A new type of personalized cell therapy is showing encouraging results for people with advanced stomach (gastric) or gastro-oesophageal junction (GEJ) cancer who have already tried standard treatments.
Researchers in China reported results from a phase II study that a therapy called satricabtagene autoleucel (satri-cel), a type of CAR T-cell therapy designed to target a protein called CLDN18.2, helped patients live longer without their disease worsening. The findings come from the CT041-ST-01 trial, the first randomized study of CAR T-cell therapy in solid tumors worldwide.
What the Study Found
- The trial enrolled 156 patients with advanced CLDN18.2-positive gastric or GEJ cancer, most of whom had already been through at least two prior treatments.
- Patients received either satri-cel or a standard drug chosen by their doctor.
- Progression-free survival (PFS) – the length of time before the cancer grew or spread – was longer with satri-cel:
- 3.25 months with satri-cel
- 1.77 months with standard treatment
- Overall survival (OS) – the length of time patients lived after starting treatment – was also improved:
- 7.9 months with satri-cel
- 4.4 months with standard treatment
- Some patients who started with standard treatment later crossed over to satri-cel and also saw experienced survival.
Safety Considerations
Like other CAR T-cell therapies, satri-cel comes with risks. Nearly all patients experienced side effects such as low blood counts and cytokine release syndrome (CRS), a reaction common with CAR T therapy. Doctors noted that although serious, these side effects were generally manageable with proper care at experienced centers.
Why This Matters
For patients with stomach or GEJ cancer that has come back after multiple treatments, options have been extremely limited. Most existing treatments combine chemotherapy with targeted drugs, often leading to cumulative side effects over time.
This trial suggests satri-cel might offer a new, non-chemotherapy option for CLDN18.2-positive patients. Importantly:
- About 40–60% of patients with gastric or GEJ cancer may have tumors that express CLDN18.2, making them potentially eligible.
- Satri-cel is still experimental and only tested so far in China, so more global research is needed.
Expert Commentary
Independent experts praised the study as a major step forward but also warned of several challenges:
- The trial only included Chinese patients, so results may differ in Western populations.
- Doctors need clearer standards worldwide for testing CLDN18.2 positivity.
- Because CAR T treatments are complex and potentially toxic, they must be given at specialized cancer centers.
This study offers the first strong evidence that CAR T-cell therapy may benefit patients with advanced gastric or GEJ cancer who have run out of other options. While still experimental and not yet available outside of clinical trials, it represents an important step toward expanding the use of CAR T beyond blood cancers into solid tumors like stomach cancer.
Patients interested in CLDN18.2-targeted therapies (including CAR T and antibody treatments such as zolbetuximab) should ask their oncologist whether their tumor can be tested for CLDN18.2 expression and whether clinical trials may be available.
More Reading
CAR T Cell Therapy for Treatment of Solid Tumors
References
Qi C, Liu C, Peng Z, Zhang Y, et al. Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) versus treatment of physician’s choice for previously treated advanced gastric or gastro-oesophageal junction cancer (CT041-ST-01): a randomised, open-label, phase 2 trial . The Lancet 2025;405(10494):P2049-2060.
Qi C, Liu C, Peng Z, et al. Claudin18.2-specific CAR T cells (Satri-cel) versus treatment of physician’s choice (TPC) for previously treated advanced gastric or gastroesophageal junction cancer (G/GEJC): Primary results from a randomized, open-label, phase II trial (CT041-ST-01) . J Clin Oncol 2025:43:(suppl 16):abstr 4003.DOI: https://doi.org/10.1200/JCO.2025.43.16_suppl.4003
Ghidini M, Tomasello G. CAR T-cell therapy in advanced gastro-oesophageal cancer . The Lancet 2025;405(10494):P2024-2025.
