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

Sponsor
Guangdong Provincial People's Hospital
Study ID
NCT06676631
Phase
PHASE1
Status
Recruiting
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Conditions

  • Refractory Lupus Nephritis
  • Refractory Systemic Lupus Erythematosus

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • NK 010 or NK042 — BIOLOGICAL
    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.
  • Rituximab — DRUG
    RTX dose of 1 g administered IV over 60 minutes at the first day of the treatment phase.

Study Details

This is an investigator-initiated, open-label, single-arm study to determine safety and preliminary efficacy of NK010 or NK042 in combination with rituximab (RTX) for the treatment of patients with refractory systemic lupus erythematosus (SLE) or lupus nephritis (LN) in China.

Key Dates

Start date
Feb 19, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NK 010 or NK 042 infusion
    Subjects with refractory SLE or LN will receive rituximab followed by NK010 or NK042.

Primary Outcome Measure

Response rate for SLE response index 4 (SRI4) [ Time Frame: Day 14, day 28, 2 months, 3 months, 6 months, 9 months, 12 months after the first administration of NK010 or NK042 infusion ]

Central Contacts

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