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New treatment option for Autoimmune Diseases
Official title Anti-CD19/BCMA CAR-NK Cells in Patients With B Cell Mediated Autoimmune Disease
ClinicalTrials.gov ID: NCT06792799
What this study is testing
What is anti-CD19/BCMA CAR NK cells (KN5601)?
anti-CD19/BCMA CAR NK cells (KN5601) is an investigational medicine, being studied as a potential treatment for autoimmune diseases.
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
- this is an investigator-initiated trial aimed at evaluating the efficacy and safety of anti-CD19/BCMA CAR-NK Cells in Patients With B cell mediated autoimmune disease.
- 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 3 and older
You may be able to join if
- Patients or their legal guardians must acknowledge the risks and procedures involved and subsequently provide informed consent to participate in the...
- Predicted survival time ≥ 12 weeks;
- ECOG: 0\~2;
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥55% ;
- Renal function: eGFR≥30ML/min/1.73m2； (For patients with an eGFR \< 30 mL/min/1.73 m² or those receiving renal replacement therapy, inclusion or...
You likely can't join if
- people with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine...
- Uncontrollable infection, or active infection that requires systemic treatment within 1 week prior to screening；
- people with grade III or IV heart failure (NYHA classification)
- Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including...
- Renal replacement therapy has been or is being performed within 3 months prior to transfusion;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than...
See the full eligibility criteria
Who can join
- Patients or their legal guardians must acknowledge the risks and procedures involved and subsequently provide informed consent to participate in the clinical trial.
- Predicted survival time ≥ 12 weeks;
- ECOG: 0\~2;
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥55% ;
- Renal function: eGFR≥30ML/min/1.73m2； (For patients with an eGFR \< 30 mL/min/1.73 m² or those receiving renal replacement therapy, inclusion or exclusion in the study is determined at the discretion of the...
- Liver function: Asparagus cochinchinensis transase (AST) and Alanine Aminotransferase (ALT)≤3.0 ULN, Total Bilirubin (TBIL) in serum ≤2.0×ULN;
- Lung function: No serious lung lesions, SpO2≥92%;
- Negative pregnancy test for female people of childbearing age, agree to take effective contraceptive measures the first year after CAR-NK infusion; SLE:
- Age:≥5 years old;
- Diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria；
- Still in moderate to severe disease activity despite ≥3M of high dose glucocorticoids(prednisone≥1mg/kg/d or other equivalent amount of other steriod ), hydroxychloroquine and at least 2 of the following...
- SLEDAI 2K score\>6 points;
- No history of Central nervous system (CNS) disease within 60 days prior to screening;
- No history of macrophage activation syndrome (MAS) within one month prior to screening. MDR-SRNS
- Age ≥3 years old, gender unlimited;
- Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes （KDIGO） Guidelines and have not achieved a complete response after 12 months of treatment with two standard doses of hormone...
- Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS); IgA nephropathy
- Age: ≥ 5 years old, male or female;
- IgA nephropathy pathologically confirmed by renal biopsy;
- Angiotensin-Converting Enzyme Inhibitors (ACE) or angiotensin receptor blocker (ARB) treated for at least 3 months and meet at least one of the following requirements:
- Combination or sequential treatment with steroids and at least one immunosuppressant or biologic for ≥ 3 months; and 24-hour urine protein quantification ≥500mg or UPCR≥0.5mg/mg;
- \>50% decline in eGFR within 3 months;
- Patients who are unable to tolerate conventional treatment and for whom the investigator determines the benefits outweigh the risks and who have obtained fully informed consent from the patient or guardian may be...
- Exclude people with other secondary causes; exclude patients with uncontrolled blood pressure.
What rules you out
- 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
- Uncontrollable infection, or active infection that requires systemic treatment within 1 week prior to screening；
- people with grade III or IV heart failure (NYHA classification)
- Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia...
- Renal replacement therapy has been or is being performed within 3 months prior to transfusion;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody...
- Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening;
- Patients had seizure, or other active central nervous system disease;
- Patients with malignant diseases such as tumors before screening, or with other serious life-threatening diseases;
- Secondary or congenital immunodeficiency.
- History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the...
- Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus-host disease (GVHD) of grade 2 or above was present within 2 weeks prior to...
- Received live vaccine within 4 weeks before screening;
- people who have received B cell-targeted drug therapy within 1 month before enrollment
- Tested positive in Blood pregnancy test；
- Patients who participated in other clinical study within 3 months prior to 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
- Hangzhou, Zhejiang, 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, 3 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, 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.