Who is eligible for clinical trial NCT06704269?

Participants must meet the protocol's inclusion criteria for Generalized Myasthenia Gravis. The stated age range is 18 Years to 65 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06704269 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-06-25

Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB323 in Generalized Myasthenia Gravis (NCT06704269)

An Open-label, Multi-center, Phase I/II Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB323 in Participants With Treatment-resistant Generalized Myasthenia Gravis

🟢 Recruiting Phase1 / Phase2 📋 Clinical Research Protocol Sponsor: Novartis Pharmaceuticals

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (7 items).

Location: Univ Cali Irvine ALS Neuromuscular — Orange, California

Age range: 18 Years to 65 Years

🧪 Interventions in This Study

YTB323 (GENETIC)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Confirmed gMG diagnosis supported by the following:
Documented report of positive serology testing for either AChR antibodies or MuSK antibodies at screening AND at least one of the following:
History of abnormal neuromuscular transmission test demonstrated by repetitive nerve stimulation or single-fiber electromyography
History of positive acetylcholinesterase inhibitor test
Improvement in MG signs on an oral acetylcholinesterase inhibitor as assessed by the treating physician
MGFA Class III-IVa (gMG) at screening
Treatment-resistant gMG as defined by: MG-ADL score ≥ 6 (≥50% non-ocular) at screening despite adequate treatment trials with at least two different non-steroidal immunosuppressive drugs given at adequate doses and duration of therapy.
If on chronic corticosteroids, must be on a stable dose of corticosteroids for ≥1 month prior to screening and have the ability and willingness to taper to a maximum dose of 10 mg prednisolone daily or equivalent at least one week before leukapheresis
If treated with cholinesterase inhibitors, patients must be on a stable dose for at least two weeks prior to screening

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Exclusively ocular myasthenia gravis (MGFA I), mild symptoms (MGFA II), or severe bulbar disease or MG crisis, MGFA Class IVb or V at screening
History of bone marrow/hematopoietic stem cell or solid organ transplantation.
Clinically significant active, opportunistic, chronic or recurrent infection (including positive for hepatitis B or hepatitis C) confirmed by clinical evidence, imaging, or positive laboratory tests one month prior to leukapheresis
Other uncontrolled disease states, such as asthma, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids, at screening
Participants with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune deficiency), or tested positive for HIV antibody, at screening
Prior treatment with anti-CD19 therapy, adoptive T cell therapy or any prior gene therapy product (e.g. CAR-T cell therapy). Other protocol-defined inclusion/exclusion criteria may apply

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (11 Sites)

Univ Cali Irvine ALS Neuromuscular — Orange, California
Wake Forest Univ School of Medicine — Winston-Salem, North Carolina
Thomas Jefferson University — Philadelphia, Pennsylvania
Houston Methodist Hospital — Houston, Texas
Novartis Investigative Site — Bordeaux,
Novartis Investigative Site — Brest,
Novartis Investigative Site — Lille,
Novartis Investigative Site — Chiba, Chiba
Novartis Investigative Site — Kyoto,
Novartis Investigative Site — Sheffield, South Yorkshire
Novartis Investigative Site — London,

📞 Contact the Study Coordinator

Phone: (888) 669-6682

Email: novartis.email@novartis.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