Repeat Intravenous Infusions of B4T2-001 CAR-T Without Lymphodepleting Chemotherapy for Solid Tumors

This is an open-label, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of autologous B4T2-001 CAR-T 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). The trial builds off first-in-human results from pilot study per clinicaltrials.gov ID: NCT05621486 to administer multiple infusions of B4T2-001 CAR-T without the need to give preparative chemotherapy (lymphodepletion).

NCT Number	NCT06072989
Lead Sponsor	Shanghai East Hospital Collaborators: Bio4T2 LLC
Conditions	Advanced Solid Tumor
Enrollment	24 participants
Start Date	2023-10
Primary Completion	2025-03 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2023-10-10