GT201 / Grit Biotechnology - LARVOL DELTA

Assessing the safety and efficacy of GT201: A first-in-class autologous tumor-infiltrating lymphocyte monotherapy in advanced solid tumors. (ASCO 2025) - P=N/A, P1/2 | "In patients with heavily pretreated advanced or metastatic solid tumors, GT201, infused after FC lymphodepleting chemotherapy and high-dose IL-2, exhibited a manageable safety profile. GT201 demonstrated a favorable clinical profile in HNSCC, with an encouraging objective response rate and durable responses. No Grade ≥3 adverse events related to GT201 treatment were observed, supporting its potential as a treatment option worth further exploration."

Clinical • Metastases • Monotherapy • Tumor-infiltrating lymphocyte • Cervical Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • IL15

Grit Biotechnology Presents Clinical Breakthroughs at 2025 ASCO Annual Meeting (PRNewswire) - "Grit Biotechnology Co., Ltd...announced today that three abstracts featuring new clinical data from tumor-infiltrating lymphocytes (TIL) therapies will be presented at the American Society of Clinical Oncology (ASCO) 42nd annual meeting, which is taking place in Chicago, IL from May 30th to June 3rd....Grit Bio will provide the clinical updates of its leading TIL programs, including GT101 - an unmodified TIL therapy in treating recurrent and metastatic cervical cancer, GT201 - an armored TIL product expressing membrane bond IL-15 complex in treating various solid tumors, and GT300 - a CRISPR/Cas-edited dual KO TIL product in treating advanced solid tumors."

Clinical data • Cervical Cancer • Solid Tumor

Clinical Study of GT201 in the Treatment of Advanced Gynecological Tumors (clinicaltrials.gov) - P1 | N=26 | Recruiting | Sponsor: Grit Biotechnology

New P1 trial • Gynecologic Cancers • Oncology

Autologous Tumor-Infiltrating Lymphocyte Injection(GT201) for Treatment of Patients with Advanced Lung Cancer (clinicaltrials.gov) - P=N/A | N=40 | Recruiting | Sponsor: Grit Biotechnology | N=16 ➔ 40

Enrollment change • Lung Cancer • Oncology • Solid Tumor

Clinical Study of GT201 in Combination with PD-1 Inhibitor for Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P=N/A | N=12 | Recruiting | Sponsor: Grit Biotechnology | N=32 ➔ 12

Enrollment change • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=42 | Recruiting | Sponsor: Grit Biotechnology | Phase classification: P1 ➔ P1/2 | N=26 ➔ 42

Enrollment change • Phase classification • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor

Grit Biotechnology Receives U.S. FDA Clearance of Investigational New Drug Application for GT201, a genetically engineered TIL, following its Chinese IND Approval (PRNewswire) - "Grit Biotechnology...has achieved a major milestone with its genetically engineered TIL product, GT201. Following its investigational new drug (IND) approval in China in July 2023, GT201 has now also received IND clearance from the U.S. FDA, paving the way for clinical trials in the United States....GT201 IND is approved by both U.S. FDA and China Center for Drug Evaluation (CDE) to enter clinical trials in both countries for advanced solid tumor patients....In addition, Grit's non-gene-engineered TIL program, GT101, is currently in Phase 2 (pivotal) trials and is on track to file for Biologics License Application (BLA) in 2025, making it the leading TIL pipeline in China."

China filing • IND • Solid Tumor

Autologous Tumor-Infiltrating Lymphocyte Injection(GT201) for Treatment of Patients With Advanced Lung Cancer (clinicaltrials.gov) - P=N/A | N=16 | Recruiting | Sponsor: Grit Biotechnology

Metastases • New trial • Lung Cancer • Oncology • Solid Tumor

Clinical Study of GT201 in Combination With PD-1 Inhibitor for Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P=N/A | N=32 | Recruiting | Sponsor: Grit Biotechnology | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Exploring the safety and efficacy of GT201 as a first-in-class autologous tumor-infiltrating lymphocyte monotherapy in advanced solid tumors. (ASCO 2024) - P1 | "In patients with heavily pretreated advanced or metastatic solid tumor, GT201, when infused after FC lymphodepletion and followed by high dose IL-2, exhibits a manageable safety profile. Notably, GT201 has demonstrated a favorable clinical profile in NSCLC, with an encouraging objective response rate, response durability, and no GT201-treatment related grade≥3 AEs."

