NK510 Cell Therapy for Refractory Systemic Lupus Erythematosus

NCT07083349 | Not Yet Recruiting

• 1 other identifier: NK510-14
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an investigator-initiated, open-label, single-arm study to determine safety and preliminary efficacy of NK510 for the treatment of patients with refractory systemic lupus erythematosus (SLE) in China.

Conditions

Refractory Systemic Lupus Erythematosus

Keywords

SLE

Outcome Measures

Primary Outcomes (3)

• Response rate for SLE response index 4 (SRI4)

  SRI4 response defined as a reduction of ≥4 points on SLEDAI-2000, no new domain A scores and no more than 1 new domain B score on BILAG 2004, and no deterioration in PGA (\<0.3 point increase).

  3 months, 6 months after the first administration of NK510

• Incidence of treatment-related adverse events

  This is to measure safety and tolerability of NK510

  1 year

• Dose-limiting toxicity (DLT) rate

  This is to measure the dose-limiting toxicity of NK510

  28 days after initial study treatment.

Secondary Outcomes (4)

• Number of subjects who achieved lupus low disease activity state (LLDAS)

  3 months, 6 months after the first administration of NK510

• Number of participants who achieved clinical remission of SLE

  3 months, 6 months after the first administration of NK510

• The change of SLEDAI-2000(Systemic lupus erythematosus disease activity index 2000) scores

  Day 28, 3 months, 6 months after the first administration of NK510

• Changes of autoantibody of SLE from baseline

  Day 14, 3 months, 6 months after the first administration of NK510

Study Arms (1)

NK510 infusion

EXPERIMENTAL

NK510

Drug: NK510 : allogeneic genetic modified NK

Interventions

NK510 : allogeneic genetic modified NK DRUG

NK510 is an allogeneic genetic modification of NK cell. NK510 will be administered at a dose of 4x10\^7 NK/kg, 8x10\^7 NK/kg and 1.2x10\^8 NK/kg by a dose-escalation design and administered IV.

NK510 infusion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 70 years old, male or female.
• A diagnosis of SLE according to the 2019 EULAR (European League Against Rheumatism)/ACR (American College of Rheumatology).
• The subject voluntarily participates in this clinical study and signs the Informed Consent Form (ICF).
• Before screening, the subject must have received glucocorticoid combined with immunosuppressants and/or biological agents for at least 2 months, with a stable dose for more than 2 weeks, but the disease remains active; within 7 days before lymphodepleting conditioning, the blood routine test must meet the following requirements: absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; hemoglobin (Hb) ≥ 80g/L; platelet count (PLT) ≥ 50×10⁹/L.
• SLEDAI-2K score \> 8 points at screening.
• Antinuclear antibody (ANA) ≥ 1:80 at screening.
• Having appropriate organ functions:
• Liver function: aspartate transaminase (AST) ≤ 3 times the upper limit of normal (ULN); alanine transaminase (ALT) ≤ 3 times ULN; total bilirubin ≤ 1.5 times ULN, unless the subject has a record of Gilbert syndrome; subjects with Gilbert-Meulengracht syndrome with total bilirubin ≤ 3.0 times ULN and direct bilirubin ≤ 1.5 times ULN can be included;
• Renal function: serum creatinine ≤ 1.5 times ULN, or creatinine clearance rate ≥ 60 mL/min;
• Blood routine: absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; absolute lymphocyte count (ALC) ≥ 0.1×10⁹/L; hemoglobin (Hb) ≥ 80 g/L; platelet count (PLT) ≥ 50×10⁹/L.
• Women of childbearing age must be non-lactating and have a negative serum pregnancy test within 1 week before administration. In addition, all subjects (whether male or female) must agree to use contraception during the period of NK510 treatment starting from enrollment and within 3 months after the end of treatment.
• Able to comply with the study protocol and follow-up procedures.

You may not qualify if:

• Patients with active lupus nephritis.
• Those with allergies to the study drug or other medications used in the study protocol.
• Those with any of the following conditions: ① Having received autologous/allogeneic hematopoietic stem cell transplantation within 3 months; ② Having received ultraviolet irradiation therapy within 6 weeks; ③ Having received biologic agent therapy (excluding other medications used in the study protocol) within 4 weeks or 3 half-lives (whichever is longer); ④ Having undergone major surgery or received live vaccines within 4 weeks; ⑤ Having received experimental treatment (except for definite placebo control groups) within 4 weeks.
• Those with other active, known, or suspected autoimmune diseases.
• Presence of uncontrolled active bacterial, viral, fungal, mycobacterial, or other infections requiring treatment with intravenous antibiotics, antiviral drugs, or antifungal drugs within 14 days before lymphodepleting conditioning; however, prophylactic use of these drugs (including intravenous administration) is allowed.
• History of immunodeficiency, including positive HIV test results, or other acquired/congenital immunodeficiency diseases, or history of organ transplantation.
• History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac rhythm or conduction abnormalities (e.g., ventricular arrhythmias requiring clinical intervention, third-degree atrioventricular block, etc.); QTc interval \> 480 ms on 12-lead electrocardiogram at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events within 6 months before administration; New York Heart Association (NYHA) cardiac function class ≥ II or left ventricular ejection fraction (LVEF) \< 50%.
• Failure to fully recover from major surgery or trauma within 2 weeks before administration.
• History of malignant tumors.
• Screening results of hepatitis B or C virological tests meeting any of the following:
• HBsAg positive, and peripheral blood HBV-DNA titer ≥ 1×10³ copies/mL or upper limit of normal;
• Anti-HCV positive.
• Those deemed unsuitable for participation in the study by the investigator.

Sponsors & Collaborators

• Base Therapeutics (Shanghai) Co., Ltd.: lead
• The First Affiliated Hospital of Anhui Medical University: collaborator

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: NK510 is an allogeneic genetically modified NK cell infusion.

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07