GK01 / Beijing Geek Gene - LARVOL DELTA

A Clinical Study GK01 Cell Injection in Subjects With Advanced Lung Cancer (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Beijing Geekgene Technology Co., LTD

New P1 trial • Lung Cancer • Oncology • Solid Tumor

GK01 stemness-enriched tumor-reactive T-cell therapy plus IL-2 in advanced solid tumors: ORR and clonal persistence results in a first-in-human phase I study (GUARDIAN-01). (ASCO 2026) - P1 | "In this first-in-human study, GK01 plus IL-2 demonstrated a favorable safety profile with no DLTs and manageable toxicity. The TSCM-enriched product achieved a 67% ORR and 100% DCR, with product-derived clonotypes persisting at > 90% of the T-cell repertoire at 2 months. These findings validate the stemness-enriched T-cell platform and support expansion cohorts in selected solid tumor indications."

First-in-human • Metastases • P1 data • Dermatopathology • Hematological Disorders • Leukopenia • Melanoma • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • IFNG • IL2

A Clinical Study GK01 Injection in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: Beijing Geekgene Technology Co., LTD

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors. (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Beijing Geekgene Technology Co., LTD

New P1 trial • Solid Tumor

GK01IIT-TZ03: A Clinical Study to Evaluate GK01 Cell Injection in Combination With PD-1 Monoclonal Antibody for Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P1 trial • Colorectal Cancer • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

A Single-Arm, Open-Label Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors. (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Beijing Geekgene Technology Co., LTD

New P1 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Lung Cancer • Oncology • Solid Tumor

GUARDIAN-02: A Single-arm, Open-label Study of GK01 in Combination With or Without Chemotherapy for the Adjuvant Treatment of Solid Tumors (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P1 trial • Cholangiocarcinoma • Gastric Cancer • Solid Tumor

Tumor-reactive T cell therapy (GK01) shows promising antitumor activity in penile squamous cell carcinoma (PSCC): A case report from the GUARDIAN study [WITHDRAWN] (ESMO 2025) - No abstract available

Case report • Clinical • Oncology • Penile Cancer • Squamous Cell Carcinoma