CAR-T Therapy for Gastric Cancer

Claudin18.2 (CLDN18.2) is a tight junction protein isoform specifically expressed in gastric epithelium and highly overexpressed on the surface of gastric cancer cells. CT041 (development code CG4006) is an autologous CAR-T product targeting CLDN18.2. Phase I data show promising anti-tumor activity in heavily pretreated, CLDN18.2-positive gastric cancer patients.

HER2 overexpression is also seen in a subset of gastric cancer patients. HER2-targeted CAR-T therapies have demonstrated anti-tumor potential in preclinical and early clinical studies. Triumvira Immunologics’ TAC01-HER2 is currently in Phase II clinical trials.

• Highly Specific Targeting: By directing CAR-T cells against CLDN18.2 or HER2, gastric cancer cells can be precisely identified and eliminated, minimizing off-tumor effects.

• Overcoming Multiline Treatment Resistance: In CT041 trials, the gastric cancer cohort achieved an objective response rate (ORR) of 57.1%, disease control rate (DCR) of 75.0%, and a 6-month overall survival (OS) of 81.2% in patients who had failed multiple prior lines of therapy.

• Durable Responses: CLDN18.2-CAR-T treatment yielded a 6-month duration of response rate of 44.8%, suggesting potential for long-term clinical benefit.

• Personalized Therapy: Using the patient’s own T cells reduces the risk of rejection and enhances safety and efficacy.

• Peripheral Blood T-Cell Collection
  T cells are isolated from the patient’s peripheral blood via leukapheresis.

• Genetic Engineering
  In a GMP-compliant laboratory, T cells are transduced to express a CAR targeting CLDN18.2 or HER2, then expanded ex vivo.

• Lymphodepleting Conditioning
  A preparative regimen of cyclophosphamide and fludarabine is administered to deplete endogenous lymphocytes and create a favorable niche for CAR-T cell expansion.

• CAR-T Cell Infusion
  The engineered CAR-T cells are infused back into the patient intravenously.

• Monitoring and Management
  After infusion, patients are closely monitored for cytokine release syndrome (CRS) and neurotoxicity, with timely interventions as needed.

• CT041 (CLDN18.2-CAR-T) Phase I Interim Analysis
  Among 37 heavily pretreated patients, the gastric cancer subgroup achieved ORR 57.1%, DCR 75.0%; 94.6% experienced only Grade 1–2 CRS, with no Grade 3 or higher CRS or neurotoxicity; 6-month duration of response was 44.8%.

• Satri-cel (also targeting CLDN18.2) Phase I Final Results
  In 98 CLDN18.2-positive gastrointestinal cancer patients, ORR was 38.8%, DCR 91.8%; median progression-free survival (mPFS) was 4.4 months (95% CI 3.7–6.6), median overall survival (mOS) 8.8 months (95% CI 7.1–10.2); 96.9% experienced only Grade 1–2 CRS, with no Grade 3+ CRS or related deaths.

• HER2-CAR-T Early Clinical Data
  The first-in-human Phase I study demonstrated a manageable safety profile; a Phase II registration trial is ongoing.

• Leading Technology Platform
  BIOOCUS operates an international GMP-grade cell therapy manufacturing facility, ensuring efficient and consistent CAR-T cell production.

• Multidisciplinary Expert Team
  Our team includes seasoned specialists in immunology, oncology, and cell therapy, delivering fully personalized management.

• International Clinical Experience
  We have treated patients from around the globe, amassing extensive safety and efficacy data.

• Comprehensive End-to-End Service
  From protocol design and overseas treatment coordination to long-term post-infusion follow-up, BIOOCUS offers one-stop support.