Satricabtagene autoleucel
Satricabtagene autoleucel (satri-cel) is the first CAR-T therapy approved for a solid tumour (gastric cancer), in China.
CARsgen's CLDN18.2 CAR-T. Randomised phase 2 in China (2025) showed PFS and OS benefit versus physician's choice in pretreated CLDN18.2+ gastric/GEJ cancer; NMPA approval followed in 2025-26 per company reports. US trials ongoing. Gastric mucosal toxicity is on-target.
1.Patient's T cells are collected by leukapheresis
- Route
- Single IV infusion after lymphodepletion
- Schedule
- 2.5 × 10⁸ CAR+ T cells (phase 2 dose); lymphodepletion includes nab-paclitaxel, fludarabine, cyclophosphamide
- Monitoring
- CRS, gastric mucosal injury (on-target), cytopenias
Source: www.carsgen.com. Doses are for orientation; the current label governs.
- Medicare
- Not covered (not FDA-approved)
Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request.
- Commercial insurance
- unknown
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.
- Notes
- No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
- NHS England
- Not routinely funded
Sources: NICE search: satricabtagene autoleucel. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- Jan 2022DesignationUS
RMAT designation, CLDN18.2+ gastric cancer source
- Sept 2025ApprovalChina
First CAR-T approved for a solid tumour (CLDN18.2+ gastric/GEJ adenocarcinoma) source
Approvals
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery 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.