ADAGiO: Adoptive Cellular Therapy for the TreAtment of Recurrent OliGodendrogliOma (OG) Adult Pat… (NCT06254326) | Clinical Trial Compass
Active — Not RecruitingPhase 1
ADAGiO: Adoptive Cellular Therapy for the TreAtment of Recurrent OliGodendrogliOma (OG) Adult Patients
United States12 participantsStarted 2024-09-19
Plain-language 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.
Who can participate
Age range18 Years – 89 Years
SexALL
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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.
* Autoimm…
What they're measuring
1
Prevalence of enrolled subject who receive qualified immunotherapy investigational product.
Timeframe: enrollment up to 9 months
2
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.
Timeframe: enrollment to completion of DLT window; up to 9 months.