Health TrialsbyHealthPanel

Clinical Study of Cizutamig in Generalized Myasthenia Gravis (gMG)

ConditionGeneralized Myasthenia Gravis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCandid Therapeutics

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Cizutamig

    Drug

    Cizutamig will be dosed according to the protocol

Treatment groups

44 Participants
are divided into 1 treatment group
Group A: CizutamigExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline to Month 12
2

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

Time frame
Baseline to Month 12
3

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

Time frame
Baseline to Month 12
4

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

Time frame
Baseline to Month 12

Secondary outcomes

1

Pharmacokinetic (PK) parameters for Cizutamig: Cmax

Time frame
Baseline to Month 12
2

PK parameters for Cizutamig: time of maximum concentration

Time frame
Baseline to Month 12
3

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

Time frame
Baseline to Month 12
4

PK parameters for Cizutamig: clearance

Time frame
Baseline to Month 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Candid Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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