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ADAGiO: Adoptive Cellular Therapy for Recurrent Oligodendroglioma

This study, called ADAGiO, is testing a new approach for adults with recurrent or progressive oligodendroglioma (a type of brain tumor) that has a specific genetic change (IDH-mutant 1p/19q co-deleted). You might be able to join if you are 18 or older and have this type of tumor. The study will look at the safety and feasibility of a treatment that uses your own immune cells. This involves several steps: receiving TTRNA-DC vaccines (a type of vaccine made from your own cells and tumor material), a single infusion of your own stem cells (Autologous Hematopoietic Stem cells), and a single infusion of specially grown tumor-fighting T cells (TTRNA-xALT). You will also receive a Td vaccine booster. Researchers will be watching closely for any serious side effects and to see if the treatment can be successfully given to participants. Up to 12 patients are planned to enroll.

Study design
This is an interventional study with a planned enrollment of 12 participants. The study aims to evaluate the feasibility and safety of the treatment.
What's involved
You would undergo a biopsy or surgery, then have cells collected for vaccine and T-cell production. This involves receiving multiple vaccines and infusions, along with salvage chemotherapy.
Compensation
Not stated in the trial record.
Follow-up
The study will assess side effects for up to 6 weeks after the TTRNA T cell infusion, and overall product delivery up to 9 months after enrollment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06254326

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

Recruiting
PHASE1Ages 18–89InterventionalTreatment
University of Florida
~12 participants
Updated 2026-05-27 on ClinicalTrials.gov
What's tested:TTRNA-DC vaccines with GM-CSFAutologous Hematopoietic Stem cells (HSCs)TTRNA-xALTTd vaccine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prevalence of enrolled subject who receive qualified immunotherapy investigational product.
Measured over enrollment up to 9 months
+1 more outcome measured

Conditions

Recurrent Oligodendroglioma
Progressive Oligodendroglioma

Explore related trials

Oligodendroglioma1pIDH1 wt Allele

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Duane Mitchell, MD, PhD · STUDY_CHAIR · University of Florida
  • Ashley Ghiaseddin, MD · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Phuong Deleyrolle, RN
[email protected]
352-273-9000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Prevalence of enrolled subject who receive qualified immunotherapy investigational product.enrollment up to 9 months

    Feasibility will be measured by the number of patients who receive autologous dendritic cells, T cells and hematopoietic stem cells that meet the FDA IND defined quality assurance and quality control release criteria. A minimum of 66.7% of enrolled subject must achieve this criterion for feasibility endpoint.

  • 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.enrollment to completion of DLT window; up to 9 months.

    Safety will be defined as \< 1 DLT out of six enrolled and treated subjects during the defined period of administration of ex vivo expanded TTRNA T cells through 6 weeks post infusion. Investigational treatment related CTCAE V5.0 adverse events 1) Grade III or greater non-neurologic toxicity; 2) Grade III neurologic toxicity that does not improve to Grade II or better within 5 days; or 3) Grade IV neurologic toxicity will be recorded toward DLT.