This is a single-center, open-label clinical study of anti-CEA-CAR-T cells for CEA+ 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 CEA+ patients with locally advanced and/or metastatic solid tumors.They will take the anti-CEA-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; Cytoplasmic and/or membranous high CEA expression in tumor tissue is required (expression intensity of 2+ and above on the area ≥50%) ;
Histology-confirmed solid tumors (gastric cancer, colorectal cancer, esophageal cancer, small bowel cancer, pancreas adenocarcinoma and other digestive system tumors are predominant), 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-CEA-CAR-T cell
Biological/VaccineAnti-CEA-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 0.3×10\^7 CAR-T cells/kg, 1×10\^7 CAR-T cells/kg, and 3×10\^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
First Hospital of China Medical University
Sponsor institution
Shanghai First Song Therapeutics Co., Ltd
Collaborator
