CLAUDIN 18.2 CAR T-CELL THERAPY FOR
ADVANCED GASTRIC CANCER

Claudin 18.2 directed CAR T-cell therapy reprograms a patient's own T cells to recognise and kill gastric cancer cells expressing the CLDN18.2 protein. Satri-cel (CT041) is the most clinically advanced candidate and is under NMPA review.

“Satri-cel is on track to become the first CAR T-cell therapy ever approved for a solid tumor, anywhere in the world.”

• The Therapy

  Autologous CAR T-cell product engineered with a humanised CLDN18.2 single-chain variable fragment, CD8α hinge, CD28 co-stimulatory domain, and CD3ζ signaling domain. Developed by CARsgen Therapeutics (2171.HK).

• Regulatory Lead

  NMPA accepted the NDA on 25 June 2025 with Priority Review and Breakthrough Therapy Designation. CARsgen expects approval in H1 2026. Not yet commercially available outside clinical trials.

After two prior lines of therapy, conventional third-line gastric cancer options deliver response rates around 4% and PFS measured in weeks. CLDN18.2-directed therapies open a new path for this unmet need.

“China's leadership in this space is concrete. The pivotal CT041-ST-01 trial of satri-cel was conducted across 24 sites in China under the leadership of Professor Lin Shen at Beijing Cancer Hospital (Peking University Cancer Hospital). The study is the first randomized controlled trial of any CAR T-cell therapy in any solid tumor, anywhere in the world. The trial enrolled 156 patients and the results were published in The Lancet on 7 June 2025. ”

• A Targetable Tumor Antigen

  CLDN18.2 is a tight junction protein normally sealed inside the stomach lining. Malignant transformation exposes it on cancer cell surfaces, making it visible to engineered immune cells while sparing most healthy tissue.

• Prevalence in G/GEJ Cancer

  Expressed at clinically meaningful levels in approximately 30-40% of gastric and GEJ adenocarcinomas. Also seen in pancreatic, biliary tract, and ovarian mucinous tumours. Testing is mandatory before therapy.

• A High-Burden Disease

  Gastric cancer falls disproportionately on Asia, with China carrying a major share of global cases. Advanced disease has limited third-line options, and PFS benefit measured in months is clinically meaningful.

• Multiple Drug Classes Targeting It

  Zolbetuximab (mAb, first-line), antibody drug conjugates (IBI343, CMG901 in trials), bispecific antibodies, and now satri-cel CAR T are all targeting CLDN18.2 in different lines of treatment.

A complete biomarker map is essential. HER2, MSI, PD-L1, and CLDN18.2 testing should be considered routine in advanced G/GEJ adenocarcinoma.

From biomarker confirmation to monitored recovery, the satri-cel pathway follows eight defined steps. Most patients spend 6-10 weeks in hospital and accommodation for the first treatment cycle.

1. 1

   CLDN18.2 IHC Confirmation

   Tumour tissue tested for Claudin 18.2 by validated immunohistochemistry. Positivity requires ≥2+ intensity in ≥40% of tumour cells.

2. 2

   Clinical Eligibility Review

   Team confirms diagnosis, prior treatment lines, organ function, performance status, and overall fitness.

3. 3

   Leukapheresis

   T cells collected from the patient's blood through a specialised cell separator, similar to plasma donation.

4. 4

   CAR T Manufacturing

   Cells sent to specialised facility, genetically engineered to express the CLDN18.2 CAR, then expanded to therapeutic doses.

5. 5

   Bridging Therapy (if needed)

   Short course of chemotherapy or other agents to stabilise disease during the manufacturing window.

6. 6

   Lymphodepleting Chemotherapy

   Brief regimen given before infusion to lower immune cell counts and make room for CAR T cell expansion.

7. 7

   CAR T Infusion

   Engineered cells infused intravenously. CT041-ST-01 allowed up to three infusions of 250 million cells each.

