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.
Patients should understand and sign informed consent forms and voluntarily participate in clinical studies;
Age≥ 18, < 70 years old, gender is not limited;
Locally advanced and/or metastatic solid tumors; HER2-positive expression in tumor tissues (staining 3+, or staining 2+ with HER2 gene amplification should be further performed by ISH and other methods) ;
Histology-confirmed solid tumors (breast cancer,gastric cancer, colorectal cancer, pancreas cancer, etc.), conventional treatment is ineffective or Intolerability conventional treatment or lack of effective treatment;
Previously using any CAR-T cell products or other genetically modified T cell therapies;
Patients who are waiting for organ transplantation or with a history of allogeneic stem cell or solid organ transplantation;
Patients with acute or uncontrolled active infection, including but not limited to active tuberculosis;
Patients with Hepatitis B infection (HBV surface antigen positive and/or hepatitis B core antibody positive and hepatitis B DNA >10^3 copies /mL) ; hepatitis C infection(hepatitis C antibodies positive) ; Syphilis infection (antibody positive), HIV infection (antibody positive);
Single group
Intravenous infusion anti-HER2-CAR-T cell
Biological/VaccineAnti-HER2-CAR-T cell is administered as a single intravenous infusion. Follow-up infusions are based on the investigator's decision.The dose group to be infusion was 1×10\^6 CAR-T cells/kg, 3×10\^6 CAR-T cells/kg, and 1×10\^7 CAR-T cells/kg based on the 3+3 dose escalation principle. The infusion dose refers to the number of CAR-positive cells.
Dose-limiting toxicity
Dose-limiting toxicity
Objective response rate
Objective response rate
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China Medical University, China
Lead sponsor
Shanghai First Song Therapeutics Co., Ltd
Collaborator
