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ACTIVE NOT RECRUITING
NCT06254326
PHASE1

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

Sponsor: University of Florida

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

18 Years - 89 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2024-09-19

Completion Date

2028-06

Last Updated

2026-03-09

Healthy Volunteers

No

Interventions

BIOLOGICAL

TTRNA-DC vaccines with GM-CSF

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

BIOLOGICAL

Autologous Hematopoietic Stem cells (HSCs)

Participants will receive a single infusion of autologous CD34+ HSCs

BIOLOGICAL

TTRNA-xALT

Participants will receive a single infusion of ex vivo expanded tumor-reactive T cells

DRUG

Td vaccine

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.

Locations (1)

University of Florida Health Shands Hospital

Gainesville, Florida, United States