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Clinical Trials in China / NCT07215650
Recruiting Phase 1

Clinical Study of Cizutamig in Generalized Myasthenia Gravis (gMG)

NCT07215650 · tracked via the Priya Life Science China tracker
Sponsor
Candid Therapeutics
Phase
Phase 1
Started
2025-09-16
Last updated
2026-09-02

Condition(s) studied

Generalized Myasthenia Gravis

Investigational drug(s) / intervention(s)

Cizutamig

Cizutamig: Cizutamig will be dosed according to the protocol

Study summary

The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of Cizutamig in patients with Generalized Myasthenia Gravis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. At least 18 years old at the time of signing the Informed Consent Form (ICF); 2. Diagnosed with MG, classified as MGFA Class II-IVa, and judged by the investigator as unlikely to require respiratory support during the study; 3. At screening, the Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥ 5, with non-ocular items accounting for ≥ 50% of the total score, and GMG ≥ 11; 4. Inadequate response to conventional therapies or lack of effective treatment options, defined as disease recurrence or progression despite treatment with corticosteroids, immunosuppressants (e.g., azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine A, methotrexate), or biologics (e.g., rituximab), and/or lack of effective treatment methods. Exclusion Criteria: 1. Any history of CAR-T or TCE therapy targeting any antigen or BCMA-targeted therapy; 2. Use of any approved immunosuppressive drugs not listed here within 12 weeks or 5 half-lives (whichever is longer) before screening, unless approved by the medical monitor; 3. Participation in any investigational trial involving non-biological agents within 4 weeks or 5 half-lives (whichever is longer) of the investigational product (IP) before screening; 4. Participation in any investigational trial involving biological agents within 12 weeks or 5 half-lives (whichever is longer) of the IP before screening; 5. Administration of live vaccines within 4 weeks before screening; 6. History of progressive multifocal leukoencephalopathy; 7. History of primary immunodeficiency (e.g., hypogammaglobulinemia) or hereditary complement deficiency; 8. Presence of one or more significant concurrent diseases, as judged by the investigator, including but not limited to: 1. Poorly controlled diabetes 2. Chronic kidney disease stages IIIb, IV, or V 3. Severe chronic pulmonary disease (e.g., requiring supplemental oxygen) or respiratory failure 9. Any severe medical condition or clinically significant laboratory abnormality that, in the judgment of the investigator or medical monitor, would compromise the patient's safe participation and completion of the study or may affect protocol compliance or interpretation of study results.

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
Union Hospital Affiliated to Fujian Medical University Fuzhou Fujian Recruiting
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine Guangzhou Guangdong Recruiting
The Third Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong Recruiting
The Affiliated Hospital of Guizhou Medical University Guiyang Guizhou Recruiting
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan Recruiting
The First Hospital of Jilin University Changchun Jilin Recruiting
Huashan Hospital Affiliated to Fudan University Shanghai Shanghai Municipality Recruiting
The First Hospital of Shanxi Medical University Taiyuan Shanxi Recruiting
Sichuan Provincial People's Hospital Chengdu Sichuan Recruiting
Tianjin Medical University General Hospital Tianjin Tianjin Municipality Recruiting

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07215650 on ClinicalTrials.gov ↗ ← All trials in China