Clinical Trial of Autologous CD19 CAR-T Cells (CNCT19) Therapy for Advanced Hepatocellular Carcinoma

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZhejiang University

About this trial

A phase I clinical study of the safety and tolerability, efficacy of CNCT19 CAR T-cell therapy in patients with advanced hepatocellular carcinoma hepatocellular carcinoma.

Eligibility criteria

Qualifiers

Aged 18 to 80 years, male or female;

Subjects voluntarily participated in the research and signed the Informed Consent Form (ICF) by themselves or their guardians;

Pathologically diagnosed with hepatocellular carcinoma, patients with China liver Cancer Staging (CNLC) stageII-III.;

HCC patients who are not suitable for surgical resection or local treatment (including ablation therapy, interventional therapy, and radiation therapy), or who experience recurrence or progression after surgery and/or local treatment, and who have previously received at least second-line systematic standardized treatment and have progressed or are intolerant to it;

Disqualifiers

Active brain metastasis;

Patients who have received or are waiting for organ transplantation;

Active autoimmune diseases that require systemic immunosuppressive therapy within the past 2 years, such as systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, etc;

Researchers evaluated that the proportion of intrahepatic tumors is greater than 50% of the entire liver; Or there may be tumor thrombus formation in the main portal vein, or tumor thrombus invasion into the mesenteric vein/inferior vena cava;

Trial design

Treatments tested in this trial

  • anti-CD19 CAR-T

Treatment groups

12 Participants
are divided into 1 treatment group

Locations

2
First Affiliated Hospital, Medical College of Zhejiang University310003, HangzhouZhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine310000, HangzhouZhejiang, China

Sponsors and collaborators

Zhejiang University

Lead sponsor

Juventas Cell Therapy Ltd.

Collaborator