An Exploratory Clinical Study of the Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor (CAR) Nature Killer Cells (KN5501) in the Treatment of Moderate to Severe Refractory Systemic Lupus Erythematosus (SLE)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• Age: ≥ 18 years old and ≤ 65 years old, male or female, subjects voluntarily participate in this clinical study and sign the Informed Consent Form (ICF)

• Previous diagnosis of systemic lupus erythematosus (SLE) (according to the 1997 American Rheumatology Association criteria)

• Females of childbearing potential must use effective contraception during study treatment and for 90 days after the last dose of study treatment. In addition, subjects must not donate eggs during the study and for at least 90 days after the last dose of study treatment

• Subjects with Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score ≥ 8 points prior to screening

• Subject has ≥ 1 organ system with BILAG-2004 Class A mobility score or ≥ 2 organ systems with BILAG-2004 Class B mobility score prior to screening

• Subjects meets one of the following:

‣ Antinuclear antibody (ANA) ≥ 1:80, determined by immunofluorescence method;

⁃ Anti-dsDNA antibodies are higher than normal level;

⁃ Anti-Smith antibodies are higher than normal level

• Absolute number of neutrophils ≥ 1.0×10\^9/L, hemoglobin ≥ 60g/L

• Left ventricular ejection fraction (LVEF) ≥ 50%

• Subjects have been treated with oral corticosteroids (OCS) in combination with an immunosuppressive or biologic agent for at least 6 months prior to enrollment

Locations
Other Locations
China
Changhai Hospital
RECRUITING
Shanghai
Contact Information
Primary
Dongbao Zhao, Doctor
dongbaozhao@163.com
+86-15921061314
Time Frame
Start Date: 2023-08-20
Estimated Completion Date: 2027-08-25
Participants
Target number of participants: 36
Treatments
Experimental: anti-CD19 CAR NK cells
To evaluate the safety and effectiveness of anti-CD19 CAR NK cells (KN5501) in patients with moderate to severe refractory SLE. All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by anti-CD19 CAR NK cells infusion.
Related Therapeutic Areas
Sponsors
Leads: Changhai Hospital
Collaborators: Rui Therapeutics Co., Ltd

This content was sourced from clinicaltrials.gov