Clinical Study of Redirected Autologous T Cells With a Chimeric Antigen Receptor in Patients With Malignant Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 48
Summary
- Conditions
- Adenocarcinoma of Esophagogastric Junction
- B Cell Leukemia
- B Cell Lymphoma
- Hepatocellular Carcinoma
- Myeloma
- Pancreatic Carcinoma
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
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: Determine the safety and tolerability of CAR T cells (autologous T cells transduced with chimeric antigen receptors recog...
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: 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). Observe the cytokinetics of CAR T cells. Secondary objectives: Observe the efficacy of CAR T cells in patients with malignant tumors. Make an evaluation on the distribution and in vivo survival of CAR T cells in targeted tissues. Observe the immunogenicity of CAR T cells, and determine if there are anti-scFv cellular immune response and anti-scFv humoral immune response. 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).
Tracking Information
- NCT #
- NCT03302403
- Collaborators
- Carsgen Therapeutics, Ltd.
- Investigators
- Principal Investigator: Mengtao Zhou, MD First Affiliated Hospital of Wenzhou Medical University Principal Investigator: Kang Yu, MD First Affiliated Hospital of Wenzhou Medical University Principal Investigator: Songfu Jiang, MD First Affiliated Hospital of Wenzhou Medical University
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