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Claudin18.2-specific CAR T cells in gastrointestinal cancers: phase 1 trial final results
Changsong Qi1, Chang Liu2, Jifang Gong3
1State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Beijing Key Laboratory of Carcinogenesis and Translational Research, Department of Early Drug Development Centre, Peking University Cancer Hospital & Institute, Beijing, China. changsongqi@bjmu.edu.cn.
Abstract:
Claudin18.2 (CLDN18.2) is highly expressed with the development of various malignant tumors, especially gastrointestinal cancers, and is emerging as a new target for cancer treatment. Satricabtagene autoleucel (satri-cel)/CT041 is an autologous chimeric antigen receptor (CAR) T cell targeting CLDN18.2, and the interim results of the CT041-CG4006 trial were reported in June 2022. Here we present the final results of this single-arm, open-label, phase 1 trial, which evaluated the safety and efficacy of satri-cel in patients with CLDN18.2-positive advanced gastrointestinal cancers. This trial included a dose-escalation stage (n = 15) and a dose-expansion stage in four different cohorts (total n = 83): cohort 1, satri-cel monotherapy in 61 patients with standard chemotherapy-refractory gastrointestinal cancers; cohort 2, satri-cel plus anti-PD-1 therapy in 15 patients with standard chemotherapy-refractory gastrointestinal cancers; cohort 3, satri-cel as sequential treatment after first-line therapy in five patients with gastrointestinal cancers; and cohort 4, satri-cel monotherapy in two patients with anti-CLDN18.2 monoclonal antibody-refractory gastric cancer. The primary endpoint was safety; secondary endpoints included efficacy, pharmacokinetics and immunogenicity. A total of 98 patients received satri-cel infusion, among whom 89 were dosed with 2.5 × 108, six with 3.75 × 108 and three with 5.0 × 108 CAR T cells. Median follow-up was 32.4 months (95% confidence interval (CI): 27.3, 36.5) since apheresis. No dose-limiting toxicities, treatment-related deaths or immune effector cell-associated neurotoxicity syndrome were reported. Cytokine release syndrome occurred in 96.9% of patients, all classified as grade 1-2. Gastric mucosal injuries were identified in eight (8.2%) patients. The overall response rate and disease control rate in all 98 patients were 38.8% and 91.8%, respectively, and the median progression-free survival and overall survival were 4.4 months (95% CI: 3.7, 6.6) and 8.8 months (95% CI: 7.1, 10.2), respectively. Satri-cel demonstrates therapeutic potential with a manageable safety profile in patients with CLDN18.2-positive advanced gastrointestinal cancer. ClinicalTrials.gov identifier: NCT03874897 .
Insights
Satricabtagene autoleucel (satri-cel) shows promise for CLDN18.2-positive gastrointestinal cancers. This CAR T-cell therapy demonstrated a manageable safety profile and therapeutic potential in advanced cases.
Area of Science:
- Oncology
- Immunotherapy
- Gastrointestinal Cancer Treatment
Background:
- Claudin18.2 (CLDN18.2) is a promising target in various cancers, particularly gastrointestinal malignancies.
- Chimeric antigen receptor (CAR) T-cell therapy offers a novel approach to cancer treatment.
Purpose of the Study:
- To evaluate the safety and efficacy of satricabtagene autoleucel (satri-cel), a CLDN18.2-targeting CAR T-cell therapy.
- To present final results from a Phase 1 trial (CT041-CG4006) in patients with CLDN18.2-positive advanced gastrointestinal cancers.
Main Methods:
- Single-arm, open-label, Phase 1 trial with dose-escalation and expansion stages.
- Enrolled 98 patients with CLDN18.2-positive advanced gastrointestinal cancers.
- Assessed safety, efficacy, pharmacokinetics, and immunogenicity of satri-cel.
Main Results:
- No dose-limiting toxicities or treatment-related deaths observed.
- Cytokine release syndrome (96.9%) and gastric mucosal injuries (8.2%) were manageable.
- Overall response rate of 38.8% and disease control rate of 91.8%.
- Median progression-free survival of 4.4 months and overall survival of 8.8 months.
Conclusions:
- Satri-cel exhibits therapeutic potential for CLDN18.2-positive advanced gastrointestinal cancers.
- The CAR T-cell therapy demonstrates a manageable safety profile in this patient population.
- Further investigation into satri-cel as a treatment for gastrointestinal cancers is warranted.
