TmEGFR/IL13Rα2 01 CAR-T / University of Pennsylvania, Gilead - LARVOL DELTA

A phase 1 study of intracerebroventricular (ICV) delivery of bivalent chimeric antigen receptor (CAR) T-cells targeting EGFR and IL13Ra2 in patients with recurrent glioblastoma (rGBM). (ASCO 2025) - P1 | "ICV delivery of CART-EGFR-IL13Rα2 is feasible and appears safe. CART-EGFR-IL13Rα2 cells are bioactive and exhibit an encouraging early efficacy signal in rGBM."

Clinical • P1 data • Brain Cancer • CNS Tumor • Fatigue • Glioblastoma • Oncology • Solid Tumor • CD8 • EGFR • IL13RA2 • MGMT

Gilead’s CAR-T cell therapy shows promise in deadly brain cancer (Reuters) - "A Gilead Sciences-backed therapy made with a patient's own white blood cells shrank tumors in 62% of patients with recurrent glioblastoma...The current study now includes 18 patients treated with the experimental therapy after their tumors returned following standard treatment...Of these, only 13 had a measurable tumor at the time the cells were introduced, and of those, eight, or 62%, had their tumors shrink...Several patients lived 12 months or longer, and in one patient, the disease remained stable for 16 months. But so far, the benefit is largely temporary, with many patients relapsing two to three months later...Most patients experienced fevers and neurotoxicity such as lethargy or confusion for two or three days after the cells are injected, but the side effects were manageable..."

Clinical data • Glioblastoma

Dual-target CAR-T Cell Therapy Slows Glioblastoma Tumors in Phase I Trial (Genengnews) - P1 | N=21 | NCT05168423 | "The study enrolled 18 patients with recurrent GBM who underwent surgery to remove as much of the tumor as possible, followed by infusion of the dual-target CAR-T cell therapy directly into the cerebrospinal fluid. The tumors became smaller after CAR-T cell therapy in eight of the 13 patients who still had at least 1 cm of tumor remaining after surgery....Several patients lived 12 months or longer after receiving the investigational therapy, a notable result given that the typical survival prognosis for this patient population is less than a year. Two patients remain alive with stable disease that has continued beyond six months. Additionally, seven patients were still alive after a year, with one individual experiencing no tumor growth for more than 16 months, despite advanced disease spread and rapid growth at the time of enrollment."

P1 data • Glioblastoma

Penn Medicine at the 2025 ASCO Annual Meeting (Newswise) - "Researchers from the Abramson Cancer Center (ACC) of the University of Pennsylvania and Penn’s Perelman School of Medicine will present data on the latest advances in cancer science and medicine at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting...Penn Medicine researchers will present several updates in clinical research, including new Phase I clinical trial data on CAR T cell therapy for glioblastoma, five-year follow-up data on belzutifan for von Hippel-Lindau (VHL) disease, and Phase II clinical data on immunotherapy before surgery in early-stage melanoma. "

Clinical data • Clear Cell Renal Cell Carcinoma • Glioblastoma • Melanoma • Pancreatic Cancer • Von Hippel-Lindau Syndrome

Gilead and Kite Announce Presentation of Transformative Data in 1L Metastatic Triple-Negative Breast Cancer…and Early Data From Novel Investigational CAR T-Cell Therapy Targeting Brain Cancer at 2025 ASCO… (Businesswire) - "At ASCO, Gilead will present detailed late-breaking results from the Phase 3 ASCENT-04 study showing a statistically significant and clinically meaningful benefit in progression-free survival for Trodelvy plus Keytruda versus Keytruda and standard of care chemotherapy in patients with inoperable (unresectable) locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 (Abstract #LBA109). Additionally, Kite research collaborators at the University of Pennsylvania Perelman School of Medicine will present Phase 1 results evaluating a novel investigational CAR T-cell therapy using a dual-target approach in patients with recurrent glioblastoma during an oral session at ASCO (Abstract #102)."

P1 data • P3 data • Glioblastoma • Triple Negative Breast Cancer

Intrathecal bivalent CAR T cells targeting EGFR and IL13Rα2 in recurrent glioblastoma: phase 1 trial interim results (Nature) - P1 | N=18 | NCT05168423 | "One patient in dose level 2 experienced a dose-limiting toxicity (grade 3 anorexia, generalized muscle weakness and fatigue). Reductions in enhancement and tumor size at early magnetic resonance imaging timepoints were observed in all six patients; however, none met criteria for ORR. In exploratory endpoint analyses, substantial CAR T cell abundance and cytokine release in the cerebrospinal fluid were detected in all six patients."

P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology

CART-EGFR-IL13Ra2 in EGFR Amplified Recurrent GBM (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: University of Pennsylvania | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • EGFR

CART-EGFR-IL13Ra2 in EGFR Amplified Recurrent GBM (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: University of Pennsylvania | Initiation date: Jun 2022 ➔ Mar 2023

Trial initiation date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • EGFR

CART-EGFR-IL13Ra2 in EGFR Amplified Recurrent GBM (clinicaltrials.gov) - P1; N=18; Not yet recruiting; Sponsor: University of Pennsylvania; Initiation date: Dec 2021 ➔ Jun 2022

Clinical • Trial initiation date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • EGFR

CART-EGFR-IL13Ra2 in EGFR Amplified Recurrent GBM (clinicaltrials.gov) - P1; N=18; Not yet recruiting; Sponsor: University of Pennsylvania

Clinical • New P1 trial • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • EGFR