CT041 Satricabtagene Autoleucel Satri-Cel 舒瑞基奥仑赛 CLDN18.2 Claudin18.2 CAR-T Cell Therapy Solid Tumour Gastric Cancer Gastroesophageal Junction GEJ Adenocarcinoma NMPA Approval China June 2026 CARsgen 科济药业 First Approved Solid Tumor CAR-T HER2 Negative Second Line Failure CT041-ST-01 NCT04581473 Lancet ASCO 2025 PFS OS CRS ICANS International Patients MDT Second Opinion
This page belongs to ChinaMed Waypoint's CAR-T and Cell Therapy specialty hub. It explains satricabtagene autoleucel (CT041, satri-cel, 舒瑞基奥仑赛) — the first approved CAR-T therapy for a solid tumour in China — covering mechanism, NMPA approval criteria, confirmatory Phase II trial results, safety, pipeline studies in earlier treatment lines and pancreatic cancer, CAR-T access and coordination with Chinese oncology specialists, and what international gastric cancer patients should ask before treatment planning.
What Is CT041 (Satri-Cel)? The World's First Approved CAR-T for Solid Tumours
NMPA approval guide for international patients and physicians — approved indication, regulatory pathway, CT041-ST-01 trial data, pipeline, and access in China
How this article differs from our CT041 explainer: this page focuses on the 22 June 2026 NMPA approval — label criteria, regulatory timeline, pivotal trial results, and how to access satri-cel in China. For why solid-tumour CAR-T has been difficult, what long-term outcomes remain uncertain, and a step-by-step eligibility decision framework, see our companion guide on CAR T for solid tumours: what to expect.
On 22 June 2026, China's National Medical Products Administration (NMPA) approved satricabtagene autoleucel injection (舒瑞基奥仑赛注射液, development code CT041, also known as satri-cel) for patients with Claudin18.2 (CLDN18.2)-positive, HER2-negative advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have failed at least second-line systemic therapy. Every CAR-T therapy approved before this — in China and worldwide — targeted blood cancers only. Satri-cel is therefore the first CAR-T approved for any solid tumour globally, with China as the first market. This article explains what the approval means clinically — but CAR-T is a complex cellular therapy that only a qualified specialist team can evaluate. Whether satri-cel is appropriate for any individual patient can only be decided by physicians who know the full medical history, biomarker results, and treatment arc.
Before anything else: reading about a newly approved CAR-T does not mean a patient should request it, switch treatment, or travel for care independently. Cellular therapies require biomarker confirmation, T-cell collection, manufacturing, lymphodepletion, and specialised inpatient monitoring — all sequenced within a physician-led plan. All decisions about starting, deferring, or choosing an alternative must follow the advice of the treating oncology team or a specialist who has reviewed the complete case.
If your physician agrees that exploring satri-cel may be worth discussing, ChinaMed Waypoint's partner hospitals in China can administer this CAR-T. Contact us for a complimentary remote eligibility assessment — we can review your records with specialist centres to help clarify whether you may meet the criteria, before any travel or treatment commitment. An eligibility assessment is not a treatment recommendation; final decisions remain with your treating physicians.
Key points at a glance:
- •Satri-cel is the world's first CAR-T approved for any solid tumour — not merely a China-first; all prior CAR-T approvals worldwide were for blood cancers
- •Approved indication: CLDN18.2-positive, HER2-negative advanced gastric/GEJ adenocarcinoma after ≥2L systemic therapy failure — not first-line or for all gastric cancers
- •Pivotal data from CT041-ST-01 (NCT04581473, published in The Lancet, ASCO 2025) showed significantly improved PFS vs standard treatment in the studied population
- •CAR-T becomes the second drug class to succeed on the CLDN18.2 target in gastric cancer, after monoclonal antibody approaches such as zolbetuximab
- •Earlier-line gastric studies and pancreatic cancer trials remain in development — approved use today is limited to the gastric/GEJ later-line label
- •Individual eligibility requires CLDN18.2/HER2 testing, CAR-T fitness assessment, and specialist review — patients should not self-select this therapy
Why This Is a Global First — Not Just a China Milestone
Since 2017–2018, CAR-T has changed outcomes in relapsed or refractory blood cancers — lymphoma, leukaemia, and myeloma — but no solid-tumour CAR-T had received regulatory approval anywhere in the world until satri-cel. China was the first country to grant marketing approval, making this a globally historic regulatory event rather than a China-only development story.
