Product Description
KYV-101 is another version of CAR-T experimental cell therapy that aims to eliminate B cells to reduce inflammation. B-cells are responsible for creating antibodies, including autoantibodies, and are thought to play a role in the development and progression of autoimmune diseases. (Sourced from: https://www.lupus.org/news/new-investigational-drug-for-lupus-nephritis-receives-phase-1-clearance-from-fda)
Mechanisms of Action: CAR-T, CD19
Novel Mechanism: No
Modality: Autologous CAR-T
Route of Administration: Intravenous
FDA Designation: Fast Track - Lupus Nephritis|NephritisFast Track - Multiple SclerosisFast Track - Myasthenia Gravis *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Company: Kyverna
Company Location: Western America
Company Founding Year: 2018
Additional Commercial Interests: David Porter
Clinical Description
Countries in Clinic: Australia, Austria, Belgium, Brazil, Germany, Italy, Saudi Arabia, United Kingdom, United States
Active Clinical Trial Count:
Recent & Upcoming Milestones
- Clinical Outcomes Expected - Kyverna announced they will present P2 Stiff-Person Syndrome results on 2026-10-21 for Mivocabtagene autoleucel
- Clinical Outcomes Expected - Kyverna announced they will present P1 Multiple Sclerosis, Progressive results on 2026-10-23 for Mivocabtagene autoleucel
- Clinical Outcomes Reported - Kyverna presented P2 Myasthenia Gravis results on 2026-09-24 for Mivocabtagene autoleucel
Highest Development Phases
Phase 3: Arthritis, Rheumatoid|Lupus Nephritis|Myasthenia Gravis|Scleroderma, General
Phase 2: ANCA Vasculitis|Multiple Sclerosis, Primary Progressive|Multiple Sclerosis, Secondary Progressive
Phase 1: Lupus Vasculitis|Multiple Sclerosis, Progressive|Myositis|Scleroderma, Diffuse|Systemic Vasculitis
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06193889 |
KYSA-6 | P3 |
Recruiting |
Myasthenia Gravis |
2027-09-01 |
4% |
2026-07-09 |
Primary Endpoints|Treatments |
NCT06451159 |
NCT06451159 | P1 |
Active, not recruiting |
Multiple Sclerosis, Progressive |
2026-02-01 |
12% |
2026-08-11 |
Primary Endpoints|Treatments |
NCT06590545 |
IDEAL | P2 |
Not yet recruiting |
ANCA Vasculitis |
2027-01-01 |
2024-09-20 |
Primary Endpoints|Treatments |
|
2024-511198-31-00 |
KYV101-004 | P3 |
Not yet recruiting |
Scleroderma, General|Arthritis, Rheumatoid|Myasthenia Gravis|Lupus Nephritis |
2042-12-31 |
|||
NCT06152172 |
CARTIMMUNE | P1 |
Active, not recruiting |
Systemic Vasculitis|Lupus Nephritis|ANCA Vasculitis|Scleroderma, Diffuse|Myositis|Lupus Vasculitis |
2027-02-01 |
12% |
2026-02-19 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT06475495 |
COMPARE | P2 |
Active, not recruiting |
Arthritis, Rheumatoid |
2027-06-01 |
12% |
2026-03-07 |
|
NCT06384976 |
KYSA-7 | P2 |
Active, not recruiting |
Multiple Sclerosis, Primary Progressive|Multiple Sclerosis, Secondary Progressive |
2027-04-01 |
2025-01-14 |
Primary Endpoints|Start Date|Treatments|Trial Status |
|
NCT06138132 |
NCT06138132 | P1 |
Recruiting |
Multiple Sclerosis, Primary Progressive|Multiple Sclerosis, Secondary Progressive |
2027-06-01 |
50% |
2026-02-28 |
Primary Endpoints|Treatments|Trial Status |
2023-509892-17-00 |
KYV101-006 | P2 |
Recruiting |
Myasthenia Gravis |
2027-12-31 |
2025-05-02 |
Treatments |
|
2024-511168-10-00 |
KYV101-007 | P2 |
Not yet recruiting |
Multiple Sclerosis, Primary Progressive|Multiple Sclerosis, Secondary Progressive |
2028-07-11 |
2025-05-02 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
04/09/2026 |
News Article |
Kyverna Therapeutics to Host Conference Call on New Data Across Neuroimmunology Franchise at AAN 2026 |
|
03/05/2026 |
News Article |
Kyverna Therapeutics to Present New Data from Neuroimmunology Franchise at AAN 2026 |
|
03/03/2026 |
News Article |
Kyverna Therapeutics to Participate in Upcoming March Investor Conferences |
|
01/12/2026 |
News Article |
Kyverna Therapeutics Provides Corporate Update and Outlines 2026 Strategic Priorities at the J.P. Morgan Healthcare Conference |