YTB323 for Myasthenia Gravis

Recruiting at 5 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Novartis Pharmaceuticals

Must be taking: Cholinesterase inhibitors

Must not be taking: Anti-CD19 therapy

Disqualifiers: Ocular MG, Transplant history, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that if you are on chronic corticosteroids, you must be willing to reduce your dose to a maximum of 10 mg of prednisolone daily at least one week before a procedure called leukapheresis. If you are taking cholinesterase inhibitors, you need to be on a stable dose for at least two weeks before screening.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for people with generalized myasthenia gravis (gMG) who haven't improved after trying at least two different non-steroidal immunosuppressive drugs. They should have a certain level of muscle weakness, a history of abnormal neuromuscular tests, and be able to reduce their use of steroids or maintain a stable dose of cholinesterase inhibitors.

Inclusion Criteria

My myasthenia gravis is severe and hasn't improved with at least two different treatments.

I can reduce my steroid use to 10 mg of prednisolone daily before a specific procedure.

I've been on a steady dose of memory medications for over two weeks.

Exclusion Criteria

My myasthenia gravis ranges from eye-related symptoms to severe with crisis.

Known immunodeficiency syndrome, tested positive for HIV antibody, or prior treatment with specific therapies

I have had a bone marrow, stem cell, or organ transplant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intravenous infusion of YTB323

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Regular visits (frequency not specified)

Long-Term Follow-up

Participants are followed until 15 years after YTB323 administration

15 years

Treatment Details

Interventions

• YTB323

Trial Overview The study is testing YTB323, which is a CAR-T cell therapy—a type of treatment that modifies the patient's immune cells to fight the disease. It aims to see if this new therapy is safe, effective, and how it affects the body's cells in those with treatment-resistant gMG.

Participant Groups

Group I: YTB323 Experimental Treatment 1 Intervention

YTB323 single intravenous (i.v.) infusion

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD