8R-70CAR T / University of Florida - LARVOL DELTA

IMPACT: IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ Pediatric High-grade Glioma (HGG) (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: University of Florida | Initiation date: Sep 2025 ➔ Mar 2025

Trial initiation date • Brain Cancer • Glioma • High Grade Glioma • Oncology • Pediatrics • Solid Tumor

IMPACT: IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ Pediatric High-grade Glioma (HGG) (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: University of Florida

New P1 trial • Brain Cancer • CNS Tumor • Glioma • Malignant Glioma • Oncology • Pediatrics • Solid Tumor

IMPACT: IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ Adult Glioblastoma (clinicaltrials.gov) - P1 | N=39 | Recruiting | Sponsor: University of Florida | N=18 ➔ 39

Enrollment change • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Malignant Glioma • Oncology • Pediatrics • Solid Tumor • CD70 • MGMT

First-in-Human Phase I Clinical Trial Using 8R-70CAR T Cells for Newly Diagnosed Adult Glioblastoma (SNO 2024) - P1 | "The remaining patient is under SOC therapy before receiving CAR T cell treatment. ConclusionsThis study aims to address current therapeutic gaps and offers options for implementing a novel CAR design for the development of a more effective therapeutic modality for GBM."

CAR T-Cell Therapy • Clinical • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD27 • CD70 • CXCL8

CD70 CXCR2-Modified CAR T-Cells Against Acute Myeloid Leukemia (TCT-ASTCT-CIBMTR 2024) - P1 | "8R-70CAR T cells are able to specifically recognize and kill CD70+ AML cells, and cytotoxicity may be augmented by enhancing CD70 expression with azacytidine pre-treatment. A LLS tumoroid model can aid in 3D visualization of 8R-70CAR T cells interactions AML cells. These findings combined with safety data obtained from our ongoing phase I clinical trial for adults with glioblastoma (NCT05353530) will support expansion of our existing IND to treat patients with AML using our novel 8R-70CAR."

CAR T-Cell Therapy • Acute Myelogenous Leukemia • Brain Cancer • CNS Tumor • Glioblastoma • Hematological Malignancies • Leukemia • Oncology • Solid Tumor • CD70 • CXCL8 • CXCR2 • IFNG

CAR T cell production expands endogenous T cell repertoire recognizing additional tumor antigen(s) (SITC 2023) - P1 | "3 These findings culminated in a phase-I trial of 8R-70CAR T cells (NCT05353530) for patients with newly diagnosed GBM that will begin at UF soon...Conclusions The CAR T cell production process significantly expands pp65-specific T cells, resulting in enhanced antitumor efficacy through recognition of both tumor targets. Our CAR T cell product may contain T cell repertoires that effectively target multiple tumor antigens."

CAR T-Cell Therapy • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor • CD70 • CD8 • CXCL8 • IFNG

Phase I Study of IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ and MGMT-unmethylated Adult Glioblastoma (IMPACT) (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: University of Florida | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2041 ➔ Dec 2042 | Trial primary completion date: Dec 2026 ➔ Dec 2027

CAR T-Cell Therapy • Enrollment open • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD70 • MGMT

Phase I Study of IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ and MGMT-unmethylated Adult Glioblastoma (IMPACT) (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: University of Florida | Trial completion date: Dec 2040 ➔ Dec 2041 | Trial primary completion date: Dec 2025 ➔ Dec 2026

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD70 • MGMT

Phase I Study of IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ and MGMT-unmethylated Adult Glioblastoma (IMPACT) (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: University of Florida | Initiation date: Jun 2022 ➔ Oct 2022

Trial initiation date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • CD70 • MGMT

IMPACT: Phase I Study of CD70 CAR T Cell Therapy in CD70+ and MGMT-unmethylated Adult GBM (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: University of Florida

CAR T-Cell Therapy • New P1 trial • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • CD70 • MGMT