Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-24 @ 1:35 PM
NCT ID:
NCT07066995
Brief Summary:
Autologous T-cells engineered to express CARs targeting Mesothelin and Claudin18.2, for Unresectable locally advanced or metastatic pancreatic adenocarcinoma (Pancreatic Ductal Adenocarcinoma, PDAC), administered as two separate sequential infusions following lymphodepleting chemotherapy
Detailed Description:
Pancreatic cancer is one of the most lethal malignancies, with a poor prognosis in advanced stages. Mesothelin (MSLN) and Claudin 18.2 (CLDN18.2) are tumor-associated antigens overexpressed in pancreatic adenocarcinoma cells. Both are promising immunotherapy targets, as they are prevalent in pancreatic tumors while largely restricted in normal tissues. CAR-T cell therapies directed at these antigens have shown early evidence of safety and anti-tumor activity. For example, mesothelin-specific CAR T cells have achieved stable disease and metabolic tumor regression in initial trials without dose-limiting toxicity. Similarly, CLDN18.2-specific CAR-T cells yielded objective remissions (including complete remission) in refractory pancreatic cancer, albeit with some gastric mucosal toxicity due to low-level target expression in normal stomach. Targeting two antigens may improve tumor control by addressing antigen heterogeneity and reducing immune escape. This trial evaluates a dual-target CAR-T strategy, in which two separate CAR-T products (one for mesothelin, one for claudin18.2) are given sequentially.
Study:
NCT07066995
Study Brief:
Protocol Section:
NCT07066995