At a glance
ClinicalIndex Comparison RecordPhase 1Recruiting· 39 target
Drug / intervention
Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cellsbiological
Likely dose
Not stated in record
Key inclusion· 19
- ✓Age 18 years or older
- ✓Newly-diagnosed de novo GBM without prior brain tumor history
- ✓Confirmed by histopathology or molecular studies
- ✓Supratentorial tumor component required
Key exclusion· 16
- ✕Prior invasive malignancy unless disease-free ≥3 years (non-melanomatous skin cancer and in situ cancer permitted)
- ✕Metastases below tentorium or beyond cranial vault
- ✕Leptomeningeal disease beyond cranial vault (focal and adjacent involvement allowed)
- ✕Recurrent or multifocal malignant gliomas
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 1 clinical trial evaluating Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells for Glioblastoma Multiforme and Glioblastoma. Currently recruiting, targeting 39 participants across 1 site.
Detailed Summary
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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioblastoma Multiforme, Glioblastoma
CountriesUnited States
CollaboratorsAM Rosen Foundation
Timeline
Phase 1Recruiting
2022202320242025202620272028202920302031203220332034203520362037203820392040204120422043
First PostedApr 2022
Enrollment StartJul 2023
TodayJul 2026
Primary CompletionDec 2027
Study CompletionDec 2042
First PostedApr 29, 2022
Enrollment StartJul 25, 2023
Primary CompletionDec 1, 2027
Study CompletionDec 1, 2042
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 4.2 years agoPrimary completion in 1.4 years
Interventions
Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cellsbiological
Single dose of 8R-70CAR T cells administered IV