Spots Global Cancer Trial Database for A Phase I Study Evaluating Safety and Efficacy of C-CAR011 Treatment in Adult Subjects With r/r CD19+B-ALL

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Trial Identification

Brief Title: A Phase I Study Evaluating Safety and Efficacy of C-CAR011 Treatment in Adult Subjects With r/r CD19+B-ALL

Official Title: A Phase I Study Evaluating Safety and Efficacy of CBM.CD19-targeted Chimeric Antigen Receptor T Cells (C-CAR011) Treatment in Adult Subjects With Relapsed/Refractory CD19+ B Cells Acute Lymphoblastic Leukemia(CALL-1)

Study ID: NCT03018093

Conditions

Relapsed or Refractory Acute Lymphoblastic Leukemia

Interventions

C-CAR-011

Study Description

Brief Summary: The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of C-CAR011 in treatment of adult subjects with relapsed/refractory CD19+ B cells acute lymphoblastic leukemia(r/r CD19+B-ALL)

Detailed Description: This is a single-center, Open Label phase I clinical trial, 20 subjects planned to be enrolled. The trial have two stages (Phase I dose-escalation clinical trial and phase I dose expansion trial).Subjects will be divided into low-dose group, medium-dose group and high-dose group.Additional patients will be enrolled to confirm the optimal dose Dose CAR+ cells/kg Low 0.5×106 Medium 1.5×106 High 3.0×106