Generalized Myasthenia Gravis
Conditions
Interventions
The study plan involves administering drugs in different dose groups:Cizutamig Intravenous injection
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Is at least 18 years of age at the time of signing the informed consent form (ICF); 2. Has a diagnosis of gMG, defined by the MGFA as Class II to IVa and is unlikely to need respiratory support during the study as determined by the investigator. a. Diagnosis must be confirmed with the following: Positive serologic test for AChR or MuSK defined as >ULN at screening; 3. Total Myasthenia Gravis-Activities of Daily Living (MG-ADL) score >= 5 at screening and Day 1, with >= 50% of the score derived from non-ocular symptoms; and QMG score >= 11; 4. Inadequate response to standard regimen of conventional treatment, defined as recurrence or aggravation of disease despite treatment with glucocorticoids, immunosuppressants (such as azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine A, methotrexate, etc.) or biological agents (such as rituximab) as specified below, and/or lack of effective treatment options. a. Azathioprine: for >= 6 months of treatment before Screening, and a stable dose for >= 2 months. b. Other immunosuppressive agents (eg, mycophenolate mofetil, cyclosporine, tacrolimus): for >= 3 months of treatment before Screening, and a stable dose for >= 4 weeks. c. AChE Inhibitors: for a stable dose >= 2 weeks before Screening. d. Glucocorticoids: for >= 3 months of treatment before Screening, and a stable dose (oral prednisone = 4 weeks.
Exclusion criteria
Exclusion criteria: 1. Laboratory indicators at screening: a. Peripheral B cell count 2 times ULN (or Total bilirubin >2.5 times ULN) eGFR <= 60 mL/min/1.73m^2 as calculated by the CKD-EPI equation 2. Patients will be excluded if they are known to have any of the following: a. Any known HIV infection or positive HIV 1 or 2 antibody at Screening b. Positive HBsAg. Patients with positive HBcAb must be tested for HBV-DNA to determine their status; if HBV-DNA is positive, patients should be excluded; If HBV-DNA is negative, the patient may participate in the study. c. Patients with positive HCV antibody must be tested for HCV ribonucleic acid (RNA); if HCV RNA is also positive, patients should be excluded; if HCV RNA is negative, the patient may participate in the study. d. Active tuberculosis (TB) or lack of documentation of completion of treatment for active TB. If the TB test (QuantiFERON® Gold Test or T-SPOT) is positive, patients may have a chest X-ray to rule out latent or active TB if required by local guidelines/standard of care. If the test result is positive and a chest X-ray is negative for active TB, the patient will be allowed to enroll with documentation of completed treatment for active TB or latent TB. ? If the test result is indeterminant, the site should repeat the test. ? A positive test result or 2 successive indeterminant results should be considered as a positive result. ? An indeterminant test result followed by a negative test result should be considered as a negative test result. Patients with latent TB ? With documented completion of anti-TB therapy prior to study participation may enroll in the study. ? Without documented treatment, patients will be considered a screen failure. e. Active infection with coronavirus 2 (SARS-CoV-2), influenza, or respiratory syncytial virus (RSV) defined by positive screening test. The patient may be enrolled if either asymptomatic, or afebrile off antipyretics and improving symptoms, for at least 1 week prior to first dose of cizutamig. f. Patients with symptoms and/or signs of confirmed or suspected infection or fever of 38°C or above, or receiving antimicrobials 1 week prior to first dose of cizutamig. g. Has had any of the following types of infection any time between 3 months prior to Screening and first dose of cizutamig: o Serious (requiring hospitalization or systemic use of antimicrobials for = 2 weeks o Opportunistic (including, but not limited to, pneumocystis jirovecii, cytomegalovirus, toxoplasmosis, histoplasmosis, herpes zoster, as defined in Winthrop et al, 2015) Note: Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over. o Recurring (including, but not limited to, herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis) Note: Patients with recurrent nonserious infections (eg urinary tract infection) may be enrolled at the discretion of the investigator if it does not place patients at an increased risk of complications. 3. Receipt of or inability to discontinue any of the following excluded therapies (except if indicated as recommended for acut
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs) through end of study;Changes from baseline in vital signs, electrocardiogram (ECG), and laboratory assessments through end of st; | — |
Countries
China
Contacts
Public ContactChongbo Zhao
Huashan Hospital, Fudan University
Outcome results
None listed