Clinical • Metastases • Monotherapy • Tumor-infiltrating lymphocyte • Cervical Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • IL15

Clinical Study of GT201 in Combination With PD-1 Inhibitor for Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P=N/A | N=32 | Not yet recruiting | Sponsor: Grit Biotechnology | Trial completion date: Jan 2027 ➔ Apr 2027 | Initiation date: Jan 2024 ➔ Apr 2024 | Trial primary completion date: Jan 2027 ➔ Apr 2027

Combination therapy • Metastases • Trial completion date • Trial initiation date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

GT201 Injection in Combination With Teraplizumab Injection for Treatment of Patients With Non-small Cell Lung Cancer (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: Grit Biotechnology | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Clinical Study of GT201 in Combination With PD-1 Inhibitor for Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P=N/A | N=32 | Not yet recruiting | Sponsor: Grit Biotechnology | N=20 ➔ 32

Combination therapy • Enrollment change • Metastases • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Clinical Study of GT201 in Combination With PD-1 Inhibitor for Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P=N/A | N=20 | Not yet recruiting | Sponsor: Grit Biotechnology

Combination therapy • Metastases • New trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Clinical Study of GT201 in the Treatment of Advanced Gynecological Tumors (Advanced Cervical Cancer) (clinicaltrials.gov) - P=N/A | N=26 | Recruiting | Sponsor: Grit Biotechnology

Metastases • New trial • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor

GT201 Injection For The Treatment Of Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=18 | Recruiting | Sponsor: Grit Biotechnology

New P1/2 trial • Oncology • Solid Tumor

Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=26 | Recruiting | Sponsor: Grit Biotechnology | Phase classification: P1/2 ➔ P1

Metastases • Phase classification • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor

Harnessing the power of tumor-infiltrating lymphocytes: A first-in-human study of GT201 as monotherapy in advanced solid tumors. (ASCO 2023) - P1 | "The results of the first-in-human study of GT201, a mIL-15 expressed on TILs, demonstrate promising preliminary findings as a monotherapy in pts with advanced cancers. The administration of GT201 was associated with robust T cell expansion, as well as prolonged persistence of infused TILs. Results of mbIL-15 expressed TIL demonstrates that GT201 has good tolerability with encouraging preliminary antitumor activity as a monotherapy."

Metastases • Monotherapy • P1 data • Tumor-infiltrating lymphocyte • Cervical Cancer • Hematological Disorders • Leukopenia • Melanoma • Neutropenia • Oncology • Solid Tumor • IL15

A Functionally Enhanced Tumor-Infiltrating Lymphocytes Product (GT201) Exhibits Improved Persistence and Anti-Tumor Efficacy with Low IL-2 Dependency (ASGCT 2023) - "Taken together, GT201 demonstrated enhanced persistence and anti-tumor efficacy with low IL-2 dependency in vitro and in vivo. Currently, manufacturing process of GT201 TIL product has been successfully developed (StaViral®), and clinical assessment of GT201 as a next-generation TIL therapy is ongoing in an investigator-initiated trial in China."

Clinical • Tumor-infiltrating lymphocyte • Oncology • Solid Tumor • IFNG • IL2

Exploratory Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Gynecologic Tumors (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: RenJi Hospital

New P1 trial • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Single-arm Phase I/II Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=26 | Recruiting | Sponsor: Grit Biotechnology

Metastases • New P1/2 trial • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor

Single-center, Single-arm Phase I Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for the Treatment of Metastatic/Recurrent Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Grit Biotechnology

New P1 trial • Oncology • Solid Tumor