ADAGiO: Adoptive Cellular Therapy for the TreAtment of Recurrent OliGodendrogliOma (OG) Adult Patients

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT06254326
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Progressive Oligodendroglioma
  • Recurrent Oligodendroglioma

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • TTRNA-DC vaccines with GM-CSF — BIOLOGICAL
    Participants will receive up to 9 intradermal DC vaccines (three -bi-weekly (q2 weeks) for priming, monthly for additional 2-3 cycles during T cell expansion, and three bi-weekly during T cell engraftment
  • Autologous Hematopoietic Stem cells (HSCs) — BIOLOGICAL
    Participants will receive a single infusion of autologous CD34+ HSCs
  • TTRNA-xALT — BIOLOGICAL
    Participants will receive a single infusion of ex vivo expanded tumor-reactive T cells
  • Td vaccine — DRUG
    All patients will receive a full Td booster IM vaccine 4-24 hours prior to Vaccine #1 and vaccine site pretreatment with a one-fifth dose of Td intradermally, at the site of planned vaccine, 4-24 hours prior to vaccines #3, #5, #7 and #9.

Study Details

This study will enroll 6 DLT evaluable subjects (up to 12 patients total) where we will evaluate feasibility and safety of adoptive cellular therapy combined with IDH1/2 inhibitors in patients with recurrent or progressive oligodendroglioma WHO grade 2 and WHO grade 3.

Key Dates

Start date
Sep 19, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adoptive Cellular Therapy
    All participants will receive 9 intradermal DC vaccines (three -bi-weekly (q2 weeks) for priming, monthly for additional 2-3 cycles during T cell expansion, and three bi-weekly during T cell engraftment), a single i.v. infusion of ex vivo expanded tumor-reactive T cells, and a i.v. single infusion of autologous HSCs.

Primary Outcome Measure

Prevalence of enrolled subject who receive qualified immunotherapy investigational product. [ Time Frame: enrollment up to 9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Florida Health Shands HospitalGainesvilleFlorida32610
Phuong Deleyrolle
[email protected]
352-273-9000
Ashley Ghiaseddin, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Gainesville, FL

By research site
University of Florida Health Shands Hospital· Gainesville, FL