The approved use today is narrow: later-line CLDN18.2-positive, HER2-negative advanced gastric/GEJ adenocarcinoma. That specificity matters — this is not approval for all solid tumours or all gastric cancers. For the scientific context on why solid-tumour CAR-T took so long and what remains uncertain even after approval, see our CAR T for solid tumours decision guide.
CAR-T & Cell Therapy hub context
This article belongs to ChinaMed Waypoint's CAR-T and cell therapy resources for international families evaluating cellular therapy access and coordination with Chinese oncology specialists. Satri-cel adds a new commercially approved option — but CAR-T evaluation, manufacturing logistics, and inpatient monitoring remain physician-led processes.
What Is Satri-Cel (CT041)?
Satri-cel is an autologous, humanised CAR-T developed by CARsgen Therapeutics (科济药业) that targets Claudin18.2 (CLDN18.2). A patient's T-cells are collected, engineered to recognise CLDN18.2-expressing cells, manufactured, and reinfused after lymphodepleting chemotherapy — the same general cellular therapy pathway as blood-cancer CAR-T products, but with gastric-cancer-specific eligibility and monitoring requirements.
For step-by-step process details (leukapheresis, manufacturing timelines, CRS/ICANS monitoring), see our CAR-T process and timeline guide. For why CLDN18.2 targeting matters, how CAR-T differs from antibody approaches such as zolbetuximab, and what realistic expectations should be, see our solid-tumour CAR-T explainer and gastric cancer treatment in China.
Who Is the NMPA Approval For?
The 22 June 2026 NMPA approval specifies the following patient population. This is a label summary — individual treatment decisions require physician and CAR-T centre assessment.
- Advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma
- CLDN18.2-positive (confirmed by appropriate biomarker testing, typically IHC on tumour tissue)
- HER2-negative
- Failure of at least second-line systemic therapy
- Additional CAR-T eligibility criteria: organ function, performance status, successful T-cell collection, and centre-specific requirements
Important: CLDN18.2 testing is not always included in standard pathology panels — it must be specifically requested and performed on adequate tumour tissue. HER2 status must also be documented. Matching biomarker criteria on paper is not the same as being the right patient for CAR-T. Only the treating physician — who understands prior responses, current disease burden, T-cell fitness, and the full treatment sequence — can determine whether satri-cel belongs in the plan.
Regulatory Pathway in China
Satri-cel moved through China's accelerated regulatory pathways before approval:
March 2025
Breakthrough therapy designation granted by CDE
May 2025
Included in priority review pathway
June 2025
New drug application (NDA) accepted by CDE
22 June 2026
NMPA marketing approval granted
CLDN18.2 is one of the most actively studied targets in gastric cancer, with dozens of clinical programmes registered globally. Satri-cel's approval makes CAR-T the second therapeutic class — after monoclonal antibodies — to achieve regulatory success on this target in China.
What Did the CT041-ST-01 Trial Show?
Approval was based on the confirmatory Phase II CT041-ST-01 study (NCT04581473), conducted in China in patients with advanced gastric/GEJ adenocarcinoma. Results were published in The Lancet and presented as an oral abstract at the 2025 ASCO Annual Meeting.
Intent-to-treat (ITT) population
Independent review committee (IRC) assessment
- Median PFS: 3.25 vs 1.77 months (HR 0.366)
- Progression/death risk reduced by approximately 63%
- Median OS: 7.92 vs 5.49 months (HR 0.693) — favourable trend
- Primary endpoint (PFS) met
Modified ITT (mITT) — treated patients
- Median PFS: 4.37 vs 1.84 months (HR 0.304)
- Progression/death risk reduced by approximately 70%
- Median OS: 8.61 vs 5.49 months (HR 0.601)
- Death risk reduced by approximately 40%
These results were reported in the trial population. Trial outcomes in a study group do not predict individual patient response, durability, or long-term survival. OS data maturity and extended follow-up should be considered in treatment planning discussions with a specialist.
For patients whose gastric cancer has progressed after multiple prior lines, this trial addresses a setting where options are often limited. A structured MDT second opinion can help determine whether satri-cel — or other later-line approaches including CLDN18.2 antibodies or clinical trials — is medically appropriate for a specific case.
