By Fineline Cube 
CARsgen Therapeutics Holdings Limited (HKG: 2171) today disclosed interim data from the Phase Ib registrational study CT041‑ST‑05 (NCT05911217) of Satricabtagene Autoleucel Injection (CT041) presented at the European Society for Medical Oncology (ESMO) Congress 2025. The trial evaluated the adjuvant efficacy of this autologous CAR‑T cell therapy in Claudin‑18.2‑positive pancreatic ductal adenocarcinoma (PDAC) patients who had undergone curative resection, completed adjuvant chemotherapy, and remained disease‑free at baseline.
Trial Design & Patient Population
- Enrollment – 6 PDAC subjects (Claudin‑18.2 + , abnormal CA19‑9, ≥ 3 months adjuvant chemo, no recurrence).
- Study Period – 15 Sep 2023 to 11 Apr 2025 (data cutoff).
- Intervention – Single infusion of Satricabtagene Autoleucel Injection, followed by ≥ 4 weeks of follow‑up.
Key Clinical Outcomes
| Endpoint | Result |
|---|---|
| Disease‑Free Survival (DFS) | Median not reached; 9‑month DFS rate 83.3 % |
| Overall Survival (OS) | Median not reached |
| Disease Recurrence | 1/6 patients (16.7 %) recurred; 5/6 remained disease‑free |
| CA19‑9 Decline | 5/6 patients (83.3 %) showed ≥ 51.3 % reduction (range 51.3‑96.1 %) |
| Long‑Term Follow‑Up | 1 patient completed 52 weeks post‑infusion with no recurrence |
- Safety – No treatment‑related serious adverse events reported in the 6‑patient cohort.
Development Milestones
- June 25 2025 – China’s National Medical Products Administration (NMPA) accepted the New Drug Application (NDA) for Satricabtagene Autoleucel Injection in Claudin‑18.2‑positive advanced gastric/gastroesophageal junction adenocarcinoma (GC/GEJC) patients refractory to ≥ 2 prior lines of therapy.
- Strategic Positioning – Satricabtagene Autoleucel is the first‑in‑class autologous CAR‑T targeting Claudin‑18.2, with potential applicability across Claudin‑18.2‑positive solid tumors.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech