Status and phase
Conditions
Treatments
About
The purpose of this study is to observe and confirm the safety, tolerance and cell pharmacokinetics of lentivirus-transduced CAR-GPC3 T cells (CAR-GPC3 T cells targeting GPC3)
Full description
A single-center, open-label pilot study to determine the safety, tolerance and engraftment potential of CAR-GPC3 T cells in subjects with GPC3+ positive lung squamous cell carcinoma.
Primary objectives:
Observe and determine the safety and tolerance in escalating dose infusion of CAR-GPC3 T cells (CAR T cells targeting GPC3) transduced with the lentiviral vector, and the survival of the CAT-GPC3 T cells in vivo, referred to as engraftment potential.
Secondary objectives:
The following indexes are monitored for curative effect of CAR-GPC3 T cells on lung squamous cell carcinoma:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
CAR-T positive rate < 10%
pregnant women or women in lactation
active HBV or HCV infection
HIV/AIDS infection
active infection
previously suffered from diseases or concurrent diseases as followed:
during ongoing treatment using systemic steroid or steroid inhalants
previous treatment used gene therapy products
previous experience of immunotherapies including CIK, DC, DC-CIK, LAK for the treatment of cancer
allergic to immunotherapies or related drugs
patients in need of treatment for heart disease with ≥2 NYHA or for poor controlled hypertension
subjects with unstable or active peptic ulcer or alimentary tract hemorrhage
subjects with previous organ transplantation or ready for organ transplantation
subjects in need of anticoagulant therapy treatment (warfarin or heparin)
subjects judged by investigators as not appropriate for this study
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
Loading...
Central trial contact
Ruan Huaying, bachelor; Li Zonghai, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal