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Proffered Paper session - Gastrointestinal tumours, non-colorectal

1372O - CLDN 18.2-targeted CAR-T cell therapy in patients with cancers of the digestive system

Date

19 Sep 2021

Session

Proffered Paper session - Gastrointestinal tumours, non-colorectal

Presenters

Changsong Qi

Citation

Annals of Oncology (2021) 32 (suppl_5): S1040-S1075. 10.1016/annonc/annonc708

Authors

C. Qi1, Y. Qin2, D. Liu1, J. Gong1, S. Ge3, M. Zhang1, Z. Peng1, J. Zhou1, X. Zhang3, X. Peng4, H. Wang5, C. He6, J. Xiao4, Z. Li5, L. Shen3

Author affiliations

  • 1 Department Of Gi Oncology, Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, 100142 - Beijing/CN
  • 2 Department Of Gi Oncology, The First Affiliated Hospital of Zhengzhou University, 450052 - Zhengzhou/CN
  • 3 Department Of Gi Oncology, Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, 100142 - Beijing/CN
  • 4 Medical Affairs, Clinical Development, CARsgen Therapeutics Co., Ltd, 100142 - Beijing/CN
  • 5 -, CARsgen Therapeutics Co., Ltd, 210000 - Shanghai/CN
  • 6 Biostatistician, Clinical Development, CARsgen Therapeutics Co., Ltd, 210000 - Shanghai/CN
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Resources

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Abstract 1372O

Background

Efficacy of chimeric antigen receptor-engineered T (CAR-T) cell therapy against solid tumors is still limited. CLDN18.2 is a promising target highly expressed in various cancer types of the digestive system. CT041, an anti-CLDN18.2 CAR-T cell therapy, showed promising anti-tumor activities in preclinical studies and an investigator-initiated study (CT041-CG4003 NCT03159819). This newly initiated phase I study was conducted to assess the safety and efficacy of CT041 produced with a modified manufacturing process.

Methods

Patients with CLDN18.2+ cancers of digestive system received CT041 at doses of 2.5×108, 3.75×108 or 5×108 CAR-T cells after preconditioning chemotherapy. The objective was to assess the safety, efficacy and cytokinetic profile of CT041.

Results

As of April 8, 2021, a total of 37 patients with cancer of digestive system, including 28 with gastric cancer (GC), 5 with pancreatic ductal adenocarcinoma (PDAC) and 4 with other cancer types, received CT041 infusion and completed at least 12 weeks of follow-up after the first infusion for the last subject. Cell doses of 2.5×108, 3.75×108 and 5×108 were administrated in 28, 6 and 3 patients, respectively. With a median follow-up of 7.6 months (95%CI 5.6, 8.6), all patients experienced ≥G3 hematologic toxicity while no DLT was observed. Immune effector cell-associated neurotoxicity syndrome, treatment-related death and ≥G3 cytokine release syndrome was not observed. The overall ORR for all patients and patients with GC were 48.6% (95%CI, 31.9%, 65.6%) and 57.1% (95%CI, 37.2, 75.5) respectively. At the dose level of 2.5×108, 18 patients with GC who have failed at least 2 prior lines of therapy including 44% (8/18) exposure to anti-PD-(L)1 antibody, the overall ORR, median PFS and OS was 61.1% (11/18), 5.4 months (95%CI, 2.6, NE) and 9.5 months (95%CI, 5.2, NE) respectively.

Conclusions

CT041 showed acceptable safety profile and promising anti-tumor activities in patients with refractory CLDN18.2+ cancers of digestive system. In patients with GC who have failed at least 2 prior lines of therapy, CT041 displayed a significantly improved efficacy compared to historical data.

Clinical trial identification

NCT03874897, first posted:March 14, 2019.

Editorial acknowledgement

Legal entity responsible for the study

Peking University Cancer Hospital & Institute.

Funding

CARsgen Therapeutics Co., Ltd.

Disclosure

C. Qi: Other, Personal and Institutional, Other, sub-investigator: CARsgen Therapeutics. Y. Qin: Other, Personal and Institutional, Principal Investigator: CARsgen Therapeutics. D. Liu: Other, Personal and Institutional, Other, sub-investigator: CARsgen Therapeutics. J. Gong: Other, Personal and Institutional, Other, sub-investigator: CARsgen Therapeutics. X. Peng: Financial Interests, Personal, Full or part-time Employment: CARsgen Therapeutics. H. Wang: Financial Interests, Personal, Full or part-time Employment: CARsgen Therapeutics. C. He: Financial Interests, Personal, Full or part-time Employment: CARsgen Therapeutics. J. Xiao: Financial Interests, Personal, Full or part-time Employment: CARsgen Therapeutics. Z. Li: Financial Interests, Personal, Full or part-time Employment: CARsgen Therapeutics. L. Shen: Other, Personal and Institutional, Principal Investigator: CARsgen Therapeutics. All other authors have declared no conflicts of interest.

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