What About Safety?
In CT041-ST-01, satri-cel was reported as generally well tolerated in the studied population. Overall tolerability was favourable relative to the CAR-T class profile in blood cancers at comparable stages of development.
- 4 cases of grade 3 cytokine release syndrome (CRS)
- No grade 4–5 CRS reported
- No immune effector cell-associated neurotoxicity syndrome (ICANS) reported
CRS and ICANS remain the most significant acute risks with any CAR-T therapy. Chinese centres with active CAR-T programmes have established monitoring and management protocols. For a general overview of CAR-T side effects, see our CAR-T side effects guide.
Supportive care — including symptom management, nutrition, and emotional support — typically runs alongside active cancer treatment. For international patients in China, integrative supportive approaches such as Traditional Chinese Medicine may be coordinated within hospital systems to help manage fatigue, appetite, or recovery, but only alongside standard oncology treatment and with medical team approval — not instead of CAR-T, chemotherapy, or other systemic therapy.
Pipeline: Earlier Lines and Pancreatic Cancer
Beyond the approved later-line gastric/GEJ indication, CARsgen is exploring satri-cel in earlier treatment settings and other CLDN18.2-positive solid tumours. These programmes remain investigational until separate regulatory approvals are granted.
Gastric/GEJ — treatment line expansion
- • Post-surgical adjuvant consolidation after adjuvant therapy (investigator-initiated trial, NCT06857786)
- • Sequential therapy after first-line treatment in advanced disease (investigator-initiated trial, NCT07179484)
Pancreatic cancer — CT041-ST-05 (NCT05911217)
At ESMO 2025, CARsgen presented data from a Phase Ib registration-enabling adjuvant study — described as the first proof-of-concept trial exploring CAR-T for solid tumour adjuvant treatment globally. The study enrolled patients with resected pancreatic ductal adenocarcinoma (PDAC) who were CLDN18.2-positive, had completed at least three months of adjuvant chemotherapy with abnormal CA19-9 levels, and showed no recurrence evidence.
- 6 patients received satri-cel infusion as of April 2025
- Median follow-up 6.05 months from cell infusion
- 1 recurrence; remaining patients disease-free at data cutoff
- Median DFS and OS not yet reached; 9-month DFS rate 83.3%
- 5 of 6 (83.3%) showed significant CA19-9 decline (51.3%–96.1%)
Early-phase data in a very small cohort; not an approved indication. Individual outcomes cannot be inferred from group results.
Approval-Specific Questions to Discuss With Your Doctor
- →Do I meet the approved label criteria — CLDN18.2-positive, HER2-negative, advanced gastric/GEJ adenocarcinoma, and ≥2L systemic therapy failure?
- →Are CLDN18.2 and HER2 results documented on adequate tumour tissue, or is re-testing needed?
- →Does my treating team agree satri-cel should be compared with CLDN18.2 antibody therapy or other later-line options?
- →If care in China is being considered, is satri-cel commercially accessible at an appropriate CAR-T centre under current regulations?
Broader questions — how to test for CLDN18.2, where CAR-T fits in treatment sequence, realistic response expectations, and a six-step decision framework — are covered in our CAR T for solid tumours: what to expect guide, not repeated here.
What Happens Next
A new CAR-T approval adds a possible tool to the oncologist's armamentarium — it does not replace clinical judgment or the complex logistics of cellular therapy. For patients and caregivers, the appropriate response is to bring informed questions to the treating doctor, not to decide independently that this CAR-T should be used.
For international families, the practical sequence usually begins with confirming biomarker status and full treatment history with the current oncology team, then — if the doctor agrees it may be worth exploring — requesting specialist review of whether satri-cel or other later-line options fit the individual case, including CAR-T centre capacity and manufacturing timelines. ChinaMed Waypoint's partner hospitals can administer satri-cel; families who wish to explore this pathway may contact us for a complimentary eligibility assessment before making any travel or treatment decisions.
Evaluating CAR-T for Advanced Gastric Cancer in China?
If you or a family member has CLDN18.2-positive gastric or GEJ cancer progressing after prior systemic therapy, our partner hospitals can administer satri-cel (CT041). Contact us for a complimentary remote eligibility assessment — we can review your records with specialist centres before any travel or treatment commitment is made.
