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

Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
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• 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

Locations
United States
Florida
University of Florida Health Shands Hospital
RECRUITING
Gainesville
Contact Information
Primary
Phuong Deleyrolle, RN
phuong.deleyrolle@neurosurgery.ufl.edu
352-273-9000
Time Frame
Start Date: 2024-09-19
Estimated Completion Date: 2028-06
Participants
Target number of participants: 12
Treatments
Experimental: Adoptive Cellular Therapy
All participants will receive 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), a single i.v. infusion of ex vivo expanded tumor-reactive T cells, and a i.v. single infusion of autologous HSCs.
Sponsors
Leads: University of Florida
Collaborators: Oligo Nation, Inc

This content was sourced from clinicaltrials.gov