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New lupus drug cizutamig enters early human safety trials

NCT ID NCT07215663

Disease control Sponsor: Candid Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This early-stage study is testing a new drug called cizutamig in about 47 adults with systemic lupus erythematosus (SLE), a chronic autoimmune disease. The main goal is to check if the drug is safe and tolerable, and to see how it moves through the body. Participants must have active lupus that hasn't responded well enough to prior treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 47 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 18 to 75 years old at the time of signing the informed consent form 2. Diagnosis of SLE according to the ACR/EULAR classification criteria 3. Positive anti-dsDNA or positive anti-Smith antibodies AND positive for at least one other of anti-dsDNA, anti-Smith antibodies, or ANA ≥1:80 at screening 4. SLEDAI-2K total score ≥6 and SLEDAI-2K clinical score≥4 at Screening 5. The investigator judged that the patient had an inadequate response to prior treatment for at least 3 months before screening 6. Stable use of concomitant therapies 7. For patients with active LN only: LN Class III or IV Exclusion Criteria: 1. Inadequate clinical laboratory parameters at Screening 2. Active infection 3. Receipt of or inability to discontinue any excluded therapies 4. Receipt of live vaccine within 4 weeks prior to Screening 5. Presence of any concomitant autoimmune disease 6. Active or known history of catastrophic anti-phospholipid syndrome (APS) 7. APS or thrombotic event not adequately controlled by anticoagulation therapy 8. History of progressive multifocal leukoencephalopathy 9. History of primary immunodeficiency or a hereditary deficiency of the complement system 10. Central nervous system disease 11. Presence of 1 or more significant concurrent medical conditions 12. Have a diagnosis or history of malignant disease within 5 years 13. Serious mental illness, alcohol or drug abuse, dementia, or any other condition that would impair the patient's ability to receive the planned treatment or to understand informed consent at the study site as determined by local practice 14. Inability to comply with protocol-mandated requirements 15. History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or any constituents of cizutamig 16. History of or planned organ transplant and/or autologous or allogeneic hematopoietic stem cell transplantation 17. Major surgery requiring use of general anesthesia within 12 weeks or planned or expected major surgery during the study 18. Women who are pregnant or breastfeeding 19. Patients who do not agree to the use of highly effective contraception as defined by the protocol 20. Individuals considered to be part of a vulnerable population (eg, incarceration)

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus (SLE)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chinese Academy of Medical Sciences and Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Guangdong Provincial People's Hospital

    RECRUITING

    Guangzhou, Guangdong, China

  • Henan University of Science and Technology-The First Affiliated Hospital

    RECRUITING

    Luoyang, Henan, China

  • Nanfang Hospital Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, China

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Second Hospital of Shanxi Medical University

    RECRUITING

    Taiyuan, Shanxi, China

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, China

  • The First Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, China

  • The First Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, China

  • The Second Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi’an, Shanxi, China

  • The Third Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, China

  • Tianjin Medical University General Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, China

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, China

  • Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, China

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