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New treatment option for Antisynthetase Syndrome
Official title An Exploratory Clinical Study of CD19 CAR NK Cells for the Treatment of Refractory Antisynthetase Antibody Syndrome and Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT06613490
What this study is testing
What is anti CD19 CAR NK cells?
anti CD19 CAR NK cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for antisynthetase syndrome.
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-center, open-label dose-escalation design to evaluate the safety and efficacy of 3 infusions of anti CD19 CAR NK cells (KN5501), as well as the expansion and persistence of KN5501 in patients with refractory antisynthetase antibody syndrome (ASyS) and rheumatoid arthritis (RA); To evaluate the ability of KN5501 to clear CD19-positive B cells in patients to determine the feasibility of KN5501 for the treatment of refractory ASyS and or RA.
- 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 70
You may be able to join if
- people voluntarily sign the Informed Consent Form (ICF) , participate in this clinical study and be willing to follow and be able to complete all...
- Defined according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria, adult...
- Defined according to the 2020 ENMC-DM classification diagnostic criteria. Adult patients with ASyS diagnosed ≥3 months prior to screening; patients...
- Age: ≥ 18 years old and ≤ 70 years old, male or female.
- people with estimated survival \> 12 weeks.
You likely can't join if
- people with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine...
- people with one of the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any of the known bone marrow failure...
- people with Active or uncontrolled infections requiring parenteral antimicrobials; evidence of severe active viral or bacterial infections or...
- people with grade III or IV heart failure (NYHA classification).
- History of epilepsy or other central nervous system (CNS) diseases.
- people with history of malignancy except cured of carcinoma in situ of the skin or cervix, and patients with inactive tumors.
See the full eligibility criteria
- people voluntarily sign the Informed Consent Form (ICF) , participate in this clinical study and be willing to follow and be able to complete all trial procedures.
- Defined according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria, adult patients with RA diagnosed ≥3 months prior to screening;Moderately to...
- Defined according to the 2020 ENMC-DM classification diagnostic criteria. Adult patients with ASyS diagnosed ≥3 months prior to screening; patients with moderately severe active ASyS.
- Age: ≥ 18 years old and ≤ 70 years old, male or female.
- people with estimated survival \> 12 weeks.
- Serum creatinine clearance meets the relevant age/sex criteria, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN).
- ECOG score 0 - 2.
- The heart structure is essentially normal by echocardiography and Left ventricular ejection fraction (LVEF) ≥45%.
- 2 weeks after the subject received the last dose treatment (hormonal, immunosuppressive or other experimental treatment).
- people with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or people with a history of severe allergic reactions.
- people with one of the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any of the known bone marrow failure syndromes.
- people with Active or uncontrolled infections requiring parenteral antimicrobials; evidence of severe active viral or bacterial infections or uncontrolled systemic fungal infections.
- people with grade III or IV heart failure (NYHA classification).
- History of epilepsy or other central nervous system (CNS) diseases.
- people with history of malignancy except cured of carcinoma in situ of the skin or cervix, and patients with inactive tumors.
- people with pronounced bleeding tendencies, such as gastrointestinal bleeding, coagulation disorders, and hypersplenism.
- The subject with unstable angina, symptomatic congestive heart failure or myocardial infarction within the last 6 months.
- Females who are pregnant, lactating, or planning a pregnancy within six months.
- people who have received other clinical trial treatment within 3 months.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, 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.