NK010 or NK042 in Combination With Rituximab for Refractory Systemic Lupus Erythematosus/Lupus Nephritis

PHASE1RecruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

February 19, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Refractory Systemic Lupus ErythematosusRefractory Lupus Nephritis
Interventions
BIOLOGICAL

NK 010 or NK042

NK010 is an allogeneic non-genetically modified NK cell infusion. NKX010 will be administered at a dose of 2.5 × 109 NK cells, 5.0 × 109 NK cells and 7.5 × 109 NK cells by a dose-escalation design and administered IV. N042 is an allogeneic genetic modification of NK cell. NKX042 will be administered at a dose of 6 × 108 NKR positive NK cells, 1.2 × 109 NKR positive NK cells and 2.4 × 109 NKR positive NK cells by a dose-escalation design and administered IV.

DRUG

Rituximab

RTX dose of 1 g administered IV over 60 minutes at the first day of the treatment phase.

Trial Locations (1)

510080

RECRUITING

Guangdong Provincial People's Hospital, Guangzhou

All Listed Sponsors
lead

Guangdong Provincial People's Hospital

OTHER