CD19 CART Therapy vs SOC Study in Myasthenia Gravis Patients (KYSA-6)

• Research type

  Research Study

• Full title

  A Phase 2/3, Open-Label, Randomized, Controlled, Multicenter Study of KYV-101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, Versus Ongoing Standard-Of-Care Immunosuppressive Therapy in Patients with Generalized Myasthenia Gravis (KYSA-6)

• IRAS ID

  1013097

• Contact name

  Medical Kyverna N/A

• Contact email

  ClinicalTrials@kyvernatx.com

• Sponsor organisation

  Kyverna Therapeutics, Inc.

• Clinicaltrials.gov Identifier

  NCT06193889

• Research summary

  Kyverna Therapeutics, Inc. is sponsoring this study to test an experimental treatment called KYV-101 for treatment of Myasthenia Gravis. KYV-101 is a chimeric antigen receptor (CAR) T cell therapy. It is a type of therapy made from the recipient’s immune cells that will work to eliminate the cells that can cause disease inflammation. This study is designed to evaluate the safety, tolerability and effectiveness of treatment with KYV-101. This will be done by comparing the results from participants treated with KYV-101 against those continuing to receive their current therapy for MG. This study will have approximately 66 participants with MG from research sites, globally.
  All participants will undergo a procedure called apheresis to collect some white blood cells in order to make KYV-101 cells for treatment. Afterwards, participants will restart their prior therapy for about 2 months.
  Participants still meeting the study requirements will then randomly be assigned to one of the treatment groups:
  • SOC: will continue to receive their current medications until week 24 and will then be assessed to see if they are eligible to receive KYV-101 treatment.
  • KYV-101: will undergo a washout/lowering of current medications followed by lymphodepletion (to temporarily weaken immune cells so they don’t prevent study treatment working). Treatment with KYV-101, intravenously, will then begin. After the KYV-101 infusion, participants will enter the post-infusion phase which lasts until the end of the study (18 months after randomisation).
  Participants will undergo tests/procedures including blood and urine tests, questionnaires and testing of the lungs. After treatment, participants will attend regular follow-up visits. There will also be a separate long-term 15-year follow-up period, to assess the risk of delayed side effects and to monitor KYV101’s long-term effectiveness. Study duration is dependent on the overall duration and how long participants are willing to participate

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  25/LO/0848

• Date of REC Opinion

  20 Jan 2026

• REC opinion

  Further Information Favourable Opinion