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New treatment option for Systemic Lupus Erythematosus (SLE)
Official title An Exploratory Clinical Study of Anti-CD19 CAR NK Cells in the Treatment of Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT06010472
What this study is testing
What is anti-CD19 CAR NK cells (KN5501)?
anti-CD19 CAR NK cells (KN5501) is an investigational medicine, being studied as a potential treatment for systemic lupus erythematosus (sle).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age: ≥ 18 years old and ≤ 65 years old, male or female, people 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...
- people 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
You likely can't join if
- people with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine...
- people with active infection receiving intravenous (IV) antibiotic treatment, or received intravenous (IV) antibiotic treatment within one week prior...
- people with acquired and congenital immunodeficiency diseases
- people with grade III or IV heart failure (NYHA classification)
- History of epilepsy or other central nervous system (CNS) diseases
- History of severe herpetic infection, such as herpetic encephalitis, ocular herpes, or diffuse herpes
See the full eligibility criteria
- Age: ≥ 18 years old and ≤ 65 years old, male or female, people 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, people must not donate eggs during the study and for at...
- people 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
- people 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%
- people have been treated with oral corticosteroids (OCS) in combination with an immunosuppressive or biologic agent for at least 6 months prior to enrollment
- people with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, obinutuzumab), or people with a history of severe allergic reactions
- people with active infection receiving intravenous (IV) antibiotic treatment, or received intravenous (IV) antibiotic treatment within one week prior to anti-CD19 CAR NK Cells infusion
- people with acquired and congenital immunodeficiency diseases
- people with grade III or IV heart failure (NYHA classification)
- History of epilepsy or other central nervous system (CNS) diseases
- History of severe herpetic infection, such as herpetic encephalitis, ocular herpes, or diffuse herpes
- History of other primary malignant tumors except:
- Cured non-melanoma skin cancer by surgical excision, for example basal cell carcinoma (BCC) ;
- Cured primary malignant tumors, such as cervical cancer, superficial bladder cancer, breast cancer
- Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening; History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic...
- Females who are pregnant, lactating, or planning a pregnancy within six months
- Any active skin disease that may interfere with the study assessment of SLE, including but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-LE cutaneous lupus manifestations (eg, cutaneous vascular...
- people who have received other clinical trial treatment within 3 months
- people who have received B cell-targeted drug therapy within 1 month before enrollment
- Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical...
- Any situation judged by the investigators that may increase the risk of the people or interfere with the clinical trial outcome
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.