On June 22, China’s National Medical Products Administration (NMPA) approved Satricabtagene Autoleucel Injection (satri-cel, CT041), developed by Carsgen Therapeutics, for the treatment of patients with CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have failed at least two prior lines of systemic therapy.
This landmark approval makes CT041 the world’s first CAR-T cell therapy approved for a solid tumor indication, representing a historic breakthrough in the field of cellular immunotherapy. Until now, all approved CAR-T therapies worldwide have been used primarily for hematologic malignancies such as leukemia, lymphoma, and multiple myeloma.
A first-in-class CLDN18.2-targeted CAR-T therapy
CT041 is a first-in-class autologous humanized CAR-T cell therapy targeting Claudin 18.2 (CLDN18.2), a promising biomarker highly expressed in several gastrointestinal cancers, including gastric cancer and pancreatic cancer.
The therapy received Breakthrough Therapy Designation from China’s Center for Drug Evaluation (CDE) in March 2025, was granted Priority Review in May 2025, and achieved regulatory approval shortly thereafter.
The approval establishes CAR-T therapy as the second therapeutic modality, following monoclonal antibodies, to successfully target CLDN18.2 in gastric cancer. The target has attracted significant global interest, with dozens of clinical-stage programs under development.
Clinical trial results support approval
The approval was based on positive results from a pivotal Phase II clinical study (CT041-ST-01, NCT04581473) conducted in China among patients with advanced gastric or gastroesophageal junction adenocarcinoma.
The study findings were published in The Lancet and presented during the American Society of Clinical Oncology (ASCO) Annual Meeting.
Progression-free survival benefit
In the intent-to-treat (ITT) population, CT041 demonstrated a significant improvement in progression-free survival (PFS) compared with standard therapy:
- Median PFS: 3.25 months vs 1.77 months
- Hazard ratio (HR): 0.366
- 63% reduction in the risk of disease progression or death
Overall survival results also showed a favorable trend:
- Median overall survival (OS): 7.92 months vs 5.49 months
- Hazard ratio (HR): 0.693
Greater benefit in treated patients
Among patients who actually received treatment (modified ITT population):
- Median PFS: 4.37 months vs 1.84 months
- Hazard ratio: 0.304
- 70% reduction in risk of progression or death
Median overall survival reached:
- 8.61 months vs 5.49 months
- Hazard ratio: 0.601
- 40% reduction in mortality risk
Favorable safety profile
CT041 demonstrated a manageable safety profile consistent with CAR-T therapy.
Key safety findings included:
- Only four patients experienced Grade 3 cytokine release syndrome (CRS)
- No Grade 4 or Grade 5 CRS events reported
- No cases of immune effector cell-associated neurotoxicity syndrome (ICANS)
- Overall treatment was well tolerated
These findings are particularly encouraging given the historical challenges associated with applying CAR-T therapy to solid tumors.
Expanding into earlier-stage gastric cancer
Following this approval, Carsgen is actively investigating CT041 in earlier treatment settings.
Ongoing clinical studies in China include:
- Consolidation therapy after adjuvant treatment for gastric and gastroesophageal junction cancer
- Sequential therapy following first-line treatment in advanced gastric cancer
Researchers hope that moving CAR-T therapy into earlier disease stages may further improve patient outcomes.
Promising results in pancreatic cancer
Beyond gastric cancer, CT041 has also demonstrated encouraging activity in pancreatic cancer.
At the European Society for Medical Oncology (ESMO) Congress, investigators presented results from an ongoing Phase Ib registration study evaluating CT041 as adjuvant therapy for patients with resected pancreatic ductal adenocarcinoma (PDAC).
Eligible patients were:
- CLDN18.2-positive
- Had undergone curative surgery
- Completed at least three months of adjuvant chemotherapy
- Showed elevated CA19-9 levels without radiographic evidence of recurrence
Among six treated patients:
- Only one patient experienced disease recurrence during follow-up
- Five patients remained disease-free
- Nine-month disease-free survival rate reached 83.3%
- Median disease-free survival and overall survival had not yet been reached
- Five patients experienced significant reductions in CA19-9 tumor marker levels, ranging from 51.3% to 96.1%
These early findings suggest that CT041 may have potential beyond advanced disease and could play a role in preventing cancer recurrence.
A milestone for CAR-T therapy and solid tumor treatment
The approval of CT041 marks a major milestone not only for Carsgen Therapeutics but also for the global cell therapy industry.
For decades, researchers have sought to replicate the success of CAR-T therapy in blood cancers within solid tumors. The approval of CT041 demonstrates that this goal is achievable and may open the door to a new generation of cellular therapies targeting gastric cancer, pancreatic cancer, and other solid malignancies.
As additional studies mature and new indications are explored, CT041 may become one of the most important advances in solid tumor immunotherapy in recent years.
Learn more about CAR-T therapy in China
Gene Medical helps international patients explore advanced CAR-T cell therapy programs available in China. Our team provides treatment information, medical record review, hospital matching, travel coordination, and ongoing patient support throughout the treatment journey.
Contact Gene Medical to learn whether CAR-T therapy may be an option for your condition.