Request a Free Eligibility AssessmentFrequently Asked Questions
What is CT041 (satri-cel / 舒瑞基奥仑赛)?
CT041 (satricabtagene autoleucel, satri-cel, 舒瑞基奥仑赛注射液) is an autologous, humanised CAR-T cell therapy developed by CARsgen Therapeutics (科济药业) that targets Claudin18.2 (CLDN18.2). It engineers a patient's own T-cells to recognise and attack CLDN18.2-expressing cancer cells. On 22 June 2026, China's NMPA approved it for CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma after failure of at least second-line systemic therapy — making it the first approved CAR-T therapy for a solid tumour globally.
Who is eligible for satri-cel under its approved indication in China?
The approved indication covers patients with CLDN18.2-positive, HER2-negative advanced gastric or GEJ adenocarcinoma who have failed at least second-line systemic treatment. CLDN18.2 status must be confirmed by appropriate biomarker testing (typically immunohistochemistry on tumour tissue). CAR-T also requires adequate organ function, acceptable performance status, and successful T-cell collection — eligibility is assessed individually by the treating team, not from the label alone.
What did the CT041-ST-01 trial show?
Approval was based on the confirmatory Phase II CT041-ST-01 study (NCT04581473), published in The Lancet and presented at ASCO 2025. In the intent-to-treat population, satri-cel significantly improved median progression-free survival versus standard treatment (3.25 vs 1.77 months; HR 0.366), with a 63% reduction in progression/death risk. Overall survival showed a favourable trend (median 7.92 vs 5.49 months; HR 0.693). In the modified ITT population who received treatment, median PFS was 4.37 vs 1.84 months (HR 0.304) and median OS 8.61 vs 5.49 months (HR 0.601). Results apply to the studied population; individual outcomes may differ.
Is CT041 approved for pancreatic cancer?
Not as a commercial approved indication at the time of the gastric/GEJ approval. CARsgen is studying satri-cel in pancreatic ductal adenocarcinoma (PDAC) in clinical trials, including an adjuvant Phase Ib study (CT041-ST-05, NCT05911217) with early data presented at ESMO 2025. Pancreatic cancer use remains investigational until separate regulatory approval is granted. Patients should not assume pancreatic eligibility based on the gastric cancer approval.
Is satri-cel approved outside China?
As of its 22 June 2026 NMPA approval, satri-cel (CT041) was the first CAR-T therapy approved for any solid tumour globally — and that first approval was in China. Approval status in the United States, Europe, and other markets may differ and should be verified for each country. International patients should not assume global commercial availability based on the China approval alone.
Should patients ask their doctor for CT041 after reading about the approval?
Patients may discuss the approval with their treating oncologist, but should not request or pursue satri-cel independently. A newly approved CAR-T is a complex cellular therapy that only a qualified specialist team can evaluate — considering CLDN18.2 and HER2 status, prior treatment lines, disease burden, organ function, T-cell fitness, and whether CAR-T fits appropriately in the treatment sequence. All decisions to use, defer, or choose an alternative must follow physician advice. ChinaMed Waypoint's partner hospitals in China can administer satri-cel; families may contact ChinaMed Waypoint for a complimentary remote eligibility assessment before any travel or treatment commitment.
Disclaimer: ChinaMed Waypoint is a coordination service, not a medical provider. Nothing in this article constitutes medical advice, a treatment recommendation, or a suggestion that any patient should receive satri-cel (CT041). New drug approvals describe what is medically possible under specific conditions — only a qualified oncologist and CAR-T specialist team who know the individual case can decide whether a therapy should be used. All treatment decisions must follow physician advice.
Related Guides
CAR T for Solid Tumours: What to Expect
Why solid-tumour CAR-T was difficult, what remains uncertain, and a step-by-step eligibility decision framework — without repeating approval label details.
CAR-T Process and Timeline in China
Step-by-step guide from eligibility review through leukapheresis, manufacturing, infusion, and follow-up.
Gastric Cancer Treatment in China
HER2, CLDN18.2, immunotherapy, and the broader gastric cancer treatment landscape in China.
Request a Structured CAR-T Evaluation
If advanced gastric or GEJ cancer is progressing after prior therapy and CLDN18.2-positive status is confirmed, our partner hospitals can administer satri-cel. Contact us for a complimentary eligibility assessment, or request a structured MDT review if your physician agrees further specialist input is needed.