A Study of LUCAR-DKS1 in Subjects With Relapsed/Refractory Autoimmune Diseases

Last updated: December 9, 2025
Sponsor: Nanjing Legend Biotech Co.
Overall Status: Active - Recruiting

Phase

1

Condition

Connective Tissue Diseases

Collagen Vascular Diseases

Treatment

LUCAR-DKS1 NK cells

Clinical Study ID

NCT07095075
LB2405-0001
  • Ages 18-70
  • All Genders

Study Summary

This is a prospective, single-arm, open-label and dose-escalation Investigator Initialed study to evaluate LUCAR-DKS1 in adult subjects with relapsed/refractory autoimmune diseases.

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  1. Subjects voluntary agreement to provide written informed consent.

  2. Aged 18 to 70 years, either sex.

  3. Clinical laboratory values meet screening criteria.

  4. Positive test for CD19 and/ or BCMA

SLE:

  • Meets at least 1 classification criteria≥6 months for SLE.

  • At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smithantibody should be positive.

  • Fulfill relapsed/refractory SLE conditions.

AAV:

  • Meets the 2022 ACR/EULAR classification criteria for AAV.

  • Positive test for anti-MPO or p-ANCA or anti-PR3 or anti-MPO antibodies atscreening.

  • Fulfill relapsed/refractory AAV conditions.

SSc:

  • Meets the 2013 ACR/EULAR classification criteria for SSc.

  • At screening, mRSS is higher than 10.

  • Fulfill relapsed/refractory SSc conditions.

IIM:

  • Meets 2017 EULAR/ACR classification criteria for IIM.

  • Positive test for myositis-associated antibodies or myositis-specific antibodies atscreening.

  • Fulfill relapsed/refractory IIM conditions. SjS:

  • Meets the 2016 ACR/EULAR diagnostic criteria for SjS.

  • Positive test for anti-SSA and/or anti-SSB antibodies at screening.

  • Fulfill relapsed/refractory SjS conditions.

Exclusion

Exclusion Criteria:

  1. Active infections such as hepatitis and tuberculosis.

  2. Other autoimmune diseases.

  3. Serious underlying diseases such as tumor, uncontrolled diabetes.

  4. Female subjects who were pregnant, breastfeeding.

  5. Those with a history of major organ transplantation.

  6. Have received autologous cell therapy of any target before.

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: LUCAR-DKS1 NK cells
Phase: 1
Study Start date:
October 14, 2025
Estimated Completion Date:
December 31, 2029

Study Description

This is a prospective, single-arm, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LUCAR-DKS1, a chimeric antigen receptor (CAR) -NK cell therapy in subjects with relapsed/refractory autoimmune diseases. Patients who meet the eligibility criteria will receive LUCAR-DKS1 infusion. The study will include the following sequential stages: screening, pre-treatment (lymphodepleting chemotherapy), treatment LUCAR-DKS1 infusion) and follow-up.

Connect with a study center

  • The Third The People's Hospital of BengBu

    Bengbu, Anhui 233000
    China

    Site Not Available

  • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

    Hefei, Anhui 230036
    China

    Site Not Available

  • The Third The People's Hospital of BengBu

    Bengbu 1816440, Anhui 1818058 233000
    China

    Site Not Available

  • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

    Hefei 1808722, Anhui 1818058 230036
    China

    Active - Recruiting

  • Jiangsu Province Hospital

    NanJing, Jiangsu 210029
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing 1799962, Jiangsu 1806260 210029
    China

    Active - Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou 1886760, Jiangsu 1806260 215006
    China

    Active - Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325015
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou 1791388, Zhejiang 1784764 325015
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.