Gastric cancer is one of the most common malignancies worldwide, and the disease burden in China is especially heavy. Although radical gastrectomy plays a central role in treatment, postoperative recurrence remains the key obstacle to long-term survival. Even after adjuvant therapy, patients with stage III gastric cancer who have undergone curative resection still carry a substantial risk of recurrence, with 1-year disease-free survival (DFS) of only 57%–75%. Persistent positivity for minimal residual disease (MRD) is an important driver of postoperative relapse. How to clear deeply hidden MRD and reduce the risk of late recurrence has become the central question in moving resectable stage III gastric cancer from prolonging survival toward pursuing cure.
In recent years, deeper research into the Claudin18.2 target has driven a landmark breakthrough for CAR-T therapy in solid tumors. China's independently developed satri-cel (CT041) was approved by the NMPA in June 2026 for Claudin18.2-positive, HER2-negative advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma after at least two prior lines of therapy, becoming the world's first approved CAR-T product for a solid tumor. On that foundation, investigators are actively extending its use into earlier lines and the perioperative setting.
At the 2026 Congress of the European Society for Medical Oncology (ESMO 2026), Prof. Qi Changsong of Peking University Cancer Hospital and Beijing GOBROAD Hospital presented, on behalf of the research team, the preliminary results of the phase Ib study of satri-cel as consolidation after adjuvant therapy in locally advanced G/GEJ adenocarcinoma (CT041-CG4010, NCT06857786). The study is the first to validate the safety and efficacy of CAR-T cell therapy in the postoperative adjuvant setting. It opens a new possibility for reducing recurrence and moving toward clinical cure in patients with gastric cancer after surgery, and marks a key step for solid-tumor CAR-T from late-line treatment toward the postoperative curative setting.
Study Design
CT041-CG4010 is a single-arm phase Ib study designed to evaluate the safety and efficacy of satri-cel as consolidation after adjuvant therapy following radical resection of G/GEJ adenocarcinoma. Eligible patients had Claudin18.2-positive disease (membrane staining intensity of at least 1+ in 70% or more of tumor cells) and locally advanced G/GEJ adenocarcinoma. Enrolled patients had undergone D2 gastrectomy with R0 resection and had pathological stage (y)pT4aN+ or (y)pT4bN any. Leukapheresis was performed in the interval between adjuvant treatment cycles, and patients received a single infusion of satri-cel (250 × 10⁶ cells) after completing the planned adjuvant therapy. The primary endpoint was safety; secondary endpoints included 12-month postoperative disease-free survival (M12 DFS rate), DFS, overall survival (OS), and pharmacokinetic characteristics.
Enrollment and Baseline Characteristics
As of the data cutoff on September 14, 2026, 10 patients had undergone leukapheresis and received satri-cel infusion. Claudin18.2 expression was high in 80% of patients (combined proportion of cells with 3+ and 2+ Claudin18.2 expression of 70% or more) and moderate in 20% (combined proportion 40% or more but less than 70%). The Lauren classification was diffuse in 90% and mixed in 10%; signet-ring cell carcinoma accounted for 70% and linitis plastica for 40%. By pathological stage, 90% were T4a and 10% were T4b, while 20% were N3a and 40% were N3b. Overall, this is a population with advanced pathological stage, high rates of lymph node metastasis, and aggressive histology — patients with heavy tumor burden and high recurrence risk.
Results
Safety: Generally Well Tolerated, CRS Mostly Low Grade, No ICANS Reported
In the safety analysis set, the most common treatment-related adverse event was cytokine release syndrome (CRS), reported in 80% of patients, of which 6 cases were grade 1 and 2 were grade 2 — all low-grade events. No immune effector cell-associated neurotoxicity syndrome (ICANS), treatment discontinuation, or death occurred, indicating that satri-cel consolidation after surgery is generally well tolerated.
Efficacy: M12 DFS Rate of 100%, Clear Potential for MRD Clearance
As of the data cutoff, 7 patients had completed 12-month postoperative (M12) follow-up, of whom 5 had completed M18 follow-up and 2 had completed M21 follow-up. With a median DFS follow-up of 12.0 months, the M12 DFS rate reached 100% and median DFS had not yet been reached. This means that within the current follow-up period, no patient who completed the M12 assessment experienced disease recurrence or death; the signal for postoperative disease-free benefit is clear, and with longer follow-up most patients remain in continuous disease-free survival.
Particularly noteworthy: one patient who tested ctDNA-positive before lymphodepletion converted to ctDNA-negative at the first follow-up after satri-cel infusion. ctDNA positivity generally indicates the presence of MRD that is difficult to detect by imaging, and this conversion directly supports the potential of satri-cel to clear residual tumor cells after surgery, allowing patients to achieve MRD clearance at the molecular level. For patients at high risk of postoperative recurrence, this suggests the therapy may not only delay imaging-visible relapse, but may also convert deep molecular remission into long-term disease-free benefit by eliminating MRD — the root of recurrence.
Pharmacokinetics: Rapid In Vivo Expansion and Persistence, Consistent With Sustained Antitumor Effect
Pharmacokinetic results further support these efficacy signals. After infusion, satri-cel expands rapidly in vivo, with median peak expansion on day 8, and remains detectable for approximately 2 weeks. This pattern indicates that the CAR-T cells have the potential for antigen-driven expansion and sustained immune killing, providing a mechanistic rationale for clearing Claudin18.2-positive minimal residual disease and dovetailing with the ctDNA conversion and DFS benefit.
Expert Commentary: From Late-Line Standard to First-Line Breakthrough and Perioperative Exploration
The preliminary positive results of CT041-CG4010 open a new direction for consolidation after adjuvant therapy in high-risk locally advanced G/GEJ adenocarcinoma, and mark a steady extension of satri-cel's use from late-line treatment of advanced gastric cancer toward the perioperative setting.
As the world's first approved CAR-T product for a solid tumor, satri-cel has already built a solid evidence base in advanced gastric cancer. In the late-line setting, the confirmatory CT041-ST-01 study demonstrated that, in patients with Claudin18.2-positive advanced gastric cancer who had failed at least two prior lines of therapy, satri-cel significantly improved objective response rate and prolonged median progression-free survival (PFS) and OS compared with the control group. After correction with the RPSFT model, patients treated with satri-cel achieved a median OS of 9.17 months, 5.2 months longer than those who did not receive it, establishing its standard position in late-line treatment. In the first-line advanced setting, cohort 3 of the CT041-CG4006 study (satri-cel maintenance after first-line induction therapy) showed an objective response rate of 100% in patients with measurable lesions and a median first-line PFS of 20.9 months — the first report of PFS exceeding 20 months in first-line treatment of gastric cancer with moderate-to-high Claudin18.2 expression. In addition, some patients successfully underwent conversion to surgery and achieved long-term survival, indicating that sequential satri-cel maintenance after first-line therapy may offer a potential chance of cure for some patients.
Building on this, CT041-CG4010 pushes the treatment line forward once more, moving the exploration from late-line and first-line settings to consolidation after postoperative adjuvant therapy. This exploration has three core clinical values.
First, it validates the safety and feasibility of CAR-T therapy in the perioperative setting for solid tumors. At present, CAR-T use in solid tumors is concentrated largely in late-line, refractory populations, and the perioperative setting is entirely new, with limited data on safety and tolerability. In this study, consolidation with satri-cel after postoperative adjuvant therapy was generally well tolerated, CRS was predominantly low grade, and no ICANS, treatment discontinuation, or death was reported. This indicates that, with adequate assessment and management, CAR-T can be safely applied in the perioperative setting, laying a solid clinical foundation for further exploration in perioperative treatment of solid tumors.
Second, deep clearance of MRD may offer a new path to cure for high-risk, potentially curable patients. For locally advanced gastric cancer — particularly high-risk groups such as T4 disease, diffuse type, and signet-ring cell carcinoma — MRD positivity is an important cause of recurrence after radical gastrectomy plus standard adjuvant therapy. Satri-cel has a mechanistic basis for clearing MRD. It recognizes the Claudin18.2 antigen on the tumor cell surface directly, independent of MHC molecules, which avoids immune escape through MHC downregulation. It kills potently, activating T cells through a CD28 co-stimulatory domain and CD3ζ signaling region, releasing perforin and granzyme, and inducing apoptosis through the Fas/FasL pathway. It expands in vivo, undergoing massive clonal expansion under antigen stimulation after infusion, amplifying the antitumor effect of a single dose and migrating into tumor tissue and peritoneal lesions. And it provides durable surveillance, forming memory CAR-T cells that survive long term in the body and can rapidly re-expand when residual tumor cells express the target antigen again, continuously clearing MRD and preventing recurrence. Together these four mechanisms give satri-cel the potential to clear gastric cancer MRD deeply. At the same time, the therapy offers the advantage of a single infusion with long-term survival benefit, allowing patients to live and work as they normally would without returning to hospital every 2 to 3 weeks, which markedly improves convenience, adherence, and quality of life. The encouraging efficacy data from this study further confirm that satri-cel can achieve deep molecular MRD clearance — as in the typical case of rapid ctDNA conversion — and bring the M12 DFS rate to 100%, providing preliminary validation of this mechanism in the clinic. In addition, compared with the high-burden late-stage setting, consolidation in the postoperative adjuvant phase, when tumor burden is lower and immune status better, offers greater potential for efficacy and safety advantages. This means that through a multidimensional sequential strategy — radical surgery to remove the tumor, adjuvant therapy to control it, and CAR-T to precisely clear minimal residual disease — we may be able to move some high-risk patients from the passive maintenance of long-term survival with tumor toward a clinical cure model of resection plus clearance, offering a new path to long-term disease-free survival and even cure.
Third, it completes the full-course management of Claudin18.2-positive gastric cancer, building a chain that runs from late-line to first-line to the perioperative setting. From establishing a standard in late-line treatment, to a breakthrough in first-line maintenance, to exploration of consolidation after postoperative adjuvant therapy, satri-cel is gradually covering the entire course of gastric cancer treatment and pushing Claudin18.2-positive gastric cancer into a new era of full-course management. This is, of course, a phase Ib study with a small sample size and short follow-up, and the preliminary results require further validation in larger populations with longer follow-up. Exploration of satri-cel in other Claudin18.2-positive solid tumors, including pancreatic cancer, is also advancing in parallel.
Overall, from late-line treatment to curative exploration in the perioperative setting, satri-cel continues to expand the therapeutic boundaries of CAR-T in solid tumors. As more evidence accumulates and treatment strategies are optimized, it may bring gastric cancer and other solid tumors into a new phase of deep MRD clearance in pursuit of clinical cure.
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This article summarises a conference presentation of an early-phase clinical study for general informational purposes only. It does not constitute medical advice, diagnosis, or treatment, and it describes an investigational use that may not be approved in your country. Please consult a qualified physician for any medical decision.