candidates for standard of care surgical resection or biopsy.

Study Details

This is a Phase I study of ex vivo expanded CD34+ hematopoietic stem cells (exHSCs) plus nivolumab in pediatric patients with histologically confirmed diagnosis of a non-brainstem high-grade glioma (NB-HGG, WHO Grade III or IV astrocytoma, oligodendrogliomas, oligoastrocytomas, ependymomas) that is recurrent, progressive or refractory following radiotherapy with or without chemotherapy. Patients must be candidates for standard of care surgical resection or biopsy.

Key Dates

Start date
Jul 25, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2032

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Adjuvant exHSCs + Nivolumab (starting after surgery/biopsy) (Arm 1)
    Immediate maximal surgical resection or biopsy, untreated tumor. exHSCs and Nivolumab will be administered after maximal surgical resection.
  • Experimental: Neoadjuvant exHSCs + Nivolumab (starting before surgery/biopsy) (Arm 2)
    exHSCs + Nivolumab will be administered prior to maximal surgical resection or biopsy.

Primary Outcome Measure

Rate of DLTs in treated participants [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
UF Health Shands Children's Hospital/Shands HospitalGainesvilleFlorida32608-

Find similar trials in Gainesville, FL

By research site
UF Health Shands Children's Hospital/Shands Hospital· Gainesville, FL

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