NCT07331272RecruitingPhase 1
A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)
An Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)
Source: ClinicalTrials.gov · Last updated 2 Feb 2026
Brief summary (registry, in English)
This is a prospective, single-arm, open-label and dose-escalation investigator initialed study to evaluate LUCAR-G79D in adult subjects with r/r SLE and r/r IIM.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- First submitted
- 15 Dec 2025
- Start date
- 29 Jan 2026
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- Nanjing Legend Biotech Co.
- Diseases
- Lupus (SLE)
- NCT number
- NCT07331272
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 38
- From 29 Jan 2026 to the primary completion date, 31 Jan 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active infections such as hepatitis and tuberculosis.
- Other autoimmune diseases.
- Serious underlying diseases such as tumor, uncontrolled diabetes.
- Those with a history of major organ transplantation.
Other
- Female subjects who were pregnant, breastfeeding.
Who the study is looking for
- Subjects voluntary agreement to provide written informed consent.
- Aged 18 to 70 years, either sex.
- Adequate organ function meet screening criteria.
- Positive test for cluster of differentiation antigen 19 (CD19).
- SLE:
- Have been diagnosed of SLE at least 6 months before screening.
- At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smith antibody should be positive.
- Fulfill relapsed/refractory SLE conditions.
- IIM:
- Have been diagnosed of IIM before screening.
- Positive test for myositis-associated antibodies or myositis-specific antibodies at screening.
- Fulfill relapsed/refractory IIM conditions.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Third The People's Hospital Of Bengbu Coordinator of this site? Confirm its status | Bengbu | China | Recruiting |
| Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| Nanfang Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Not yet recruiting |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.