GT 316 / Grit Biotechnology - LARVOL DELTA

Autologous Tumor Infiltrating Lymphocyte Injection for the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=2 | Terminated | Sponsor: Grit Biotechnology | N=36 ➔ 2 | Recruiting ➔ Terminated; The study was terminated from a business perspective.

Enrollment change • Trial termination • Oncology • Solid Tumor

Clinical Study of Autologous Tumor Infiltrating Lymphocyte Injection (GT316) in the Treatment of Advanced Solid Tumors (Gynecological Tumors) (clinicaltrials.gov) - P=N/A | N=0 | Withdrawn | Sponsor: Grit Biotechnology | N=36 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Gynecologic Cancers • Oncology • Solid Tumor

GT316: a next-generation TIL therapy identified through genome-wide CRISPR screening with promising efficacy in advanced solid tumors (AACR 2025) - "Data collection on additional responses is ongoing. In summary, these findings highlight the utility of the ImmuTFinder platform for discovering novel immunoregulatory targets and demonstrate the potential of GT316 as a next-generation TIL therapy for advanced solid tumors."

Clinical • First-in-human • Metastases • Cervical Cancer • Melanoma • Oncology • Ovarian Cancer • Solid Tumor • IL2

A first-in-human study of CRISPR/Cas9-engineered tumor infiltrating lymphocytes (TILs) product GT316 as monotherapy in advanced solid tumors. (ASCO 2024) - P=N/A | "The first-in-human study of GT316, a CRISPR/Cas9-dual KO anti-exhaustion TIL product, demonstrates good tolerability with encouraging preliminary anti-tumor efficacy as a monotherapy in pts with advanced solid cancers. The infusion of GT316 was associated with robust TIL expansion and IFN-γ secretion. Updated data with additional follow-up will be continuously collected, and OBD will be determined based on the overall data of safety and preliminary efficiency."

Metastases • Monotherapy • P1 data • Tumor-infiltrating lymphocyte • Cervical Cancer • Colorectal Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • IFNG • IL2

The Discovery and Development of GT316 as a CRISPR/Cas9-Dual KO Anti-Exhaustion TIL Product for Advanced Solid Tumors (ASGCT 2024) - "One PR and one CR have been observed as early as 4 weeks post GT316 infusion. In summary, these data demonstrated that our ImmuT Finder® platform enables unbiased discovery of potent and novel targets for the development of T cell therapy and support further clinical assessment of GT316 as a next-generation TIL therapy."

Metastases • Oncology • Solid Tumor • IL2

Clinical Study of Autologous Tumor Infiltrating Lymphocyte Injection (GT316) in the Treatment of Advanced Solid Tumors (Gynecological Tumors) (clinicaltrials.gov) - P=N/A | N=36 | Recruiting | Sponsor: Grit Biotechnology

New trial • Gynecologic Cancers • Oncology • Solid Tumor

Autologous Tumor Infiltrating Lymphocyte Injection for the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Grit Biotechnology

Metastases • New P1 trial • Oncology • Solid Tumor

The discovery and development of a CRISPR/Cas9-engineered tumor-infiltrating lymphocytes product (GT316) as a next-generation TIL therapy (AACR 2023) - "In summary, these data demonstrated that our ImmuT Finder® platform enables unbiased discovery of potent and novel targets for the development of T cell therapy and support the clinical assessment of GT316 as a next-generation TIL therapy. Currently, an investigator-initiated trial of GT316 is ongoing in China."

Tumor-infiltrating lymphocyte • Oncology • Solid Tumor • IL2