# Satricabtagene autoleucel

Source: https://onco.cc/drugs/satricabtagene-autoleucel/  
OnCo record `satricabtagene-autoleucel` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Satricabtagene autoleucel (satri-cel) is the first CAR-T therapy approved for a solid tumour (gastric cancer), in China.

## Summary

Satricabtagene autoleucel (satri-cel) is an autologous CAR-T built from a humanised scFv against Claudin 18.2, a tight-junction protein normally confined to gastric mucosa and exposed on a large share of gastric and pancreatic adenocarcinomas; lymphodepletion uses a nab-paclitaxel-containing regimen. CARsgen developed it. In the randomised phase 2 CT041-ST-01 trial in China (Lancet 2025), satri-cel improved progression-free survival versus physician's choice in pretreated CLDN18.2-positive gastric or gastro-oesophageal junction cancer (median 3.25 versus 1.77 months; the abstract reports no overall survival figures), and NMPA approval followed in 2025-26 per company reports; the phase 2 dose was 2.5 x 10^8 CAR-positive T cells. Cytokine release syndrome and cytopenias occur, and gastric mucosal injury is an expected on-target effect. US trials are ongoing, and durability and use in pancreatic cancer remain open. For a newcomer: the first CAR-T approved anywhere for a solid tumour.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-24
- Code: satri-cel, CT041
- Modality: CAR-T (Claudin 18.2)
- Mechanism: Humanised CLDN18.2 scFv CAR-T; lymphodepletion with nab-paclitaxel-containing regimen.
- Approvals: China 2025: CLDN18.2+ advanced gastric/GEJ adenocarcinoma, previously treated
- Dosing: Single IV infusion after lymphodepletion; 2.5 × 10⁸ CAR+ T cells (phase 2 dose); lymphodepletion includes nab-paclitaxel, fludarabine, cyclophosphamide

## Sources

- CT041-ST-01 (Lancet 2025): https://doi.org/10.1016/S0140-6736(25)00860-8

## Connected records

- cancers: [Claudin 18.2-positive gastric cancer](https://onco.cc/cancers/gastric-cldn18-2-positive/), [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/), [Metastatic pancreatic ductal adenocarcinoma](https://onco.cc/cancers/metastatic-pdac/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/)
- technologies: [CAR-T cell therapy](https://onco.cc/technologies/car-t/)
- targets: [Claudin 18.2](https://onco.cc/targets/cldn18-2/)
- companies: [CARsgen Therapeutics](https://onco.cc/companies/carsgen/)
- trials: [CT041-ST-01](https://onco.cc/trials/nct04581473/)
- pairings: [CLDN18.2 antibody first line → CLDN18.2 ADC or CAR-T on progression](https://onco.cc/pairings/cldn18-antibody-then-adc/)
- ideas: [In vivo CAR-T against solid-tumour antigens](https://onco.cc/ideas/idea-in-vivo-car-solid/), [Peritoneal-directed therapy for gastric cancer](https://onco.cc/ideas/idea-peritoneal-directed-gastric/)
- roadmaps: [Cell therapy roadmap: CD19 CAR-T → solid tumours → in vivo CAR](https://onco.cc/roadmaps/cell-therapy-roadmap/)
- people: [Changsong Qi](https://onco.cc/people/qi-changsong/), [Lin Shen](https://onco.cc/people/shen-lin/), [Zonghai Li](https://onco.cc/people/li-zonghai/)
- key papers: [Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) versus treatment of physician's choice for previously treated advanced gastric or gastro-oesophageal junction cancer (CT041-ST-01): a randomised, open-label, phase 2 trial](https://onco.cc/key-papers/paper-ct041-st-01-lancet-2025/)
- institutions: [Peking University Cancer Hospital](https://onco.cc/institutions/pku-cancer-hospital/), [Renji Hospital, Shanghai Jiao Tong University](https://onco.cc/institutions/renji-hospital/)

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