New cell therapy trial hopes to tackle recurrent brain cancer
NCT ID NCT06254326
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial is testing a personalized cell therapy for adults with recurrent oligodendroglioma, a type of brain tumor. The treatment involves taking a patient's own immune cells and stem cells, modifying them in the lab, and giving them back to fight the tumor. The main goals are to see if this approach is safe and feasible, with only 12 participants planned.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- personalized cell therapy (dendritic cell vaccines, tumor-reactive T cells, and stem cells)
- What this could lead to
- If successful, this could point toward a new treatment option for recurrent oligodendroglioma, a type of brain tumor that is hard to treat.
- What could go wrong
- This is a very early Phase 1 trial with only 12 participants, so it is primarily testing safety and feasibility. The treatment is complex and may cause severe side effects, and it is not yet known if it will help control the tumor.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 89 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Florida Health Shands Hospital
RECRUITINGGainesville, Florida, 32610, United States
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