Actively Recruiting
Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB323 in Generalized Myasthenia Gravis
Led by Novartis Pharmaceuticals · Updated on 2026-04-06
15
Participants Needed
10
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase I/II study to assess safety, efficacy, and cellular kinetics of YTB323 in participants with treatment-resistant generalized myasthenia gravis. YTB323 is a Biological CAR-T cell therapy.
CONDITIONS
Official Title
Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB323 in Generalized Myasthenia Gravis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of generalized myasthenia gravis supported by positive antibody testing and abnormal neuromuscular transmission or response to acetylcholinesterase inhibitors
- MGFA Class III-IVa generalized myasthenia gravis at screening
- Treatment-resistant generalized myasthenia gravis with MG-ADL score of 6 or higher despite trials of at least two different non-steroidal immunosuppressive drugs
- If using corticosteroids, stable dose for at least 1 month before screening and ability to taper to 10 mg prednisolone daily or less at least one week before leukapheresis
- Stable dose of cholinesterase inhibitors for at least two weeks before screening
You will not qualify if you...
- Exclusively ocular myasthenia gravis, mild symptoms, severe bulbar disease, or MG crisis (MGFA Class I, II, IVb, or V) at screening
- History of bone marrow, stem cell, or solid organ transplantation
- Active, opportunistic, chronic, or recurrent infections including hepatitis B or C within one month before leukapheresis
- Uncontrolled diseases like asthma or inflammatory bowel disease treated with corticosteroids at screening
- Known immunodeficiency syndromes or positive HIV antibody at screening
- Previous treatment with anti-CD19 therapy, adoptive T cell therapy, or gene therapy including CAR-T cell therapy
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Univ Cali Irvine ALS Neuromuscular
Orange, California, United States, 92868
Actively Recruiting
2
Wake Forest Univ School of Medicine
Winston-Salem, North Carolina, United States, 27157-1052
Actively Recruiting
3
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
4
Novartis Investigative Site
Bordeaux, France, 33076
Actively Recruiting
5
Novartis Investigative Site
Brest, France, 29200
Actively Recruiting
6
Novartis Investigative Site
Lille, France, 59037
Actively Recruiting
7
Novartis Investigative Site
Chiba, Japan, 2608677
Actively Recruiting
8
Novartis Investigative Site
Kyoto, Japan, 606-8507
Actively Recruiting
9
Novartis Investigative Site
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Actively Recruiting
10
Novartis Investigative Site
London, United Kingdom, SE5 9RS
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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