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Clinical Trial Summary

This study is a Phase II, single-arm, open-label, non-randomized, dose-escalation clinical trial to evaluate the efficacy and safety of ssCART-19 Cell Injection in the treatment of patients with CD19 positive Relapsed or Refractory acute lymphoblastic leukemia, including central nervous system infiltration.


Clinical Trial Description

This study is a Phase II, single-arm, open-label, non-randomized, dose-escalation clinical trial to evaluate the efficacy and safety of ssCART-19 Cell Injection in the treatment of patients with CD19 positive Relapsed or Refractory acute lymphoblastic leukemia, including central nervous system infiltration. The study consists of screening period (8 weeks), treatment period (4 weeks), and follow-up period. All subjects who have received ssCART-19 infusion will be followed for safety and efficacy up to 2 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06367114
Study type Interventional
Source Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Contact Xiaoyan Lou, Dr.
Phone 18721281671
Email xiaoyan.lou@unicar-therapy.com
Status Not yet recruiting
Phase Phase 2
Start date April 2024
Completion date December 2025

See also
  Status Clinical Trial Phase
Completed NCT04230473 - A Clinical Trial of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia Phase 1
Terminated NCT01887587 - Vincristine, Doxorubicin, And Dexamethasone + Ixazomib in Acute Lymphoblastic Leukemia (ALL), Lymphoblastic Lymphoma Or Mixed Phenotype Acute Leukemia Phase 1
Recruiting NCT03018093 - A Phase I Study Evaluating Safety and Efficacy of C-CAR011 Treatment in Adult Subjects With r/r CD19+B-ALL Phase 1
Recruiting NCT04684147 - Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia Phase 2
Recruiting NCT04825496 - Clinical Study of ssCART-19 Cells in Patients With CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia Phase 1