Hepatocellular Carcinoma Clinical Trial
Official title:
Clinical Study of Redirected Autologous T Cells With a Chimeric Antigen Receptor in Patients With Malignant Tumors
A single arm, open-label pilot study is designed to determine the safety, efficacy and
cytokinetics of CAR T cells in patients with malignant tumors with positive antigen targets.
CAR T cells are genetically engineered to express single-chain variable fragment (scFv)
targeting indication-specific antigens.
The investigational CAR T cells and proposed indications are as follows:
CAR-CD19 T cells for B cell leukaemia/lymphoma; CAR-BCMA T cells for myeloma; CAR-GPC3 T cell
for hepatocellular carcinoma; CAR-CLD18 T cells for pancreatic carcinoma and adenocarcinoma
of esophagogastric junction.
This study is designed to determine the safety, tolerability and engraftment potential of
lentivirus-transduced CAR T cells in patients with malignant tumors.
Primary objectives:
1. Determine the safety and tolerability of CAR T cells (autologous T cells transduced with
chimeric antigen receptors recognizing CD19, BCMA, GPC3 and Claudin18.2) in patients
with malignant tumors (B-cell lymphoblastic leukaemia/lymphoma, myeloma, hepatocellular
carcinoma, pancreatic carcinoma and adenocarcinoma of esophagogastric junction).
2. Observe the cytokinetics of CAR T cells.
Secondary objectives:
1. Observe the efficacy of CAR T cells in patients with malignant tumors.
2. Make an evaluation on the distribution and in vivo survival of CAR T cells in targeted
tissues.
3. Observe the immunogenicity of CAR T cells, and determine if there are anti-scFv cellular
immune response and anti-scFv humoral immune response.
4. Observe the changes of cell subsets for CAR T cells against T cells (Tcm, central memory
T lymphocytes; Tem, effector memory T lymphocytes; Treg, regulatory T-lymphocytes).
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