CELLULAR THERAPY

Selected solid-tumor CAR-T access.

Current clinical focus: CLDN18.2-positive advanced gastric / gastroesophageal junction cancer in appropriate later-line settings.

Pathology and biomarker relevance

CLDN18.2 status and HER2-negative context are central to determining relevance for this pathway.

Prior therapies and disease status

Prior systemic therapy, current imaging and disease status inform whether this later-line pathway may be appropriate.

Regulatory context

Regulatory approval does not by itself establish individual patient eligibility, center availability or a Vialen treatment pathway.

In China, satricabtagene autoleucel (satri-cel) was approved in June 2026 for patients with CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma after failure of at least two prior lines of therapy. It is the first CAR-T therapy approved for the treatment of a solid tumor. Other solid-tumor CAR-T approaches remain investigational or program-specific.

Center-specific review

Clinical suitability for this pathway is determined by the treating center against its current program criteria.