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