CT0180 / CARsgen - LARVOL DELTA

In-depth plasma proteomics reveals the dynamic changes and prognostic biomarkers for chimeric antigen receptor-glypican-3 T-cell therapy in patients with hepatocellular carcinoma. (PubMed, Gastroenterol Rep (Oxf)) - "In addition, plasma proteins were significantly associated with survival outcomes, whereas no significant association was observed between clinical variables and prognosis. Plasma proteomics not only captured CAR-GPC3-driven plasma microenvironment remodeling but also identified baseline proteins predictive of CB and survival, which were superior to clinical variables, thus constituting a candidate biomarker panel for HCC patient selection and response monitoring."

Biomarker • IO biomarker • Journal • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3 • TNFA

CT0180-CG1203: Phase I Clinical Trial of CT0180 Cells in the Treatment of Hepatocellular Carcinoma (clinicaltrials.gov) - P1 | N=21 | Active, not recruiting | Sponsor: Zhejiang University | Trial completion date: Jun 2024 ➔ Jun 2026 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial completion date • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3 • PD-1 • PD-L1

CARsgen Successfully Defends Its GPC3 CAR-T Patent at the EPO (PRNewswire) - "CARsgen Therapeutics...announces a favorable outcome in opposition proceedings before the European Patent Office (EPO) concerning its European patent EP3445407, which covers its GPC3-targeted CAR-T cell therapy. On July 3, 2025, a U.S.-based biotechnology - the sole appellant among the original two opponents - formally withdrew its appeal against the EPO Opposition Division's earlier decision to maintain the patent....The patent was granted by the EPO in 2022 and opposed by two parties in 2023. Following oral proceedings, the EPO Opposition Division issued a decision to maintain the patent in amended form, upholding key claims related to the use of GPC3 CAR-T cell therapy following cyclophosphamide and fludarabine lymphodepletion pretreatment, in the treatment of liver cancer, lung cancer, ovarian cancer, breast cancer, gastric cancer, and thyroid cancer."

Patent • Breast Cancer • Gastric Cancer • Hepatocellular Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Thyroid Gland Carcinoma

CARsgen's CAR-GPC3 T-cell Therapy for Advanced Hepatocellular Carcinoma: Two Patients Achieved over 7 Years of Disease-free Survival (PRNewswire) - P1 | N=13 | NCT02395250 | "...the two patients returned to Renji Hospital for a follow-up examination, which confirmed the absence of tumor recurrence....Patient 1, upon confirmed diagnosis of liver cancer, underwent two rounds of interventional therapy and one session of microwave ablation...Six months later, tumor biomarkers AFP returned to normal, and imaging showed no evident active tumors. To date, the patient has remained tumor-free for over 8 years (July 2015 to August 2023)...Patient 2, following liver cancer resection, experienced intrahepatic tumor recurrence....Through localized treatments (microwave ablation and gamma knife) addressing intrahepatic tumors, the inferior vena cava tumor thrombus, and peritoneal lymph node metastases, combined with CAR T-cell therapy, the patient has currently achieved over 7 years of tumor-free survival (July 2016 to August 2023)."

P1 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

RUNX-3-expressing CAR T cells targeting glypican-3 in patients with heavily pretreated advanced hepatocellular carcinoma: a phase I trial. (PubMed, EClinicalMedicine) - P1 | "CT017 CAR T cells were engineered to co-express CAR-GPC3 and runt-related transcription factor 3 (RUNX3), which triggers CD8 T-cell infiltration into the cancer microenvironment...These results need to be confirmed in a robust clinical trial. This study was funded by CARsgen Therapeutics Co., Ltd."

CAR T-Cell Therapy • Journal • Metastases • P1 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • CD8 • GPC3 • RUNX3 • TCF3

Combined local therapy and CAR-GPC3 T-cell therapy in advanced hepatocellular carcinoma: a proof-of-concept treatment strategy. (PubMed, Cancer Commun (Lond)) - No abstract available

Journal • Metastases • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

CT0180-CG1203: Phase I Clinical Trial of CT0180 Cells in the Treatment of Hepatocellular Carcinoma (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: Zhejiang University | Trial completion date: Apr 2023 ➔ Jun 2024 | Trial primary completion date: Mar 2023 ➔ Jun 2024

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3 • PD-L1

Phase I trial of chimeric anti-GPC3 scFv-CD3ε engineered T cells (CT0180) in patients with advanced hepatocellular carcinoma. (ASCO 2023) - P1 | "Lymphodepletion regimen comprised fludarabine 25 mg/m2 and cyclophosphamide 300 mg/m2 daily for 3 days...Grade 1 cytokine release syndrome was observed in 6 patients; tocilizumab was given in one patient and no glucocorticoids were used... CT0180 demonstrated manageable safety profile and promising antitumor potential. Further exploration of CT0180 in HCC is needed. Clinical trial information: NCT04756648."

