ADAGiO: Adoptive Cellular Therapy for the TreAtment of Recurrent OliGodendrogliOma (OG) Adult Patients
University of Florida
12 participants
Sep 19, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria14
- 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 Criteria18
- 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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Interventions
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
Participants will receive a single infusion of autologous CD34+ HSCs
Participants will receive a single infusion of ex vivo expanded tumor-reactive T cells
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06254326