Clinical Trial

A Clinical Study to Evaluate B4T2-001 CAR T Cells in the Treatment of Advanced Solid Tumors

Active, Not Recruiting Phase 1
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Record status
This record was last updated October 12, 2023 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2022-11-17.
Status change: Recruiting → Active, Not Recruiting 2023-10-10
Trial Details
NCT Number NCT05621486
Lead Sponsor Shanghai East Hospital
Collaborators: Bio4T2 LLC
Conditions Advanced Solid Tumor
Enrollment 36 participants
Start Date 2022-09-14
Primary Completion 2024-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2023-10-12