Cell therapies are emerging as a promising avenue for treating gastric cancer, with several companies and academic institutions advancing CAR-T and other innovative approaches. Recent developments highlight progress in clinical trials and novel therapeutic combinations. Gastric cancer remains a significant global health challenge, with approximately 26,890 people in the United States diagnosed each year, and an estimated 10,880 deaths expected in 2024 alone.
CARsgen Completes Enrollment for Satri-Cel Pivotal Trial
CARsgen Therapeutics announced the completion of patient enrollment in its pivotal Phase 2 clinical trial (NCT04581473) for satricabtagene autoleucel (satri-cel; CT041). Satri-cel is an investigational CAR-T therapy targeting CLDN18.2 for the treatment of CLDN18.2-positive advanced gastric/gastroesophageal (GC/GEJ) cancer. The open-label, multicenter, randomized trial in China compares satri-cel to a control group receiving paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab, based on physician's choice. The trial enrolled patients with advanced GC/GEJ who had failed two or more prior lines of therapy.
"We are very pleased to announce the successful completion of patient enrollment in the pivotal phase 2 clinical trial of satri-cel in China," said Zonghai Li, MD, PhD, founder, chairman of the board, CEO, and chief scientific officer of CARsgen Therapeutics. The company anticipates submitting a New Drug Application (NDA) and securing approval in China to benefit gastric cancer patients.
Novel iNKT Cell Therapy Combination Enters Phase 2
The first patient with refractory gastroesophageal cancer has been dosed in a Phase 2 trial evaluating a novel combination therapy. This combination includes agenT-797, an allogeneic invariant natural killer T (iNKT) cell therapy, along with Agenus’ botensilimab and balstilimab (BOT/BAL). The investigator-sponsored trial is being led by Yelena Janjigian, MD, Chief Gastrointestinal Oncology Service, Memorial Sloan Kettering Cancer Center.
"This study is an important step in new treatment combinations to improve outcomes for patients with refractory gastric cancers, an incurable disease with limited response to available therapies," said Dr. Janjigian. AgenT-797 has demonstrated the ability to target cancerous cells and is compatible with immune checkpoint inhibitors. The study aims to improve outcomes for patients with challenging GI cancers by leveraging the immune-enhancing potential of agenT-797.
Triumvira Immunologics Advances TAC T-cell Therapy
Triumvira Immunologics' TAC01-CLDN18.2, an investigational autologous T-cell antigen coupler (TAC) CLDN18.2-targeted T-cell product, is being evaluated in the first-in-human Phase 1/2 TACTIC-3 (NCT05862324) clinical trial for patients with various solid tumors. The trial is recruiting patients with gastric cancer, GEJ, esophageal adenocarcinoma (AC), non–small cell lung cancer (NSCLC), cholangiocarcinoma, pancreatic ductal AC (PDAC), ovarian mucinous cancer, and colorectal cancer.
TAC01-CLDN18.2 incorporates Triumvira’s proprietary TAC, designed to activate and direct T-cells against tumor cells. The Phase 1 dose escalation portion of the study will follow a standard 3+3 design, evaluating four dose levels in patients with HER2-negative cancers who have had at least two prior lines of therapy.
TCR-T Therapy for Lung and Gastric Cancer
Biosyngen received FDA clearance for its Phase 1/2 clinical trial of BRL03, a T-cell receptor T-cell (TCR-T) therapy, for patients with lung cancer, gastric cancer, and other advanced solid tumors. BRL03 is the company’s first TCR-T therapy to enter clinical trials, with preliminary safety and efficacy data already demonstrated in exploratory clinical trials. Lung cancer remains the leading cause of cancer deaths worldwide, while gastric cancer is the third most deadly malignant tumor.
