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NCT Number: NCT07095075

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

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.

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Key information

Conditions

Relapsed/Refractory Autoimmune Diseases Autoimmune Diseases Immune System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

The Third The People's Hospital of BengBu, Bengbu, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:
  • Subjects voluntary agreement to provide written informed consent.
  • Aged 18 to 70 years, either sex.
  • Clinical laboratory values meet screening criteria.
  • 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-Smith antibody 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 at screening.
  • 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 at screening.
  • 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 criteria

  • Active infections such as hepatitis and tuberculosis.
  • Other autoimmune diseases.
  • Serious underlying diseases such as tumor, uncontrolled diabetes.
  • Female subjects who were pregnant, breastfeeding.
  • Those with a history of major organ transplantation.
  • Have received autologous cell therapy of any target before.

Treatment and study plan

LUCAR-DKS1 NK cells

Biological

Prior to the infusion of the LUCAR-DKS1 cells, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.

Primary outcomes

  1. Incidence, severity, and type of treatment-emergent adverse events (TEAEs) .

    Time frame: About 2 years after LUCAR-DKS1infusion (Day 1)

    ≥Grade 1 clinical symptoms, laboratory test abnormalities, and clinical events that are possibly, likely, or definitely related to study treatment. Accessed by CTCAE5.0.

  2. Incidence of dose-limiting toxicity (DLT)

    Time frame: About 2 years after LUCAR-DKS1 infusion (Day 1)

    DLTs are severe adverse events that refers to any untoward medical occurred in a subject participated in a clinical investigation, which have a causal relationship with the treatment and will limit the dose escalation.

  3. Cmax

    Time frame: About 2 years after LUCAR-DKS1 infusion (Day 1)

    CAR positive NK cells in peripheral blood after LUCAR-DKS1 infusion, maximum concentration (Cmax).

  4. Tmax

    Time frame: About 2 years after LUCAR-DKS1 infusion (Day 1)

    CAR positive NK cells levels in peripheral blood after LUCAR-DKS1 infusion, time to Cmax (Tmax).

  5. AUC

    Time frame: About 2 years after LUCAR-DKS1 infusion (Day 1)

    CAR positive NK cells levels in peripheral blood after LUCAR-DKS1 infusion， area under the concentration-time curve (AUC) .

  6. Recommended phase 2 dose regimen finding

    Time frame: About 2 years after LUCAR-DKS1 infusion (Day 1)

    Recommended phase 2 dose regimen established through dose exploratoration finding.

Secondary outcomes

  1. SLE disease activity: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)

    Time frame: About 2 years after LUCAR-DKS1infusion (Day 1)

    Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline up to 2 years, a total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.

  2. SSc disease activity :Modified rodnan skin score(mRSS)

    Time frame: About 2 years after LUCAR-DKS1 infusion (Day 1)

    Change in modified Rodnan skin score (mRSS) from baseline up to 2 years in SSc patients. The mRSS is used to assess skin thickness and scope of SSc patients ,with a total score can fall between 0 and 51, with a higher score representing a more significant degree of skin involvement.

  3. AAV disease activity： Birmingham vasculitis activity score (BVAS)

    Time frame: About 2 years after LUCAR-DKS1 infusion (Day 1)

    Change in Birmingham vasculitis activity score (BVAS) from baseline up to 2 years in patients with AAV. A total score can fall between 0 and 64, with a higher score representing a more significant degree of disease activity.

  4. IIM disease activity ：Manual muscle test-8

    Time frame: About 2 years after LUCAR-DKS1 infusion (Day 1)

    Change in manual muscle testing (MMT-8) score from baseline up to 2 years in IIM patients. This tool assesses muscle strength by testing 8 proximal, distal, and axial muscles ,assess unilateral(score range 0-80 points)handedness side, with a lower score representing a more significant degree of muscle involvement.

  5. SjS disease activity: Sjögren's Tool for Assessing(STAR)

    Time frame: About 2 years after LUCAR-DKS1 infusion (Day 1)

    Proportion and duration of Sjögren's syndrome(r/r SjS) subjects achieving Sjögren's Tool for Assessing Response(STAR) response from baseline up to 2 years. STAR can be used to assess the treatment response of all SjS patients. It is generally believed that a STAR score of ≥ 5 is an effective response to treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Liyuan Yu

CONTACT

[email protected]

18618406418

Wenbo Hu

CONTACT

[email protected]

13581888439

Sponsors and collaborators

Lead sponsor

Nanjing Legend Biotech Co.

Industry

Registry information

Official study title

An Open-label Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LUCAR-DKS1 in Subjects With Relapsed/Refractory Autoimmune Diseases (r/r AID)

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 31, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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