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New treatment option for Recurrent Oligodendroglioma
Official title ADAGiO: Adoptive Cellular Therapy for the TreAtment of Recurrent OliGodendrogliOma (OG) Adult Patients
ClinicalTrials.gov ID: NCT06254326
What this study is testing
What is TTRNA-DC vaccines with GM-CSF?
TTRNA-DC vaccines with GM-CSF is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for recurrent oligodendroglioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89
You may be able to join if
- 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...
- Karnofsky Performance Status ≥ 60
- Must be a candidate for surgery/biopsy
You likely can't join if
- 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.
See the full eligibility 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
- 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...
- Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.