An Open-label, Uncontrolled, Single-arm Pilot Study to Evaluate Vascular Interventional Therapy Mediated GPC3-targeted Chimeric Antigen Receptor T Cells in Advanced Hepatocellular Carcinoma (GPC3-CART)

NCT02715362 Phase 1/Phase 2 UNKNOWN

Intravenous infusion of CART cells in the treatment of solid tumors may be not a suitable choice. Because by intravenous infusion, T cells first entered into the blood circulation, but the number of T cells accumulated at the tumor site is limited, while the probability is high that CART cells contact with normal tissue where target protein is expressed, leading to a more potential off-target side effect. In this study, CART cells infused to the body is mediated by the method of transcatheter arterial infusion(TAI), which is one kind of tumor intervention therapy pathway. We hope by this means could improve the local CAR-T cell numbers，meanwhile reduce the potential side effects.

Details

Lead sponsor	Shanghai GeneChem Co., Ltd.
Phase	Phase 1/Phase 2
Status	UNKNOWN
Enrolment	30
Start date	2016-03
Completion	2019-03

Conditions

• Carcinoma, Hepatocellular

Interventions

• TAI-GPC3-CART cells

Primary outcomes

• Safety of CAR-T cell infusion mediated by TAI as measured by number of participants with adverse Events — 6 weeks
  To determine the safety and regimen limiting toxicity (RLT) of anti-GPC3 CAR-T transcatheter arterial infusion (TAI) for GPC3-expressing HCC.

Countries

China