BridgeMD
An open-label study to assess safety, efficacy, and cellular kinetics of YTB323 in treatment-resistant generalized myasthenia gravis
EU CTIS ID: 2024-513589-20-00
What this study is testing
To assess the safety of YTB323 in patients with treatment-resistant generalized myasthenia gravis (gMG) with antibodies against AChR or MuSK.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent, and able to communicate well with the investigator and comply with the requirements of the study
- Male or female participants 18-65 years of age with adequate renal, hepatic, cardiac, hematological, and pulmonary function (see definitions in Section 5.1)
- Confirmed gMG diagnosis with documented positive AChR antibodies or MuSK antibodies at screening AND has one of the following: history of abnormal neuromuscular transmission test demonstrated by repetitive nerve stimulation or single-fiber electromyography OR history of positive acetylcholinesterase test OR improvement in MG signs on an oral acetylcholinesterase inhibitor as assessed by the treating physician
- Generalized myasthenia gravis classified as MGFA Class III-IVa at screening
- Treatment-resistant gMG as defined by: MG-ADL score ≥6 at screening despite adequate treatment trials with at least two different non-steroidal immunosuppressive drugs given at adequate doses and duration of therapy. Specifically, they must have failed treatment with at least one oral immunomodulatory or steroid-sparing drug (e.g., azathioprine, mycophenolate mofetil, tacrolimus) AND EITHER one approved anti-C5 complement antibody (e.g., eculizumab, ravulizumab) OR an approved FcRn antagonist OR rituximab, OR required two or more rescue therapies (plasma exchange/immunoadsorption or IVIg) for myasthenic worsening/crisis in the 12 months before screening
- If on chronic corticosteroids, ability and willingness to taper to a maximum dose at least one week before leukapheresis
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 time of screening)
- Clinically significant active, opportunistic, chronic or recurrent infection (including positive for hepatitis B or hepatitis C, HIV or TB)
- History of malignancy of any organ system (other than complete resection of localized basal cell carcinoma of the skin or in situ cervical cancer or non-invasive malignant polyps that have been removed), treated or untreated, within the past 5 years
- Known thymic neoplasm or history of thymectomy within 12 months prior to screening
- Prior treatment with anti-CD19 therapy, adoptive T cell therapy or any prior gene therapy product (e.g. CAR-T cell therapy)
- Hypersensitivity and/or contraindications to any product (including its ingredients) to be given to the participant as per the study protocol (e.g., YTB323, tocilizumab, lymphodepleting agents, etc.) or any condition that, in the Investigator's opinion, precludes lymphodepleting chemotherapy
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United States
- 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, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.