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ACTIVE NOT RECRUITINGPhase1/Phase2

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

Sponsor: Novartis Pharmaceuticals

NCT ID: NCT06704269

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
YTB323 (genetic)
How long the study runs
Study runs about 54 months (dates as stated)
About the drug or intervention
YTB323 — genetic: CAR-T cell suspension for intravenous infusion
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by Novartis Pharmaceuticals, is looking at an experimental treatment called YTB323 for people with generalised myasthenia gravis (a condition where the immune system affects the muscles). The researchers want to find out about its safety, how well it works, and how it behaves in the body. Not stated — ask the trial team for more details on what YTB323 is.

Who can take part

  • A confirmed diagnosis of generalised myasthenia gravis, with positive blood tests for either AChR (acetylcholine receptor) antibodies or MuSK antibodies, plus other supporting test results
  • Moderate to significant muscle weakness (MGFA Class III–IVa) at screening
  • Symptoms that have not improved enough despite trying at least two different immunosuppressive medicines (not steroids) at adequate doses and for enough time
  • An MG-ADL (Myasthenia Gravis Activities of Daily Living) score of 6 or higher, with at least half the symptoms not related to the eyes
  • If taking steroid tablets, the dose must have been stable for at least 1 month, and the person must be willing and able to reduce to a maximum of 10 mg prednisolone (or equivalent) daily at least one week before a procedure called leukapheresis (collecting white blood cells)
  • If taking cholinesterase inhibitor medicines, the dose must have been stable for at least 2 weeks before screening

Who may not be able to

  • Myasthenia gravis that only affects the eyes, mild symptoms, or very severe swallowing/breathing problems or myasthenia crisis (MGFA Class I, II, IVb or V)
  • Past bone marrow, blood stem cell, or solid organ transplant
  • Significant active, long-term, or repeated infections (including hepatitis B or hepatitis C) in the month before leukapheresis
  • Other uncontrolled conditions, such as asthma or inflammatory bowel disease, that are often treated with steroid medicines
  • Known immunodeficiency (for example AIDS, an inherited immune problem, or medicine-related immune problems) or a positive HIV test
  • Previous treatment with anti-CD19 therapy, adoptive T cell therapy, or any gene therapy (for example CAR-T cell therapy)

What taking part involves

  • • YTB323 (the treatment being studied) — how it is given is not stated — ask the trial team
  • • A procedure called leukapheresis, which collects white blood cells from the blood
  • • Blood tests and other checks during screening to confirm eligibility

Time commitment: Not stated — ask the trial team about how many visits there are, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 65 Years
Who
All
Number of participants
15
Started
2025-04-22
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for generalized myasthenia gravis
  • • Phase1/Phase2 - 15 participants
  • • This is a phase I/II study to assess safety, efficacy, and cellular kinetics of YTB323 in participants with treatment-resistant generalized myasthenia gravis

Who can take part?

  • • Ages 18 Years to 65 Years
  • • Diagnosed with generalized myasthenia gravis

Where?

  • • Sheffield - Novartis Investigative Site
  • • London - Novartis Investigative Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About 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.

More detail

This is an open-label, multi-center, non-confirmatory study intended to assess safety, efficacy, and cellular kinetics of YTB323 treatment in participants with treatment-resistant generalized myasthenia gravis in order to enable a benefit to risk assessment for further development in generalized myasthenia gravis (gMG). The study plans to enroll approximately 15 participants with treatment-resistant gMG. The study utilizes a single dose design across 2 cohorts, consisting of a sentinel cohort of 3 patients followed by an expansion cohort of an additional 12 patients. All participants dosed with YTB323 will be followed until 15 years after YTB323 administration in the Long-Term Follow-up (LTFU).

Generalized Myasthenia Gravis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 65 Years
  • Who can join: All genders

Biomarkers mentioned

report of positiveHistory of positiveincluding positiveor positivetested positiveCD19

What the study is looking for

  • ✓Confirmed gMG diagnosis supported by the following:
  • ✓Documented report of positive serology testing for either AChR antibodies or MuSK antibodies at screening AND at...
  • ✓History of abnormal neuromuscular transmission test demonstrated by repetitive nerve stimulation or single-fiber...
  • ✓History of positive acetylcholinesterase inhibitor test
  • ✓Improvement in MG signs on an oral acetylcholinesterase inhibitor as assessed by the treating physician

Who cannot take part

  • ✗Exclusively ocular myasthenia gravis (MGFA I), mild symptoms (MGFA II), or severe bulbar disease or MG crisis, MGFA...
  • ✗History of bone marrow/hematopoietic stem cell or solid organ transplantation.
  • ✗Other uncontrolled disease states, such as asthma, or inflammatory bowel disease, where flares are commonly treated...
  • ✗Participants with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune...
  • ✗Prior treatment with anti-CD19 therapy, adoptive T cell therapy or any prior gene therapy product (e.g. CAR-T cell...
See the full criteria
Inclusion Criteria: 1. 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 2. MGFA Class III-IVa (gMG) at screening 3. 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. 4. 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 5. If treated with cholinesterase inhibitors, patients must be on a stable dose for at least two weeks prior to screening Exclusion Criteria: 1. Exclusively ocular myasthenia gravis (MGFA I), mild symptoms (MGFA II), or severe bulbar disease or MG crisis, MGFA Class IVb or V at screening 2. History of bone marrow/hematopoietic stem cell or solid organ transplantation. 3. 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 4. Other uncontrolled disease states, such as asthma, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids, at screening 5. Participants with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune deficiency), or tested positive for HIV antibody, at screening 6. 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

Where Is This Study? (2 UK sites)

Novartis Investigative Site

Sheffield S10 2JF, United Kingdom

Novartis Investigative Site

London SE5 9RS, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-08