GT201 / Grit Biotechnology - LARVOL DELTA

Evaluation of autologous tumor-infiltrating lymphocytes (GT201) plus toripalimab in recurrent or metastatic head and neck cancer (ESMO 2026) - No abstract available

Metastases • Tumor-infiltrating lymphocyte • Head and Neck Cancer • Oncology • Solid Tumor

Phase I/II Clinical Study of GT201 Injection as Monotherapy or in Combination With PD-1 Inhibitor for Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=78 | Recruiting | Sponsor: Grit Biotechnology | N=18 ➔ 78 | Trial completion date: Sep 2026 ➔ Dec 2027 | Trial primary completion date: Sep 2026 ➔ Dec 2027

Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Evaluation of autologous tumor-infiltrating lymphocytes (GT201) plus toripalimab in recurrent or metastatic head and neck cancer. (ASCO 2026) - P=N/A | "GT201 combined with toripalimab demonstrated a manageable safety profile and encouraging antitumor activity in heavily pretreated R/M HNC, supporting further clinical development of this combination. Clinical trial information: NCT06190275. Research Sponsor: Grit Biotechnology."

Metastases • Tumor-infiltrating lymphocyte • Head and Neck Cancer • Nasopharyngeal Carcinoma • Neutropenia • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • IL15

Clinical Study of GT201 in the Treatment of Advanced Gynecological Tumors (Advanced Cervical Cancer) (clinicaltrials.gov) - P=N/A | N=4 | Terminated | Sponsor: Grit Biotechnology | N=26 ➔ 4 | Trial completion date: Jun 2026 ➔ Dec 2025 | Recruiting ➔ Terminated | Trial primary completion date: Jun 2026 ➔ Dec 2025; The study was terminated from a business perspective.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor

Clinical Study of GT201 in the Treatment of Advanced Gynecological Tumors (clinicaltrials.gov) - P1 | N=1 | Terminated | Sponsor: Grit Biotechnology | N=26 ➔ 1 | Trial completion date: Oct 2026 ➔ Dec 2025 | Recruiting ➔ Terminated | Trial primary completion date: Oct 2026 ➔ Dec 2025; The study was terminated from a business perspective.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Gynecologic Cancers • Oncology

Autologous Tumor-Infiltrating Lymphocyte Injection(GT201) for Treatment of Patients With Advanced Lung Cancer (clinicaltrials.gov) - P=N/A | N=2 | Terminated | Sponsor: Grit Biotechnology | N=40 ➔ 2 | Trial completion date: Jul 2027 ➔ Dec 2025 | Recruiting ➔ Terminated | Trial primary completion date: Jul 2027 ➔ Dec 2025; The study was terminated from a business perspective.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for the Treatment of Metastatic/Recurrent Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=2 | Terminated | Sponsor: Grit Biotechnology | N=30 ➔ 2 | Trial completion date: May 2025 ➔ Dec 2025 | Recruiting ➔ Terminated | Trial primary completion date: May 2025 ➔ Dec 2025; The study was terminated from a business perspective.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Oncology • Solid Tumor

GT201 Injection in Combination With Teraplizumab Injection for Treatment of Patients With Non-small Cell Lung Cancer (clinicaltrials.gov) - P=N/A | N=2 | Terminated | Sponsor: Grit Biotechnology | N=20 ➔ 2 | Trial completion date: Jan 2027 ➔ Dec 2025 | Recruiting ➔ Terminated | Trial primary completion date: Jan 2027 ➔ Dec 2025; The study was terminated from a business perspective.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=6 | Terminated | Sponsor: Grit Biotechnology | N=42 ➔ 6 | Trial completion date: May 2025 ➔ Dec 2025 | Recruiting ➔ Terminated | Trial primary completion date: May 2025 ➔ Dec 2025; The study was terminated from a business perspective.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Oncology • Solid Tumor

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

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

Armored TIL GT201 induces potent tumor-specific TCR expansion and durable antitumor responses in advanced solid tumor (AACR 2026) - "GT201 exhibited a manageable safety profile and encouraging early efficacy in patients with advanced solid tumor, with ongoing enrollment to further inform clinical outcomes. Integrated multi-omics analyses indicate that expansion of tumor-specific TCRs, during both manufacturing and post-infusion in responding patients, correlates more strongly with clinical benefit than expansion of TIL-only TCRs. Continued longitudinal sampling and functional validation of putative tumor-specific clonotypes will be essential to establish their utility as biomarkers of response in GT201 therapy."

Metastases • Oncology • Solid Tumor • CD8 • IL15 • IL2

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