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A Clinical Study Evaluating the Safety and Efficacy of Anti-HER2-CAR-T Cells Injection in Patients With Solid Tumors

StatusRecruiting
PhasePhase 1
Started2024-01-16
View on ClinicalTrials.gov ↗

Amendment history

2024-03-05
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-10-25→confirmed 2024-01-16
Study sitesdetails revised at 1 of 1 site
2023-10-30
Study Identification, Study Status v1
Study title-55 characters
An ExploratoryA Clinical Study Evaluating the Safety and Efficacy of Anti-HER2-CAR-T Cells Injection in Patients With HER2+ Locally Advanced and/ or Metastatic Solid Tumors
2023-10-20
Original filing
This is a single-center, open-label clinical study of anti-HER2-CAR-T cells for HER2+ patients with locally advanced and/or metastatic solid tumors. In this study, a single-dose regimen was designed, and the investigator had the discretion to decide whether the patient received more than once CAR T-cell therapy.This study intends to include HER2+ patients with locally advanced and/or metastatic solid tumors.They will take the anti-HER2-CAR-T cell transfusion after a screening period, mononuclear cell (PBMC) collection, bridging therapy if necessary, and lymphocyte clearance pretreatment period.
Trial Details
NCT Number NCT06101082
Lead Sponsor China Medical University, China
Collaborators: Shanghai First Song Therapeutics Co., Ltd
Conditions Solid Tumor
Enrollment 9 participants
Start Date 2024-01-16
Primary Completion 2026-10-19 (estimated)
Study Completion 2026-10-19 (estimated)
Updated on ClinicalTrials.gov 2024-03-06