NCT05930314

CNCT19 Cell Injection for Refractory Systemic Lupus Erythematosus

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Refractory Systemic Lupus Erythematosus
• Lupus Nephritis
• Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	CNCT19 cell injection	Leukapheresis and manufacturing of CNCT19: enrolled subjects will undergo a leukapheresis to target a yield of \> 1x 10\^9 mononuclear cells * Lymphodepleting chemotherapy i. Fludarabine 25 to 30 mg/m2, once daily for 3 days ii. Cyclophosphamide 500 mg/m2, once daily for 3 days * CNCT19 administration i. 0.25 to 0.5 x 10\^8 CAR-positive viable T cells

Timeline

• Start date: 2023-06-19
• Primary completion: 2024-05-30
• Completion: 2025-05-30
• First posted: 2023-07-05
• Last updated: 2023-07-05

Locations

1 site across 1 country: China