Clinical Study of Cizutamig in Generalized Myasthenia Gravis (gMG)

NCT07215650 | Recruiting Phase 1

• 1 other identifier: CND106-107
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Generalized Myasthenia Gravis

Outcome Measures

Primary Outcomes (11)

• Incidence and severity of treatment-emergent adverse events through end of study

  Baseline to Month 12

• Changes from baseline in vital signs through end of study: body temperature

  Baseline to Month 12

• Changes from baseline in vital signs through end of study: heart rate

  Baseline to Month 12

• Changes from baseline in vital signs through end of study: respiratory rate

  Baseline to Month 12

• Changes from baseline in vital signs through end of study: blood pressure

  Baseline to Month 12

• Changes from baseline in vital signs through end of study: pulse oximetry

  Baseline to Month 12

• Changes from baseline in ECG parameters through end of study: PR interval

  Baseline to Month12

• Changes from baseline in ECG parameters through end of study: QRS interval

  Baseline to Month 12

• Changes from baseline in ECG parameters through end of study: QTcF interval

  Baseline to Month 12

• Changes from baseline in safety laboratory assessments through end of study: serum chemistry

  Baseline to Month 12

• Changes from baseline in safety laboratory assessments through end of study: hematology

  Baseline to Month 12

Secondary Outcomes (6)

• Pharmacokinetic (PK) parameters for Cizutamig: Cmax

  Baseline to Month 12

• PK parameters for Cizutamig: time of maximum concentration

  Baseline to Month 12

• PK parameters for Cizutamig: area under the concentration-time curve

  Baseline to Month 12

• PK parameters for Cizutamig: clearance

  Baseline to Month 12

• PK parameters for Cizutamig: volume of distribution

  Baseline to Month 12

Study Arms (1)

Cizutamig

EXPERIMENTAL

Drug: Cizutamig

Interventions

Cizutamig DRUG

Cizutamig will be dosed according to the protocol

Also known as: CND106

Cizutamig

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old at the time of signing the Informed Consent Form (ICF);
• Diagnosed with MG, classified as MGFA Class II-IVa, and judged by the investigator as unlikely to require respiratory support during the study;
• 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;
• 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.

You may not qualify if:

• Any history of CAR-T or TCE therapy targeting any antigen or BCMA-targeted therapy;
• 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;
• 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;
• Participation in any investigational trial involving biological agents within 12 weeks or 5 half-lives (whichever is longer) of the IP before screening;
• Administration of live vaccines within 4 weeks before screening;
• History of progressive multifocal leukoencephalopathy;
• History of primary immunodeficiency (e.g., hypogammaglobulinemia) or hereditary complement deficiency;
• Presence of one or more significant concurrent diseases, as judged by the investigator, including but not limited to:
• Poorly controlled diabetes
• Chronic kidney disease stages IIIb, IV, or V
• Severe chronic pulmonary disease (e.g., requiring supplemental oxygen) or respiratory failure
• 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.

Sponsors & Collaborators

• Candid Therapeutics: lead

Study Sites (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

xiao dai

CONTACT

+8618521520014; xiao@candidrx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 10, 2025
• Study Start: September 16, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)