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New treatment option for Autoimmune Diseases
Official title A Clinical Study of CD19 CAR NK Cells for the Treatment of Relapsed/Refractory B-cell Related Autoimmune Diseases
ClinicalTrials.gov ID: NCT06318533
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 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
- A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cells (KN5501) in patients with relapsed/refractory B-cell related autoimmune diseases.15 patients are planned to be enrolled in the dose-escalation trial (6×10\^9 cells, 9×10\^9 cells). The primary objective of the study is to evaluation of the safety and feasibility of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases.
- 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 participate in this clinical study and sign the Informed Consent Form (ICF) and are willing to follow and be able to complete all...
- people disease status of enrolment: not complete response (CR) after standard treatment; moderately to severely active autoimmune diseases
- Age: ≥ 18 years old and ≤ 70 years old, male or female
- people with estimated survival \> 12 weeks
- Adequate organs function: Serum creatinine clearance meets relevant age/sex criteria,aspartate aminotransferase (AST) and alanine aminotransferase...
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
- History of other primary malignant tumors except: cured non-melanoma skin cancer or primary cervical cancer; people with inactive tumors
See the full eligibility criteria
- people voluntarily participate in this clinical study and sign the Informed Consent Form (ICF) and are willing to follow and be able to complete all trial procedures
- people disease status of enrolment: not complete response (CR) after standard treatment; moderately to severely active autoimmune diseases
- Age: ≥ 18 years old and ≤ 70 years old, male or female
- people with estimated survival \> 12 weeks
- Adequate organs function: Serum creatinine clearance meets relevant age/sex criteria,aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN)
- ECOG performance ≤ 2
- Left ventricular ejection fraction (LVEF) ≥ 45%
- people have been treated with OCS in combination with an immunosuppressive or biologic agent for at least 2 weeks prior to enrollment
- 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
- History of other primary malignant tumors except: cured non-melanoma skin cancer or primary cervical cancer; people with inactive tumors
- people with more pronounced bleeding tendencies, such as gastrointestinal bleeding, coagulation disorders, and hypersplenism
- people were treated with systemic corticosteroids concomitantly within 2 weeks prior to treatment
- people 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
- 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
- Zhenjiang, 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 Zhenjiang, 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.