The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Prospective inclusion of 1000 patients with pancreatic cancer (early-stage pancreatic cancer accounts for approximately 75% of cases), 1000 patients with benign pancreatic diseases, and 1000 healthy individuals as controls. Peripheral blood samples were collected from newly diagnosed pancreatic cancer patients and healthy individuals. Using techniques such as plasma TCR/BCR-seq, CyTOF, and plasma proteomics, multi-modal individual immune characteristics were obtained and analyzed along with clinical information. An artificial intelligence predictive model was built based on these multi-modal individual immune characteristics to establish an early screening technique for pancreatic cancer. The sensitivity and specificity of this artificial intelligence model for early pancreatic cancer diagnosis were evaluated using an external multicenter sample test set.

This is an investigator-initiated, single-center, open label, single-arm dose escalation study of XH001 (neoantigen tumor vaccine) in combination with sintilimab for advanced solid tumors. To evaluate the safety and tolerability of XH001 combined with sintilimab in subjects with advanced solid tumors, and preliminarily evaluate the efficacy of the combination therapy in subjects with advanced solid tumors.
The study will include pre-screening period (about 12 weeks), screening period (Weeks -4 to Day 1, and Week -1 to Day -1 will be baseline period), treatment period (Day 1 to Week 16 will be combination treatment period, followed by sintilimab monotherapy), and follow-up period. After signing pre-screening informed consent, tumor tissue and blood samples will be collected for gene sequencing, neoantigen prediction and vaccine preparation. During vaccine preparation, subjects will receive sintilimab (200mg, intravenous infusion, 21-day per cycle) or other antitumor therapy as deemed appropriate by the investigator. Subjects who sign and provide formal informed consent will enter the formal screening period, and qualified subjects will enter treatment period. During the treatment period, subjects will receive 6 cycles of XH001+ sintilimab, followed by sintilimab monotherapy (sintilimab will be administered for up to 18 cycles or for 1 year, whichever comes first).
The dose escalation phase follows standard 3+3 design. 9-12 subjects are expected to be enrolled at 2 given dose level.

This is a Phase 1, single-arm, single-center, open-label study to evaluate the safety and effectiveness of NKG2D/CLDN18.2-based CAR-T cells infusion in the treatment of advanced NKG2DL+/CLDN18.2+ solid tumors.