Using CAR NK cells to treat autoimmune diseases
An Exploratory Clinical Study of the Safety and Efficacy of CD19 Chimeric Antigen Receptor NK Cell Injections for the Treatment of Relapsed/Refractory B-cell Related Autoimmune Diseases
EARLY_PHASE1 · Affiliated Hospital of Jiangsu University · NCT06318533
This study is testing a new treatment using special immune cells to see if it can help people with tough autoimmune diseases related to B-cells feel better.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Affiliated Hospital of Jiangsu University (other) |
| Drugs / interventions | cyclophosphamide, fludarabine |
| Locations | 2 sites (Zhenjiang, Jiangsu and 1 other locations) |
| Trial ID | NCT06318533 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the safety and effectiveness of anti-CD19 CAR NK cells (KN5501) in patients suffering from relapsed or refractory B-cell related autoimmune diseases. It is a single-arm, open-label trial that plans to enroll 15 patients in a dose-escalation format, administering two different doses of the treatment. The primary goal is to assess the safety and feasibility of KN5501, while secondary objectives focus on its effectiveness and the ability to deplete CD19 positive B cells. The study also aims to explore the expansion and persistence of the CAR NK cells in the patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with moderately to severely active B-cell related autoimmune diseases that have not responded to standard treatments.
Not a fit: Patients with complete response to previous treatments or those with severe allergic reactions to trial medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients with difficult-to-treat autoimmune diseases.
How similar studies have performed: While CAR T-cell therapies have shown success in hematological malignancies, the application of CAR NK cells in autoimmune diseases is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects 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 2. Subjects disease status of enrolment: not complete response (CR) after standard treatment; moderately to severely active autoimmune diseases 3. Age: ≥ 18 years old and ≤ 70 years old, male or female 4. Subjects with estimated survival \> 12 weeks 5. 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) 6. ECOG performance ≤ 2 7. Left ventricular ejection fraction (LVEF) ≥ 45% 8. Subjects have been treated with OCS in combination with an immunosuppressive or biologic agent for at least 2 weeks prior to enrollment Exclusion Criteria: 1. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions 2. Subjects with one of the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any of the known bone marrow failure syndromes 3. Subjects with active or uncontrolled infections requiring parenteral antimicrobials; evidence of severe active viral or bacterial infections or uncontrolled systemic fungal infections 4. Subjects with grade III or IV heart failure (NYHA classification) 5. History of epilepsy or other central nervous system (CNS) diseases 6. History of other primary malignant tumors except: cured non-melanoma skin cancer or primary cervical cancer; subjects with inactive tumors 7. Subjects with more pronounced bleeding tendencies, such as gastrointestinal bleeding, coagulation disorders, and hypersplenism 8. Subjects were treated with systemic corticosteroids concomitantly within 2 weeks prior to treatment 9. Subjects with unstable angina, symptomatic congestive heart failure or myocardial infarction within the last 6 months 10. Females who are pregnant, lactating, or planning a pregnancy within six months 11. Subjects who have received other clinical trial treatment within 3 months 12. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome
Where this trial is running
Zhenjiang, Jiangsu and 1 other locations
- Affiliated Hospital of Jiangsu University — Zhenjiang, Jiangsu, China (RECRUITING)
- Jiangsu University Affiliated Hospital — Zhenjiang, Jiangsu, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Autoimmune Diseases