Actively Recruiting
An Exploratory Clinical Study of Anti-CD19 CAR NK Cells in the Treatment of Systemic Lupus Erythematosus
Led by Changhai Hospital · Updated on 2025-04-29
36
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
Sponsors
C
Changhai Hospital
Lead Sponsor
R
Rui Therapeutics Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-cluster of differentiation antigen 19 (CD19) chimeric antigen receptor (CAR) natural killer (NK) cells (KN5501) in patients with moderate to severe refractory systemic lupus erythematosus (SLE). 36 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study was to evaluate the safety of allogeneic anti-CD19 CAR-NK cells (KN5501) for the treatment of patients with moderate to severe refractory active SLE. The secondary objective is to evaluate the efficacy of anti-CD19 CAR NK cells (KN5501) in patients with moderate to severe refractory SLE, including British Isles Lupus Assessment Group 2004 (BILAG-2004) index, Systemic Lupus Erythematosus Responder Index (SRI)-4 response rate, Lupus Low Disease Activity State (LLDAS) rate, and Definitions Of Remission In SLE (DORIS) remission rate.
CONDITIONS
Official Title
An Exploratory Clinical Study of Anti-CD19 CAR NK Cells in the Treatment of Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years, male or female, who voluntarily agree to participate and sign informed consent
- Previous diagnosis of systemic lupus erythematosus (SLE) based on 1997 American Rheumatology Association criteria
- Females of childbearing potential must use effective contraception during treatment and for 90 days after last dose; no egg donation during this time
- SLE Disease Activity Index (SLEDAI-2K) score of 8 or higher before screening
- At least one organ system with BILAG-2004 Class A score or at least two organ systems with BILAG-2004 Class B score before screening
- Presence of one or more: antinuclear antibody (ANA) ≥1:80 by immunofluorescence, elevated anti-dsDNA antibodies, or elevated anti-Smith antibodies
- Absolute neutrophil count ≥1.0×10^9/L and hemoglobin ≥60 g/L
- Left ventricular ejection fraction (LVEF) of 50% or greater
- Prior treatment with oral corticosteroids combined with immunosuppressive or biologic agent for at least 6 months before enrollment
You will not qualify if you...
- Known severe allergic reactions, hypersensitivity, or contraindication to cyclophosphamide, fludarabine, or obinutuzumab
- Active infection requiring intravenous antibiotic treatment or received IV antibiotics within one week before CAR NK cell infusion
- Acquired or congenital immunodeficiency diseases
- Grade III or IV heart failure (NYHA classification)
- History of epilepsy or other central nervous system diseases
- History of severe herpetic infections like encephalitis, ocular herpes, or widespread herpes
- History of primary malignant tumors except cured non-melanoma skin cancer or certain cured cancers like cervical, superficial bladder, or breast cancer
- Signs of herpes or varicella-zoster virus infection within 12 weeks before screening
- History of major medical conditions that prevent administration of CAR NK cells, except lupus
- Pregnant, lactating, or planning pregnancy within six months
- Active skin diseases that interfere with lupus assessment, including psoriasis, dermatomyositis, systemic sclerosis, or drug-induced lupus
- Participation in other clinical trials within 3 months
- Receipt of B cell-targeted therapy within 1 month before enrollment
- Clinically significant abnormal laboratory test results as judged by investigators
- Any condition increasing risk or interfering with study outcomes as judged by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Changhai Hospital
Shanghai, China
Actively Recruiting
Research Team
D
Dongbao Zhao, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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