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Tests treatment safety and results for Generalized Myasthenia Gravis
Official title Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB323 in Generalized Myasthenia Gravis
ClinicalTrials.gov ID: NCT06704269
What this study is testing
What is YTB323?
YTB323 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for generalized myasthenia gravis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- 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...
- Other uncontrolled disease states, such as asthma, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral...
- Participants with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune deficiency), or tested positive for HIV...
- 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...
See the full eligibility criteria
- 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...
- 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...
- If treated with cholinesterase inhibitors, patients must be on a stable dose for at least two weeks prior to screening
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- Winston-Salem, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Bordeaux, France
- Brest, France
- Lille, France
- Chiba, Chiba, Japan
- Kyoto, Japan
- Sheffield, South Yorkshire, United Kingdom
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States; Winston-Salem, North Carolina, United States; Philadelphia, Pennsylvania, United States; Houston, Texas, United States; Bordeaux, France; Brest, France and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.