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

NCT06254326 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-05-27

No results posted yet for this study

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.

Conditions

  • Recurrent Oligodendroglioma
  • Progressive Oligodendroglioma

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.

Sponsors & Collaborators

  • Oligo Nation, Inc

    collaborator UNKNOWN

  • University of Florida

    lead OTHER

Principal Investigators

  • Duane Mitchell, MD, PhD · University of Florida

  • Ashley Ghiaseddin, MD · University of Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-19
Primary Completion
2027-12-31
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06254326 on ClinicalTrials.gov