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Satricabtagene autoleucel (satri-cel) is the first CAR-T therapy approved for a solid tumour (gastric cancer), in China.
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.
Humanised CLDN18.2 scFv CAR-T; lymphodepletion with nab-paclitaxel-containing regimen. Connects to Claudin 18.2.
1.Patient's T cells are collected by leukapheresis
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Source: www.carsgen.com. Doses are for orientation; the current label governs.
Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request.
Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request.
Sources: CMS Medicare Coverage Database (NCDs and LCDs). Not medical or financial advice; verify with your plan.
Sources: NICE search: satricabtagene autoleucel. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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RMAT designation, CLDN18.2+ gastric cancer source
First CAR-T approved for a solid tumour (CLDN18.2+ gastric/GEJ adenocarcinoma) source
| Region | Year | Indication |
|---|---|---|
| China | 2025 | CLDN18.2+ advanced gastric/GEJ adenocarcinoma, previously treated |
| Adverse event |
|---|
| Cytokine release syndrome |
| Gastric mucosal injury / nausea |
| Cytopenias |
| Infections |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| China | NMPA approved 2025-26; self-pay | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Query for this drug: (TITLE:"Satricabtagene autoleucel" OR ABSTRACT:"Satricabtagene autoleucel" OR TITLE:"satri-cel" OR ABSTRACT:"satri-cel" OR TITLE:"CT041" OR ABSTRACT:"CT041") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Satricabtagene autoleucel, not a curated reading list.
Shares CARsgen Therapeutics, Claudin 18.2-positive gastric cancer, Metastatic pancreatic ductal adenocarcinoma, Gastric & gastro-oesophageal junction cancer.
Shares CLDN18.2 antibody first line → CLDN18.2 ADC or CAR-T on progression, Claudin 18.2-positive gastric cancer, Claudin 18.2, Metastatic pancreatic ductal adenocarcinoma.
Shares Renji Hospital, Shanghai Jiao Tong University, Zonghai Li, CARsgen Therapeutics, CAR-T cell therapy.
Shares Zonghai Li, In vivo CAR-T against solid-tumour antigens, Cell therapy roadmap: CD19 CAR-T → solid tumours → in vivo CAR, CAR-T cell therapy.
Shares Claudin 18.2-positive gastric cancer, Metastatic pancreatic ductal adenocarcinoma, Gastric & gastro-oesophageal junction cancer, Pancreatic ductal adenocarcinoma.
Shares CLDN18.2 antibody first line → CLDN18.2 ADC or CAR-T on progression, Claudin 18.2, Gastric & gastro-oesophageal junction cancer.
Shares Claudin 18.2-positive gastric cancer, Claudin 18.2, Gastric & gastro-oesophageal junction cancer, Pancreatic ductal adenocarcinoma.
Shares CLDN18.2 antibody first line → CLDN18.2 ADC or CAR-T on progression, Claudin 18.2-positive gastric cancer, Claudin 18.2, Gastric & gastro-oesophageal junction cancer.