NK510 Cell Therapy for Refractory Systemic Lupus Erythematosus

An Open, Single-Center Exploratory Clinical Study of NK510 Cell Therapy for Refractory Systemic Lupus Erythematosus

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Refractory Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: NK510 : allogeneic genetic modified NK

• Study Type: Interventional
• Enrollment (Estimated): 9
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 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:

  1. 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;
  2. Renal function: serum creatinine ≤ 1.5 times ULN, or creatinine clearance rate ≥ 60 mL/min;
  3. 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.

Exclusion Criteria:

• 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:

  1. HBsAg positive, and peripheral blood HBV-DNA titer ≥ 1×10³ copies/mL or upper limit of normal;
  2. Anti-HCV positive.
• Those deemed unsuitable for participation in the study by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NK510 infusion; NK510	Drug: NK510 : allogeneic genetic modified NK; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects who achieved lupus low disease activity state (LLDAS)	Low lupus disease activity was defined as SLEDAI-2K ≤ 4 points; no major organ system activity, no active hemolytic anemia or gastrointestinal involvement, and no new disease activity manifestations compared with the previous disease assessment; PGA score ≤ 1 point, daily prednisone equivalent dose ≤ 7.5 mg/day, with the permission of using maintenance doses of antimalarials and immunosuppressants (including biological agents).	3 months, 6 months after the first administration of NK510
Number of participants who achieved clinical remission of SLE	Clinical remission of SLE was defined by DORIS SLE remission criteria.	3 months, 6 months after the first administration of NK510
Changes of autoantibody of SLE from baseline	Autoantibody include anti-dsDNA, anti-nuclear antibody, ANA, anti-Sm antibody, and complement C3, C4.	Day 14, 3 months, 6 months after the first administration of NK510
The change of SLEDAI-2000(Systemic lupus erythematosus disease activity index 2000) scores	The change of SLEDAI-2000 score (from 0 to 105 points) will be compared to baseline.	Day 28, 3 months, 6 months after the first administration of NK510

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: July 16, 2025
• First Submitted That Met QC Criteria: July 16, 2025
• First Posted (Actual): July 24, 2025

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 23, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: SLE
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: NK510-14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No