NCT06946199 An Open-label Study of Cizutamig in Refractory Seropositive Rheumatoid Arthritis
| NCT ID | NCT06946199 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | Rheumatoid Arthritis (RA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2025-06-23 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 28 participants in total. It began in 2025-06-23 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to evaluate the safety and efficacy of BCMAxCD3 T-cell engager (cizutamig) in patients with refractory seropositive RA.
Eligibility Criteria
Inclusion Criteria: 1. 18 to 75 years old at the time of signing the informed consent form 2. Diagnosis of adult-onset RA as defined by the 2010 ACR/EULAR classification criteria 3. Moderately to severely active RA. 4. Positive test results for RF and/or ACPA at Screening. Inadequate treatment response defined as either lack of clinical benefit or intolerability to treatment with tsDMARD and/or bDMARD Exclusion Criteria: 1. Inadequate clinical laboratory parameters at Screening 2. Patients with active infection 3. Receipt of live vaccine within 4 weeks prior to Screening 4. Presence of any concomitant autoimmune disease 5. History of progressive multifocal leukoencephalopathy 6. History of primary immunodeficiency or a hereditary deficiency of the complement system 7. Central nervous system disease 8. Presence of 1 or more significant concurrent medical conditions per investigator judgment 9. Have a diagnosis or history of malignant disease within 5 years 10. 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
Contact & Investigator
Qiubai Li, Professor
PRINCIPAL INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Frequently Asked Questions
Who can join the NCT06946199 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Rheumatoid Arthritis (RA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06946199 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06946199 currently recruiting?
Yes, NCT06946199 is actively recruiting participants. Contact the research team at qiubaili@hust.edu.cn for enrollment information.
Where is the NCT06946199 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06946199 clinical trial?
NCT06946199 is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The principal investigator is Qiubai Li, Professor at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 28 participants.
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