NCT05621486

A FIH, Single Arm, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Autologous CAR T Cells Targeting BT-001 in Patients With Advanced Solid Tumors

Study Summary

This is a first in human (FIH), open-label, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of B4T2-001 Autologous CAR T cells in subjects with advanced solid tumors including but not limited to advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma, advanced pancreatic cancer, advanced non-small cell lung cancer (NSCLC), colorectal cancers (CRC) and metastatic breast cancer that tests positive for BT-001 target antigen according to Immunohistochemistry (IHC).

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Interventions

B4T2-001 Autologous CAR T cellsBIOLOGICAL
Each subject will receive infusion with B4T2-001 autologous CAR T Cells

Study Locations

FacilityCityStateCountry
Shanghai East HospitalShanghaiChina/ShanghaiChina
Shanghai Artemed HospitalShanghaiChina/ShanghaiChina

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026