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Clinical Trial Summary

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.


Clinical Trial Description

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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03302403
Study type Interventional
Source First Affiliated Hospital of Wenzhou Medical University
Contact
Status Active, not recruiting
Phase N/A
Start date December 29, 2017
Completion date December 12, 2023

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