A phase I study of Satri-cel, a Claudin18.2-targeted autologous CAR-T cell therapy, has been published in the internationally recognized journal Journal of Hematology & Oncology.
The study reported three cases of patients with advanced gastric cancer with peritoneal metastasis who achieved long-term disease control after treatment with Satri-cel. The longest follow-up reached 48 months, providing encouraging evidence for a patient population with extremely limited treatment options.
Gastric cancer with peritoneal metastasis remains one of the most difficult forms of advanced gastric cancer to treat. Patients typically have a poor prognosis, with median survival historically reported at only 3–6 months after diagnosis of peritoneal dissemination. New treatment strategies are urgently needed for these patients.
Claudin18.2 (CLDN18.2), a membrane protein highly expressed in many gastric cancers, has emerged as a promising target for precision cancer therapy. Studies have shown that CLDN18.2-positive gastric cancer is associated with a higher incidence of peritoneal metastasis, making it an attractive target for CAR-T cell therapy.
Three Patients Achieved Durable Control of Peritoneal Metastases
The Phase I study included three patients with CLDN18.2-positive advanced gastric cancer and peritoneal metastasis. All patients received Satri-cel monotherapy and achieved clinical benefits, including tumor reduction and prolonged control of abdominal disease.
Patient 1: Complete Control of Peritoneal Disease and Successful Conversion Surgery
A 53-year-old woman was diagnosed with gastric cancer with peritoneal and lymph node metastases. After receiving first-line chemotherapy and intraperitoneal chemotherapy, she underwent Satri-cel treatment in December 2021.
Four weeks after infusion, the patient achieved a partial response (PR), with significant shrinkage of peritoneal nodules.
Eight months after treatment, laparoscopic examination showed no visible peritoneal metastases. The patient’s Peritoneal Cancer Index (PCI) score decreased from 9 before treatment to 0, allowing her to undergo total gastrectomy with D2 lymph node dissection.
Postoperative pathology showed ypT2N0 disease.
During follow-up, bilateral ovarian metastases were detected and surgically removed. No further disease progression was observed afterward.
As of the last follow-up on January 6, 2026, the patient had maintained control of peritoneal metastasis for 48 months.
Patient 2: Overall Survival Reached 44 Months
A 53-year-old woman underwent radical distal gastrectomy and adjuvant chemotherapy in 2019. Disease recurrence was confirmed in June 2021, with metastases involving the pelvis, abdominal wall, and appendix.
After first-line chemotherapy, she received Satri-cel treatment in December 2021.
Four weeks after infusion, imaging showed partial response, with reduced peritoneal lesions.
Following ovarian metastasis recurrence in June 2022, she received a second Satri-cel infusion and underwent bilateral salpingo-oophorectomy. During surgery, no visible peritoneal dissemination was observed (PCI = 0), despite previous pelvic, abdominal wall, and ovarian involvement.
She received a third Satri-cel infusion in September 2023.
At the last follow-up on August 26, 2025, the patient remained alive, with overall survival reaching 44 months.
Patient 3: Significant Symptom Relief and Survival of 35 Months
A 48-year-old woman underwent palliative distal gastrectomy, multi-organ resection, and intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) in 2019.
After multiple lines of treatment failed, she received Satri-cel infusion in December 2021.
Following treatment, symptoms including abdominal distension and intestinal obstruction improved significantly, while tumor lesions also decreased.
In May 2022, ovarian metastases were surgically removed. No visible peritoneal nodules were found during surgery (PCI = 0), compared with five affected sites before CAR-T treatment (PCI = 15).
The patient subsequently received two additional Satri-cel infusions and achieved an overall survival of 35 months.
Favorable Safety Profile Observed
The three patients tolerated Satri-cel treatment well.
During treatment and follow-up:
- No immune effector cell-associated neurotoxicity syndrome (ICANS) was observed.
- No Grade ≥3 cytokine release syndrome (CRS) occurred.
- No severe treatment-related safety events were reported.
These findings suggest that Satri-cel may offer a manageable safety profile in patients with advanced gastric cancer.
CAR-T Cells Persisted in Tumor Tissues
Researchers also analyzed CAR-T cell persistence in blood and tumor samples.
Although CAR-T cell levels in peripheral blood peaked around day 10 after infusion and became nearly undetectable around day 30, CAR-T cells were still detected months later in tumor tissues.
CAR-T cell infiltration was observed in:
- Gastric tumor tissue collected 8 months after infusion (Patient 1)
- Ovarian metastatic tissue collected 13 months after infusion (Patient 1)
- Ovarian tissue collected 7 months after infusion (Patient 2)
- Ovarian tissue collected 5 months after infusion (Patient 3)
These findings suggest that Satri-cel can migrate into tumor tissues and persist locally, which may contribute to its ability to achieve long-term control of peritoneal metastases.
Previous studies have also shown that ascites from gastric cancer patients often maintains stable and high CLDN18.2 expression, and CAR-T cell expansion in ascites may be stronger than in peripheral blood.
This ability to enter the abdominal cavity and remain active within tumor tissues may represent one of the key reasons why Satri-cel achieved durable responses in patients with peritoneal metastasis.
A New Hope for Patients with Advanced Gastric Cancer
The long-term follow-up results from these three patients highlight the potential of Claudin18.2-targeted CAR-T therapy as a new treatment approach for advanced gastric cancer, especially for patients with peritoneal metastasis who currently have limited options.
With follow-up reaching up to 48 months, these outcomes are significantly longer than historical survival expectations for gastric cancer patients with peritoneal dissemination.
Satri-cel represents one of the most advanced CAR-T approaches being developed for solid tumors and may open a new chapter in the treatment of CLDN18.2-positive gastric cancer.
CARsgen Therapeutics continues to advance clinical research on Satri-cel and explore its applications in additional CLDN18.2-positive solid tumors.
