Recruiting
Phase 1

Adoptive Cellular Therapy & IDH1/2 Inhibitors

Sponsor:

University of Florida

Code:

NCT06254326

Conditions

Recurrent Oligodendroglioma

Progressive Oligodendroglioma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

TTRNA-DC vaccines with GM-CSF

Autologous Hematopoietic Stem cells (HSCs)

TTRNA-xALT

Td vaccine

Study Details

Brief 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

Study ID

NCT06254326

Start date

Sep 19, 2024

Status verified date

Dec, 2025

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or female, aged 18 years and above
  • Tumor tissue obtained on a screening consent is available.
  • Confirmed with recurrent/progressive IDH-mutant 1p/19q co-deleted Oligodendroglioma WHO grade 2 or WHO grade 3, more than 12 weeks from completion of radiation.
  • Karnofsky Performance Status ≥ 60
  • Must be a candidate for surgery/biopsy
  • Adequate bone marrow and organ function as defined below:

  • ANC ≥ 1,000/mcL
  • Platelets ≥ 100,000/mcL
  • Hemoglobin ≥ 9 g/dL (can be transfused)
  • Serum creatinine ≤ 1.5 x IULN OR Creatinine clearance by Cockcroft-Gault ≥ 60 mL/min for patients with serum creatinine > 1.5 x IULN
  • Serum total bilirubin ≤ 1.5 x IULN OR Direct bilirubin ≤ IULN for patients with total bilirubin > 1.5 x IULN
  • AST (SGOT) and ALT (SGPT) ≤ 3 x IULN
  • For females of childbearing potential, negative serum pregnancy test at enrollment
  • For women and men of childbearing potential (WOCBP) must be willing to use acceptable contraceptive methods

Exclusion Criteria:

  • Disease progression during treatment with an anti-IDH-1 or anti IDH-2
  • Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years.
  • Metastases detected below the tentorium or beyond the cranial vault and leptomeningeal involvement.
  • Multifocal disease.
  • Corticosteroids equivalent to ≥ 4mg dexamethasone daily.
  • HIV, Hepatitis B, or Hepatitis C seropositive.
  • Known active infection or immunosuppressive disease.
  • Autoimmune disease requiring medical management with immunosuppressant.
  • Pregnancy or lactation, due to possible adverse effects on the developing fetus or infant.
  • Treatment with another investigational drug or other intervention within 30 days prior to projected first dose of study treatment (Priming phase with TTRNA-DC).
  • Severe, active co-morbidity, defined as follows:

  • Unstable angina and/or congestive heart failure requiring hospitalization.
  • Transmural myocardial infarction within the last 6 months.
  • Acute bacterial or fungal infection requiring intravenous antibiotics at time of enrollment.
  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy.
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
  • Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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

Autologous Hematopoietic Stem cells (HSCs)

Participants will receive a single infusion of autologous CD34+ HSCs

TTRNA-xALT

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

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.

Primary outcome measure

  • Prevalence of enrolled subject who receive qualified immunotherapy investigational product. [ Time Frame: enrollment up to 9 months ]
  • Incidence of investigational treatment related severe toxicity (Dose-limiting toxicity event) assessed during the period beginning with administration of ex vivo expanded TTRNA T cells through 6 weeks post infusion. [ Time Frame: enrollment to completion of DLT window; up to 9 months. ]

Central Contacts and Locations

Central contacts

Phuong Deleyrolle, RN

352-273-9000phuong.deleyrolle@neurosurgery.ufl.edu

Locations

University of Florida Health Shands Hospital

Recruiting

Gainesville, Florida, United States, 32610

Contacts

352-273-9000phuong.deleyrolle@neurosurgery.ufl.edu

Principal Investigator:

Ashley Ghiaseddin, MD

More Information

Sponsor

University of Florida

Last update posted

May 27, 2026

Last verified

Dec, 2025

Keywords

  • Immunotherapy
  • Brain Tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-05-27.