8. 8

   In-Hospital Monitoring & Recovery

   Close observation for at least 1-2 weeks per infusion. Monitoring for CRS, cytopenias, infection, and gastrointestinal effects.

Core product attributes for the most clinically advanced CLDN18.2 CAR T candidate.

As of May 2026, satri-cel is under active NMPA review. The NDA is accepted, Priority Review is in effect, and approval is expected in H1 2026. Commercial availability depends on final approval.

The first randomised controlled trial of CAR T-cell therapy in any solid tumor. 156 patients across 24 Chinese sites, 2:1 randomisation, IRC-assessed PFS as primary endpoint. Published in The Lancet, June 2025.

The headline figures clinicians and patients are using to assess satri-cel.

• 0.37PFS Hazard RatioA 63% relative reduction in risk of progression.
• 22%Confirmed ORRFive-fold higher than the 4% physician's choice arm.
• 24Trial Sites in ChinaMulticentre Phase 2 across leading cancer centres.
• 156Patients Randomised104 to satri-cel, 52 to physician's choice.

Honest hope, not false hope. Selected patients gain meaningful disease control and time; satri-cel does not promise a cure.

Eligibility is a clinical judgement based on disease, biomarker, prior lines, organ function, and fitness. Formal multidisciplinary review is essential.

Manageable when delivered at experienced cell therapy centres. CT041-ST-01 reported mostly low-grade CRS, expected cytopenias, and on-target gastric mucosal effects.

Hospitals with major roles in gastric cancer treatment, CLDN18.2 directed research, and cellular immunotherapy. Post-approval rollout will depend on hospital readiness and patient eligibility.

From first contact to follow-up coordination at home. Typical first cycle plans for 6-10 weeks in China.

1. 1

   Initial Contact & Records

   Share pathology, scans, blood work, and treatment history securely with CancerFax.

2. 2

   Pathology & Biomarker Review

   Hospital reviews case; CLDN18.2, HER2, PD-L1, MSI status confirmed or arranged.

3. 3

   Specialist Video Consultation

   Chinese oncologist gives an honest suitability opinion with interpretation if needed.

4. 4

   Hospital Selection & Admission

   Right centre chosen on clinical fit, geography, language, and family preference.

5. 5

   Visa, Travel & Accommodation

   Invitation letters, visa support, arrival logistics, extended-stay accommodation arranged.

6. 6

   On-Site Pre-Treatment Workup

   Repeat imaging, blood work, cardiac evaluation, and final eligibility confirmation.

7. 7

   Leukapheresis & Manufacturing

   T cells collected and sent for engineering. Bridging therapy if needed during this 2-4 week window.

8. 8

   Lymphodepletion & Infusion

   Short conditioning chemotherapy, then CAR T infusion (up to three doses in CT041-ST-01).

9. 9

   In-Hospital Monitoring

   1-2 weeks per infusion. CRS, infection, blood counts, and response watched closely.

10. 10

    Return Home & Follow-Up Handover

    Detailed summary handed to local oncology team with recommended monitoring schedule.

CLDN18.2 CAR T does not replace any existing line. It is a new option for selected patients after ≥2 prior systemic therapies have failed.

Explore related guides on gastric cancer, CAR T-cell therapy, and treatment access in China.

Frequently Asked Patient Questions

Common questions families ask when exploring Claudin 18.2 CAR T therapy.

Claudin 18.2 is one of two splice variants of the CLDN18 gene. The other variant, Claudin 18.1, is found mainly in normal lung tissue. CLDN18.2 is the gastric-specific variant and is normally limited to differentiated cells in the stomach lining. Two features make CLDN18.2 attractive as a therapeutic target. First, in normal tissue it sits inside tight junctions between cells, sealed off from the bloodstream and from circulating immune cells. Second, when malignant transformation disrupts the cell architecture, the protein becomes exposed on the surface of cancer cells. Therapies designed to recognize it can then bind and act, while sparing most normal tissues. Some CLDN18.2 expression remains in healthy stomach mucosa, which is one reason therapies targeting it can cause stomach-related side effects.