Clinical Study of Redirected Autologous T Cells With a Chimeric Antigen Receptor in Patients With Malignant Tumors
NCT03302403 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2020-10-08
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.
Conditions
- B Cell Lymphoma
- B Cell Leukemia
- Myeloma
- Hepatocellular Carcinoma
- Pancreatic Carcinoma
- Adenocarcinoma of Esophagogastric Junction
Interventions
- GENETIC
-
CAR-CD19 T cell
Self-controlled dose escalation and classic "3+3" dose escalation will be applied.
- GENETIC
-
CAR-BCMA T cell
Self-controlled dose escalation and classic "3+3" dose escalation will be applied.
- GENETIC
-
CAR-GPC3 T cell
Self-controlled dose escalation and classic "3+3" dose escalation will be applied.
- GENETIC
-
CAR-CLD18 T cell
Self-controlled dose escalation and classic "3+3" dose escalation will be applied.
- DRUG
-
Fludarabine is used for lymphodepletion.
- DRUG
-
Cyclophosphamide is used for lymphodepletion.
Sponsors & Collaborators
-
CARsgen Therapeutics Co., Ltd.
collaborator INDUSTRY -
Kang YU
lead OTHER
Principal Investigators
-
Mengtao Zhou, MD · First Affiliated Hospital of Wenzhou Medical University
-
Kang Yu, MD · First Affiliated Hospital of Wenzhou Medical University
-
Songfu Jiang, MD · First Affiliated Hospital of Wenzhou Medical University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-12-29
- Primary Completion
- 2020-12-12
- Completion
- 2023-12-12
Countries
- China
Study Locations
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