TX103 / Fuzhou Tcelltech Biotech - LARVOL DELTA

Intracranial delivery of B7-H3-targeting CAR-T cells for recurrent glioblastoma: a phase 1 trial. (PubMed, Nat Med) - P1 | "In conclusion, intracranial TX103 infusion demonstrated acceptable safety and encouraging efficacy in rGBM, supporting a future phase 2 evaluation at the RP2D (DL2, 6 × 107 cells per infusion). ClinicalTrials.gov registration: NCT05241392 ."

Journal • P1 data • Brain Cancer • Cardiovascular • CNS Disorders • Epilepsy • Glioblastoma • Hypertension • Oncology • Solid Tumor

Intrathecal 89Zr-DFO-B7-H3 Immuno-PET/MRI Enables Longitudinal Monitoring of Antigen Modulation During B7-H3 CAR-T Therapy in Orthotopic Glioma (SNMMI 2026) - "IT 89Zr-DFO-B7-H3 immuno-PET/MRI enables longitudinal, semi-quantitative monitoring of intratumoral B7-H3 during B7-H3 CAR-T therapy, supporting both patient selection and on-treatment detection of antigen modulation/escape in orthotopic glioma."

CAR T-Cell Therapy • Brain Cancer • Glioma • Solid Tumor • CD276

Dual-modality imaging enables longitudinal biodistribution profiling of intracerebroventricular CAR-T therapy in orthotopic glioma. (PubMed, Cancer Immunol Immunother) - "Here, we report a dual-modality cell labeling and tracking strategy based on indocyanine green-conjugated iron nanoparticles (ICG-NPs) for in vivo assessment of B7-H3-targeting CAR-T cell (TX103) biodistribution using second near-infrared window (NIR-II) fluorescence imaging and magnetic resonance imaging (MRI)...Furthermore, organ-level NIR-II exposure showed a positive association with CD3⁺ T-cell density across organs (R2 = 0.552, p < 0.001), supported by multi-organ pathological validation. Collectively, we establish a biocompatible dual-modality workflow that links intracranial anatomical localization with longitudinal whole-body biodistribution readouts for preclinical CAR-T tracking in solid tumor models."

IO biomarker • Journal • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor • CXCR3

Phase I Study of TX103 CAR-T Cells in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=85 | Recruiting | Sponsor: Tcelltech Inc.

New P1 trial • Solid Tumor

Tcelltech Secures USD 40 Million Series B Funding for TX-103 CAR-T Therapy Development (flcube.com) - "China-based Tcelltech...has reportedly secured close to USD 40 million in a Series B financing round. The funding was led by CS Capital, with participation from a prominent insurance fund and Lotus Lake Capital. Additional support came from institutions such as China Industrial International Trust Asset Management. The proceeds will be allocated to the clinical development of the company’s core pipeline product, TX-103, in both China and the U.S. The funds will also support the R&D of other pipeline projects, global team expansion, and the acceleration of the company’s international strategic layout and business development (BD) collaborations....TX-103, a B7-H3-targeted CAR-T cell therapy, has entered global regulatory clinical studies for solid tumors, including recurrent glioblastoma (rGBM)."

Financing • Glioblastoma

Effect of 4-1BBL-OX40L fusion protein on the anti-tumor activity of CAR-T cells in solid tumors. (ASCO 2025) - " Both 4-1BBL and the 4-1BBL-OX40L fusion protein significantly enhanced B7-H3 CAR-T cell proliferation and cytotoxicity... These results suggest that co-expressing 4-1BBL-OX40L fusion protein improves anti-tumor activity of B7-H3-targeted CAR-T cells against solid tumors in vitro and in vivo. B7-H3-targeted CAR-T cells co-expressing 4-1BBL-OX40L fusion protein is a promising treatment for solid tumors."

CAR T-Cell Therapy • IO biomarker • Brain Cancer • Colon Cancer • Colorectal Cancer • Glioblastoma • Hematological Malignancies • Oncology • Solid Tumor • CD4 • CD8 • HAVCR2 • IFNG • PD-1 • TIGIT • TNFSF4

Safety and Efficacy Study of Anti-B7-H3 CAR-T Cell Therapy for Recurrent Glioblastoma (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Beijing Tiantan Hospital | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Dec 2026

Enrollment closed • Trial completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD276

Safety and Efficacy Study of TX103 CAR-T Cell Therapy for Recurrent or Progressive Grade 4 Glioma. (clinicaltrials.gov) - P1 | N=52 | Recruiting | Sponsor: Tcelltech Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Jun 2024 ➔ Sep 2024

Enrollment open • Trial initiation date • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Malignant Glioma • Oncology • Solid Tumor • IFNG • IL10 • IL2 • IL6 • TNFA

A Phase I, Open-Label, Single/Multiple Dose, Dose-escalation Study to Evaluate the Safety, Tolerability and Antitumor Activity of TX103 CAR-T Cell Injection (TX103) in Subjects with Recurrent or Progressive Grade 4 Glioma. (ChiCTR) - P1 | N=39 | Not yet recruiting | Sponsor: Tiantan Hospital, Beijing, China; Fuzhou Tcelltech Biological Science and Technology Inc.

New P1 trial • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor • BRAF • CD276 • NTRK

Safety and Efficacy Study of TX103 CAR-T Cell Therapy for Recurrent or Progressive Grade 4 Glioma. (clinicaltrials.gov) - P1 | N=52 | Not yet recruiting | Sponsor: Tcelltech Inc.

CAR T-Cell Therapy • New P1 trial • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor • IFNG • IL10 • IL2 • IL6 • TNFA

Orphan Designation: Treatment of Malignant Glioma (FDA) - Date Designated: 06/21/2023

Orphan drug • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor