Adjuvant Satri-Cel Displays Preliminary Activity in Pancreatic Ductal Adenocarcinoma

The Claudin18.2 (CLDN18.2)–specific CAR T-cell therapysatricabtagene autoleucel (satri-cel; CT041) was active when used as adjuvant treatment in patients with pancreatic ductal adenocarcinoma (PDAC), according to data from a phase 1b trial (NCT05911217) presented during the 2025 ESMO Congress.1

At a median follow-up of 6.05 months (IQR, 4.04-8.38), the median disease-free survival (DFS) and overall survival (OS) among patients who received satri-cel (n = 6) were not reached. One patient experienced disease recurrence, and all other patients were still disease free at the data cutoff date of April 11, 2025. One patient who completed 52 weeks of follow-up after receiving satri-cel is still under follow-up without disease recurrence. Most patients (83.3%) experienced a significant decline in CA19-9 levels following satri-cel infusion; reductions ranged from 51.3% to 96.1%.

“In this preliminary analysis with a relatively limited sample size, satri-cel showed promising efficacy signals as adjuvant therapy for patients [with] PDAC, evidenced by significant reductions in CA19-9 levels in the majority of patients and encouraging long-term survival trends,” Xianjun Yu, MD, PhD, and coauthors, wrote in a poster of the data.

Yu is the chair of the Department of Pancreatic Surgery at Shanghai Cancer Center, the president of the Pancreatic Cancer Institute of Fudan University and the president of the Shanghai Pancreatic Cancer Institute, in China.

Previously, China’s National Medical Products Administration accepted a new drug application (NDA) seeking the approval of satri-cel in patients CLDN18.2-positive gastric/gastroesophageal junction cancer following disease progression on at least 2 prior lines of therapy.2

What Were the Key Design and Baseline Characteristics of the Phase 1b Study Examining Satri-Cel?

The phase 1b trial enrolled patients 18 to 79 years old with histologically confirmed PDAC.1,3 Patients were also required to have undergone macroscopic complete tumor removal (R0 or R1 resection), have postoperative pathological stage T1 to 3, N0 to 2, and M0 disease, and have a positive expression of CLDN18.2 of at least 2+ per immunohistochemistry. Abnormal CA19-9 levels following 3 months of standard adjuvant chemotherapy, no evidence of disease metastasis or local recurrence, and an ECOG performance status of 0 to 1 were also necessary for enrollment.

All patients received satri-cel at 250 × 106 cells after 3 months of adjuvant chemotherapy. Preconditioning lymphodepletion was comprised of fludarabine at 30 mg/m2 on days 1 to 3, cyclophosphamide at 250 mg/m2 on days 1 to 3, and nab-paclitaxel (Abraxane) at 100 mg on day 2. The primary end point was DFS. Secondary end points included 1-year DFS rate, safety, metastasis-free survival, OS, pharmacokinetics, and the immunogenicity of patients who received satri-cel.1,3

At baseline, the median age was 64.5 years (range, 51-71). Most patients were male (83.3%), had pT2 primary tumor status (66.7%), had R0 surgical margins (66.7%), and had high expression of CLDN18.2 (66.7%). All patients had an ECOG performance status of 1 and perineural invasion.

What Was the Safety Profile of Satri-Cel?

In terms of safety, all patients experienced grade 1 or 2 cytokine release syndrome (CRS) following the first infusion of satri-cel; 1 patient had grade 3 CRS after the second infusion but it resolved in 3 days after treatment with tocilizumab (Actemra). Four patients received tocilizumab as a treatment for CRS.

The most common any-grade treatment-emergent adverse effects (TEAEs) included pyrexia (100%), rash (100%), hyponatremia (100%), asthenia (100%), leukopenia (83.3%), neutropenia (83.3%), decreased weight (83.3%), vomiting (83.3%), and hypoalbuminemia (83.3%). Grade 3 or higher TEAEs included leukopenia (83.3%), hypokalemia (50.0%), and neutropenia (50.0%).

“No immune effector cell–associated neurotoxicity syndrome was reported,” Yu and his coauthors, wrote.

What Was Learned About the Pharmacokinetic Profile of Satri-Cel?

Additional findings from the study revealed that the median peak concentration of CAR copy numbers after the first satri-cel infusion was 7483 copies/µg of genomic DNA (range, 1120-50,800). The median time to reach maximum concentration was 10 days (range, 7-34) and the median persistence in peripheral blood was 24.5 days (range, 13-34).

Disclosures: Yu listed no relevant disclosures.

References

1. Yu X, Shi S, Zhang J, et al. Adjuvant therapy with claudin18.2-specific CAR T cells in high-risk pancreatic cancer (CT041-ST-05). Ann Oncol. 2025;36(suppl 2):S1234. doi:10.1016/j.annonc.2025.08.2837
2. CARsgen Therapeutics announces NDA acceptance of satri-cel by China’s NMPA. News release. CARsgen Therapeutics. June 26, 2025. Accessed November 13, 2025. https://www.carsgen.com/en/news/20250626/