CT011 Autologous CAR-T Cells in Patients With Hepatocellular Carcinoma at Risk of Recurrence After Surgical Resection

ConditionHCC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCARsgen Therapeutics Co., Ltd.

About this trial

A Single-arm, Open-label, Multicenter, Phase Ib Clinical Trial to Evaluate the Safety and Efficacy of CT011 Autologous CAR-T Cells in Patients with Hepatocellular Carcinoma at Risk of Recurrence after Surgical Resection.

Eligibility criteria

Qualifiers

Volunteer to participate in the clinical trial; fully understand and are informed of this trial and sign the informed consent form; Willing to follow and able to complete all trial procedures;

Age 18-75 years, inclusive, male or female;

Portal vein tumor thrombus (PVTT);

Hepatic vein tumor thrombus (HVTT);

Disqualifiers

Known fibrolamellar HCC, sarcomatoid HCC, or mixed hepatocellular-cholangiocarcinoma;

Intrahepatic recurrence or extrahepatic metastasis, or residual hepatocellular carcinoma detected before apheresis (imaging evidence according to RECIST v1.1);

More than 2 years since surgical resection;

Pregnant or lactating females;

Trial design

Treatments tested in this trial

  • CT011 CAR-GPC3 T Cells Injection

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

CARsgen Therapeutics Co., Ltd.

Lead sponsor

Shanghai Zhongshan Hospital

Collaborator