...Phase Ib：Tumor tissue samples were positive for CLDN18.2 IHC staining； Phase II：Tumor tissue samples were positive for CLDN18.2 IHC staining and HER2 expression was negative; 5....

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...the safety, tolerability and efficacy of CT041 in patients with previously treated, CLDN18.2-positive advanced G/GEJ cancer...As of the data cut-off, 8 of 14 (57.1%) patients achieved partial response (PR); 2 of 14 (14.3%) patients showed stable disease (SD). With a median follow-up time of 8.9 months (95%CI 5.91, NE), the median progression-free survival (PFS) was 5.6 months (95%CI 1.9, 7.4), and median overall survival (OS) was 10.8 months (95%CI 5.1, NE) with 7 patients still alive at last follow-up....These preliminary results suggest that CT041 had manageable safety/tolerability profile and promising efficacy in patients with previously treated advanced G/GEJ cancer.

The overall response rate (ORR) and disease control rate (DCR) reached 48.6% and 73.0%, respectively. The 6-month duration of response rate was 44.8%. In patients with GC, the ORR and DCR reached 57.1% and 75.0%, respectively, and the 6-month overall survival rate was 81.2%. These initial results suggest that CT041 has promising efficacy with an acceptable safety profile in patients with heavily pretreated, CLDN18.2-positive digestive system cancers, particularly in those with GC.

...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...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. 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.

The in vitro repeat killing assay demonstrated strong and persistent anti-tumor activity of CLDN18.2-TAC T cells against CLDN18.2 expressing target cells. Lastly, treatment with CLDN18.2-TAC T cells in MHC DKO mice bearing CLDN18.2-positive tumors led to complete and sustained tumor clearance...The in vitro and in vivo data confirm strong and specific activity of CLDN18.2-targeted TAC T cells against CLDN18.2-expressing solid tumor models and highlight the versatility of the TAC platform for therapeutic applications in solid tumors.