Safety and Early Effectiveness Study of BGT007H Cell Therapy for Adults With Recurrent or Resistant Gastrointestinal Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, and pharmacokinetics of BGT007H cell therapy in patients with recurrent or refractory gastrointestinal tumors. This early-phase, single-arm, open-label dose escalation study aims to determine the maximum tolerated or best effective dose of BGT007H and to explore its initial effectiveness. The study also investigates the relationship between BGT007H cell survival in the body and therapeutic effects, as well as target expression levels and efficacy. The treatment involves intravenous infusion of BGT007H cells at four escalating dose levels 1.0x108 cells, 3.0x108 cells, 1.0x109 cells, and 3.0x109 cells. Approximately 11 to 14 participants will be enrolled, with planned infusion of increasing doses to evaluate safety. Each participant receives a single intravenous infusion of BGT007H cells according to the assigned dose level. Participants will be monitored from the day of leukapheresis through 12 months after infusion to assess dose-limiting toxicities, adverse events, and other safety measures. Researchers will evaluate cancer lesions with standard criteria, perform pharmacokinetic assessments, and follow up periodically for safety and initial treatment response. The study is expected to last up to 12 months post-infusion for each participant, including safety monitoring and outcome evaluations.

BGT007H Cells for the Treatment of Recurrent/Refractory Gastrointestinal Tumors