Clinical • Metastases • P1 data • Gastrointestinal Cancer • Hematological Disorders • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Neutropenia • Oncology • Solid Tumor • GPC3 • IL6

CT0180-CG1203: Phase I Clinical Trial of CT0180 Cells in the Treatment of Hepatocellular Carcinoma (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: Zhejiang University | Trial primary completion date: Apr 2022 ➔ Mar 2023

Metastases • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3 • PD-L1

A phase I study of anti-GPC3 chimeric antigen receptor modified T cells (GPC3 CAR-T) in Chinese patients with refractory or relapsed GPC3+ hepatocellular carcinoma (r/r GPC3+ HCC). (ASCO 2017) - P1; "Phase I trial shows GPC3 CAR-T is feasible and safe for Chinese pts with r/r GPC3+ HCC, and holds promising antitumor potential when LDC is applied along with GPC3 CAR-T."

Adverse events • Clinical • P1 data • Biosimilar • Gene Therapies • Hepatocellular Cancer • Immunology

Chimeric Antigen Receptor T Cells Targeting Glypican-3 (clinicaltrials.gov) - P1 | N=9 | Completed | Sponsor: CARsgen Therapeutics Co., Ltd. | Recruiting ➔ Completed | N=15 ➔ 9 | Trial completion date: May 2024 ➔ Dec 2021

CAR T-Cell Therapy • Enrollment change • Trial completion • Trial completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

[VIRTUAL] Phase I trial of fourth-generation chimeric antigen receptor T-cells targeting glypican-3 for advanced hepatocellular carcinoma. (ASCO 2021) - P1 | "Among them, 1 patient received half dose of sorafenib and 3 patients received half dose of regorafenib along with cell infusion...Patients recovered from CRS after tocilizumab therapy with corticosteroid (4 patients) or without... Our study is the first to report that 4G-CAR-GPC3 T cell therapy in combination with TKIs has a manageable safety profile while demonstrating potential antitumor activity for heavily pretreated advanced HCC patients; however, CRS should be diligently managed."

CAR T-Cell Therapy • P1 data • Gastrointestinal Cancer • Hematological Disorders • Hepatocellular Cancer • Inflammation • Oncology • Solid Tumor • Transplantation • GPC3

CISLD-4: 4th Generation Chimeric Antigen Receptor T Cells Targeting Glypican-3 (clinicaltrials.gov) - P1; N=6; Completed; Sponsor: Zhejiang University; Recruiting ➔ Completed; N=36 ➔ 6; Trial completion date: Jun 2022 ➔ Dec 2020; Trial primary completion date: Jun 2021 ➔ Dec 2020

CAR T-Cell Therapy • Clinical • Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

CT0180-CG1203: Phase I Clinical Trial of CT0180 Cells in the Treatment of Hepatocellular Carcinoma (clinicaltrials.gov) - P1; N=21; Recruiting; Sponsor: Zhejiang University; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3 • PD-1 • PD-L1

CT0180-CG1203: Phase I Clinical Trial of CT0180 Cells in the Treatment of Hepatocellular Carcinoma (clinicaltrials.gov) - P1; N=21; Not yet recruiting; Sponsor: Zhejiang University

Clinical • New P1 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor • GPC3 • PD-1 • PD-L1

Clinical Study of Redirected Autologous T Cells With a Chimeric Antigen Receptor in Patients With Malignant Tumors (clinicaltrials.gov) - P=N/A; N=18; Active, not recruiting; Sponsor: Kang YU; Recruiting ➔ Active, not recruiting; N=48 ➔ 18; Trial completion date: Dec 2021 ➔ Dec 2023; Trial primary completion date: Dec 2019 ➔ Dec 2020

Clinical • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Esophageal Cancer • Follicular Lymphoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Hepatology • Leukemia • Lymphoma • Mantle Cell Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Pancreatic Cancer • Solid Tumor • CD19

Chimeric Antigen Receptor T Cells Targeting Glypican-3 (clinicaltrials.gov) - P1; N=15; Recruiting; Sponsor: Carsgen Therapeutics, Ltd.; Trial primary completion date: Jun 2020 ➔ Aug 2021

Clinical • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor

Clinical Study of Redirected Autologous T Cells With a Chimeric Antigen Receptor in Patients With Malignant Tumors (clinicaltrials.gov) - P=N/A; N=48; Recruiting; Sponsor: Kang YU; Not yet recruiting ➔ Recruiting; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Jun 2019 ➔ Dec 2019

Clinical • Enrollment open • Trial completion date • Trial primary completion date

Chimeric Antigen Receptor T Cells Targeting Glypican-3 (clinicaltrials.gov) - P1; N=15; Recruiting; Sponsor: Carsgen Therapeutics, Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

4th Generation Chimeric Antigen Receptor T Cells Targeting Glypican-3 (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Zhejiang University; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

CAR-GPC3 T Cells in Patients With Refractory Hepatocellular Carcinoma (clinicaltrials.gov) - P=N/A; N=7; Completed; Sponsor: RenJi Hospital; Recruiting ➔ Completed; N=20 ➔ 7; Trial completion date: Jun 2020 ➔ Oct 2018; Trial primary completion date: Dec 2019 ➔ Oct 2018

Clinical • Enrollment change • Trial completion • Trial completion date • Trial primary completion date

4th Generation Chimeric Antigen Receptor T Cells Targeting Glypican-3 (clinicaltrials.gov) - P1; N=36; Not yet recruiting; Sponsor: Zhejiang University

Clinical • New P1 trial