drugset / Trial / NCT05930314

CNCT19 Cell Injection for Refractory Systemic Lupus Erythematosus

NCT05930314

Phase 0 Unknown 12 enrolled Peking Union Medical College Hospital
NaSingle-groupOpen-labelTreatment

Summary

Investigator-initiated, single-arm, open-label, single dose clinical study to evaluate the safety and preliminary efficacy of CNCT19 in treatment of patients with refractory systemic lupus erythematosus(SLE) presented with active lupus nephritis or active immune thrombocytopenia.

Timeline

Start
2023-06-19
Primary completion
2024-05-30
Completion
2025-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject CNCT19 Cell therapy 2.5e+07 cells
Subject CNCT19 Cell therapy 5e+07 cells
Background Cyclophosphamide Other / unclassified 500 mg/m2
Background Fludarabine Small molecule 25 mg/m2
Background Fludarabine Small molecule 30 mg/m2