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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Withdrawn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

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of USTC(Anhui Provincial Hospital)HefeiChinaUnknown status
Jiangsu Province HospitalNanjingChinaUnknown status
The 1st Affiliated Hospital of WHUWenzhouChinaUnknown status
The affiliated hospital of xuzhou medical universityXuzhouChinaUnknown status

Are you the coordinator? Confirm the details

This page is information, not medical advice. Discuss any trial with your doctor.