Partial response (PR) was achieved according to RECIST v1.1, with great shrinkage of lung metastasis.
For case 2, a 75-year-old woman was diagnosed as pT2N0 pancreatic cancer after she underwent surgery in May 2019. Lung metastasis was found after 5 months during routine post-surgery follow-up. S-1 monotherapy was given as the first-line chemotherapy starting from December 2019. During the surgical area palliative radiation, tumor progression was observed in the lung. Since the CLDN18.2 expression was determined as 3+/60%, the patient was enrolled in CT041 clinical trial. After receiving lymphodepletion consisting of fludarabine, cyclophosphamide and nab-paclitaxel, the patient was infused with a CT041 dose of 250 × 106 cells in July 2021. Patient experienced grade 2 CRS, which was further controlled with tocilizumab. PR was reached since the first evaluation 4 weeks after infusion. Target lesions of lung metastasis subsequently disappeared and achieved complete response.
The tumor was still under well control until the last follow-up in July 2023. The peripheral blood CLDN18.2 CAR copy number in both patients exhibited a rapid post-infusion increase, peaking within 2 weeks. Concurrently, fluorescence-activated cell sorting results indicated an increase in peripheral blood CD8+ T cells and Treg cells, alongside a reduction in CD4+ T cells and B cells. These shifts in immune cell phenotypes demonstrated greater persistence compared to alterations in cytokine levels. Raffaele Baffa, MD, PhD, Chief Medical Officer of CARsgen Therapeutics, remarked that, "I am delighted to see the publication of two cases on our CT041's treatment of metastatic pancreatic cancer cases in the Journal of Hematology & Oncology. The fact that both patients achieved partial response after receiving CT041 infusion is truly encouraging. Pancreatic cancer remains one of the most challenging malignancies in the field of oncology, with extremely poor prognosis and limited treatment options. Therefore, the development of innovative therapy is crucial in providing hope to pancreatic cancer patients. Our preliminary data from the treatment of pancreatic cancer with CAR T-cell therapy indicate its potential in achieving significant anti-tumor responses, even in patients who have failed multiple previous treatment regimens. We believe that CT041 has the potential to transform the treatment landscape of pancreatic cancer and other solid tumors, offering new hope to patients and their families." CARsgen is a biopharmaceutical company with operations in China and the U.S. and is focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. CARsgen has established a comprehensive CAR T-cell research and development platform, encompassing target discovery, innovative CAR T-cell development, clinical trials, and commercial-scale production. CARsgen has internally developed novel technologies and a product pipeline with global rights to address major challenges of CAR T-cell therapies, such as improving the safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs. CARsgen's vision is to become a global biopharmaceutical leader that brings innovative and differentiated cell therapies to cancer patients worldwide and makes cancer curable. Forward-Looking Statements
All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, https://www.carsgen.com. No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release.
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