NK510 Cell Therapy for Refractory 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
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
Treatments tested in this trial
- NK510 : allogeneic genetic modified NK
Treatment groups
9 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Base Therapeutics (Shanghai) Co., Ltd.
Lead sponsor
The First Affiliated Hospital of Anhui Medical University
Collaborator
Source ClinicalTrials.gov