drugset / Trial / NCT03302403

Clinical Study of Redirected Autologous T Cells With a Chimeric Antigen Receptor in Patients With Malignant Tumors

NCT03302403

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2017-12-29
Primary completion
2020-12-12
Completion
2023-12-12

Drugs

EvaluationDrugModalityDoseRoute
Subject CAR-BCMA T cell Cell therapy Intravenous
Subject CAR-CD19 T cell Cell therapy Intravenous
Subject CAR-CLD18 T cell Cell therapy Intravenous
Subject CAR-GPC3 T cell Cell therapy Intravenous
Background Cyclophosphamide Other / unclassified
Background Fludarabine Small molecule