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NK510 Cell Therapy for Refractory Systemic Lupus Erythematosus

ConditionRefractory Systemic Lupus Erythematosus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBase Therapeutics (Shanghai) Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

9 Participants
are divided into 1 treatment group
Group A: NK510 infusionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
3 months, 6 months after the first administration of NK510
2

Incidence of treatment-related adverse events

This is to measure safety and tolerability of NK510

Time frame
1 year
3

Dose-limiting toxicity (DLT) rate

This is to measure the dose-limiting toxicity of NK510

Time frame
28 days after initial study treatment.

Secondary outcomes

1

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).

Time frame
3 months, 6 months after the first administration of NK510
2

Number of participants who achieved clinical remission of SLE

Clinical remission of SLE was defined by DORIS SLE remission criteria.

Time frame
3 months, 6 months after the first administration of NK510
3

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.

Time frame
Day 28, 3 months, 6 months after the first administration of NK510
4

Changes of autoantibody of SLE from baseline

Autoantibody include anti-dsDNA, anti-nuclear antibody, ANA, anti-Sm antibody, and complement C3, C4.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Base Therapeutics (Shanghai) Co., Ltd.

Lead sponsor

The First Affiliated Hospital of Anhui Medical University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: