NCT06866080WithdrawnEarly phase 1
A Study of LCAR-AIO in Subjects With Relapsed/Refractory Autoimmune Diseases
An Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LCAR-AIO for the Treatment of Relapsed/Refractory Autoimmune Diseases (r/r AID)
Source: ClinicalTrials.gov · Last updated 8 Jul 2025
Reason given: Discontinue further development of LCAR-AIO program
Brief summary (registry, in English)
This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory autoimmune diseases.
- Status (registry)
- Withdrawn
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 4 Mar 2025
- Start date
- 17 Jun 2025
- Primary completion date
- 17 Jun 2025
- Lead sponsor
- Nanjing Legend Biotech Co.
- NCT number
- NCT06866080
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving LCAR-AIO treatment.
Other illness
- Active infections such as hepatitis and tuberculosis.
- Other autoimmune diseases.
- Serious underlying diseases such as tumor, uncontrolled diabetes.
Other
- Participated in other clinical trials within 4 weeks.
Who the study is looking for
- Subjects voluntarily participate in clinical research.
- Age 18-65 years.
- Adequate organ function at screening.
- Clinical laboratory values meet criteria at screening.
- 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.
- AAV:
- Have been diagnosed of AAV before screening.
- Positive test for anti-PR3 or anti-MPO antibodies at screening.
- Fulfill relapsed/refractory AAV conditions.
- SSc:
- Have been diagnosed of SSc before screening.
- At screening, mRSS is higher than 10.
- Fulfill relapsed/refractory SSc 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 65 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of USTC(Anhui Provincial Hospital) | Hefei | China | Unknown status |
| Jiangsu Province Hospital | Nanjing | China | Unknown status |
| The 1st Affiliated Hospital of WHU | Wenzhou | China | Unknown status |
| The affiliated hospital of xuzhou medical university | Xuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.