Phase I Study -To Assess Safety and Feasibility of IL-8 Receptor Modified Patient-derived Activated CD70 CAR T Cell Therapy in CD70+ Adult GBM and Pediatric High-Grade Gliomas (pHGG) (IMPACT)

NCT05353530 Phase 1 ACTIVE_NOT_RECRUITING

This is a phase I study to assess the safety and feasibility of IL-8 receptor modified patient-derived activated CD70 CAR T cell therapy in CD70+ adult glioblastoma

Details

Lead sponsor	University of Florida
Phase	Phase 1
Status	ACTIVE_NOT_RECRUITING
Enrolment	39
Start date	2023-07-25
Completion	2042-12

Conditions

• Glioblastoma Multiforme
• Glioblastoma

Interventions

• Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells

Primary outcomes

• Safety of 8R-70CAR T-cell therapy in adult patients with de novo CD70+ GBM — 28 days post-infusion
  Defined as ≤ 1 DLT out of 6 patients is observed at the 1x10\^8 cells/Kg dose. Dose-Limiting toxicity (DLT) will be defined as any adverse event attributable (possible, probable, or definite) to the administration of 8R-70CAR T cells and occurring from the time of infusion through 28 days post-infusion.
• Feasibility of 8R-70CAR T-cell therapy in adult patients with de novo CD70+ GBM — 10 weeks
  Feasibility will be defined as the ability to infuse 8R-70CAR T-cell safely in 66.7 % of enrolled patients (patients who signed consent and were deemed eligible for the study).

Countries

United States