ClinicaliQ Trial Snapshot
- KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis — Recruiting • Phase II • Oncology • NCT06193889.
- What is being tested: Anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, a genetically modified T-cell immunotherapy designed to target and eliminate CD19-expressing B cells in patients with generalised myasthenia gravis (gMG).
- Patient eligibility overview: The trial enrolls patients with gMG who have inadequate disease control despite standard immunosuppressive treatments; specific inclusion/exclusion criteria typically require documented autoimmune MG with anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibodies.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
A Study of the Anti-CD 19 Chimeric Antigen Receptor T Cell Therapy for Patients with Myasthenia Gravis
Eligibility Snapshot
- Key Inclusion Criteria 1. Presence of autoantibodies to AChR or MuSK 2. Myasthenia Gravis Foundation of America (MGFA) Class II-IV 3. MG-Activities of Daily Living (MG-ADL) total score of ≥6 at screening and confirmed at baseline visit 4. QMG total score of ≥11 at screening an confirmed at baseline visit 5. Failed treatment with 2 or more immunosuppressive/immunomodulatory therapies, or failed at least 1 immunosuppressive therapy and required chronic plasmapheresis, or IVIG (or subcutaneous or intramuscular Ig) to control symptoms 6. On a stable dose of glucocorticoids and/or other immunotherapies for ≥1 month prior to screening. For patients treated with azathioprine, a stable dose for ≥2 months prior to screening is required 7. No change in dose of acetylcholinesterase inhibitors for ≥2 weeks prior to screening 8. No use of intravenous immune globulin (IVIG) or plasmapheresis (PLEX) within 4 weeks of screening or pre-dose baseline (unless this is part of their SOC treatment regimen) 9. No use of rituximab (or any other anti-CD20 or CD19 monoclonal antibody) within 12 weeks prior to screening 10. Able and willing to attend the necessary visits to the study site Key
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.