CLDN18.2-directed Solid tumor program

Satri-cel

Satricabtagene autoleucel

A CLDN18.2-directed CAR T-cell therapy for advanced gastric and gastroesophageal junction cancer that has progressed after previous treatment. It is made from a patient's own immune cells, re-engineered to recognize CLDN18.2, a protein that can sit on the surface of gastric cancer cells.

Also known as Satri-cel · a CLDN18.2-directed, autologous CAR T-cell therapy

Start with the tests you'll need
What it is

A therapy made from your own cells.

A plain-language look at what satri-cel is and how it works — general to this class of therapy, not a claim about any one patient's result.

Satricabtagene autoleucel — satri-cel for short — is a type of CAR T-cell therapy. A patient's own T-cells are collected, then re-engineered to recognize a protein called CLDN18.2 that can be present on the surface of gastric and gastroesophageal junction cancer cells. Once returned to the body, these modified cells seek out and act against cells carrying that protein.

Satri-cel was approved in China by the NMPA on 16 June 2026. That approval is category-level information about the medicine.

It is an autologous therapy, meaning it is made from a patient's own cells rather than a donor's. Unlike the CD19- and BCMA-directed therapies used for blood cancers, satri-cel is directed at a solid-tumor target — which is why it sits in its own program, with its own pathway.

Approved indication

NMPA · verbatim label

This product is indicated for the treatment of patients with CLDN18.2-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced gastric or gastroesophageal junction adenocarcinoma (G/GEJA) who have failed at least two prior lines of therapy.

Eligibility depends on your specific diagnosis — a physician decides.

Before you can be assessed

Two tests decide whether an assessment is even possible yet.

Satri-cel is directed at CLDN18.2 and is considered only when a tumor is CLDN18.2-positive and HER2-negative. Both results are needed before an assessment can begin — and many patients won't have had them, because these tests aren't routine everywhere. Without them, there is nothing yet to assess.

Done in your home country, not in Shanghai Completed before you travel
CLDN18.2 A tumor-tissue test showing whether the cancer carries the target satri-cel is directed at. It must be positive.
HER2 A separate tumor-tissue test. For this pathway the result must be negative.
Who it's for

Where satri-cel may be an option.

The approved indication is stated plainly here. Whether treatment is possible is decided by the treating CAR-T team after reviewing your records and pathology.

Assessed after home testing

Advanced gastric cancer

Read about advanced gastric cancer at SinoUnited

The following information is for reference only. Final treatment decisions should be made by a qualified physician based on each patient's individual condition.

  • Diagnosis — advanced gastric or gastroesophageal junction adenocarcinoma.
  • CLDN18.2 — positive, confirmed by a validated test.
  • HER2 — negative.
  • Prior treatment — at least two prior lines of therapy.
  • Well enough for treatment — as assessed by the medical team.

If you don't know your CLDN18.2 status, it is found by a test on your tumor tissue — so keep your tissue blocks. Without stored tissue, testing may not be possible. Your records and pathology can be reviewed before you travel; overseas pathology is accepted.

The treatment course

A course of one to three infusions.

This is not the single-infusion pathway described elsewhere on this site. It starts before you travel, and should be planned in months, not weeks.

Step zero

Testing at home

CLDN18.2 and HER2 results, on tissue, before anything else can be planned.

Your home country
01

First infusion

Infusions are given one at a time. Each means roughly two weeks as an inpatient, and about four weeks nearby afterwards.

Shanghai
02

Assessment at about four weeks

The disease is reassessed after the first infusion, and how well that infusion was tolerated is reviewed.

Shanghai
03

A further infusion, if indicated

Considered only if the disease has not progressed and the previous infusion was well tolerated. Up to three in total.

Shanghai

Because a course may run to three infusions, travel, accommodation and time away should be planned in months. The blood-cancer timeline described elsewhere on this site does not apply here. Scheduling for this program is arranged case by case.

Therapy & condition

One therapy, one condition.

In this program the relationship is one-to-one — a single therapy directed at a single condition, joined by the CLDN18.2 target.

The therapy

Satri-cel

Satricabtagene autoleucel

A CLDN18.2-directed, autologous CAR T-cell therapy, approved by China's NMPA on 16 June 2026. It is offered at SinoUnited Health's CAR T-Cell Therapy Center in Shanghai.

The condition

Advanced gastric cancer

Gastric & GEJ adenocarcinoma

Cancer of the stomach or gastroesophageal junction, in patients whose disease is CLDN18.2-positive and HER2-negative.

About advanced gastric cancer

Unlike the blood-cancer set — where a condition may be treated by more than one therapy and a therapy may treat more than one condition — this pairing is exact. It is presented as a pair, not as a single entry in a grid built for many.

The named physician

Dr. Haiyan Yang

Dr. Haiyan Yang, M.D., Ph.D. · Medical Oncologist · SinoUnited Health

Dr. Yang is the named physician for the solid tumor program at SinoUnited Health's CAR T-Cell Therapy Center in Shanghai. This program is separate from the hospital's blood-cancer CAR-T program, and no evidence, publication, patient volume or outcome from that program is presented here.

The medical team
Dr. Haiyan Yang, Medical Oncologist, SinoUnited Health
Dr. Haiyan Yang, M.D., Ph.D. Medical Oncologist · SinoUnited Health
Common questions

Questions we're asked most.

Answers about the target, the testing, the course and what to keep.

What is CLDN18.2, and how do I know if I'm positive?

CLDN18.2 is a protein found on the surface of some gastric and gastroesophageal junction cancers, and it is the target satri-cel is directed at. Status is confirmed by a validated test on tumor tissue. It isn't part of every standard workup, so many people do not know their status — if you have had a biopsy or surgery, ask the hospital that took the sample to keep the tissue.

What does HER2-negative mean here?

The approved indication covers HER2-negative disease only. If your cancer is HER2-positive, satri-cel is not indicated for you — HER2-positive gastric cancer has its own targeted treatments, which your treating team can discuss with you.

How many infusions are needed?

A course is one to three infusions, given one at a time. There is an assessment at about four weeks after the first infusion, and a further infusion is considered only if the disease has not progressed and the previous infusion was well tolerated.

What tissue do I need to keep?

The stored tissue block from an earlier biopsy or surgery. Both CLDN18.2 and HER2 testing are run on tumor tissue, so without a block the tests may not be possible. Ask the hospital that took the sample to retain it, and keep your pathology reports and treatment history with it.

What are the side effects?

The approved product information carries a boxed warning: CAR T-cell therapy can cause cytokine release syndrome (CRS) and nervous system toxicity, which can be severe or life-threatening, and names tocilizumab and corticosteroids for severe CRS. That is general information about this class of therapy. Separately, at SinoUnited Health, treatment is given as a supervised inpatient stay with on-site intensive care available and tocilizumab available on site.

The first step

Ready to find out if satri-cel is an option?

The first step is a remote assessment by the CAR-T team — but it can only begin once your two biomarker results are in hand.

Before you inquire

Have your CLDN18.2 and HER2 test results from home ready. Without both, an assessment can't start yet — so getting tested is the very first thing to do.