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Relapsed/Refractory Autoimmune DiseasesEarly Phase 1NCT07095075

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

A Early Phase 1 study testing LUCAR-DKS1 NK cells in people with Relapsed/Refractory Autoimmune Diseases, run by Nanjing Legend Biotech Co. at 5 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Relapsed/Refractory Autoimmune Diseases
What is being tested?
LUCAR-DKS1 NK cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
5 sitesChina
Study dates
14 Oct 2025to 31 Dec 2029
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 23Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Wenbo Hu contact

13581888439

wenbo.hu@legendbiotech.cn

Liyuan Yu contact

18618406418

liyuan.yu@legendbiotech.cn

5 sites in 1 country

China5 sites, 5 recruiting

  • The Third The People's Hospital of BengBu

    Bengbu, Anhui, 233000

    Hanwei Wang

    Not yet recruiting

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

    Hefei, Anhui, 230036

    Zhu Chen

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Wenfeng Tan, 18061202878, tanwenfeng2005@126.com

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Jian Wu

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325015

    Li Sun

    Songfu Jiang

    Not yet recruiting

Other trials in China

About this study

Official 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)

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.

Read the detailed 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.

Being tested
LUCAR-DKS1 NK cells
Medical subject headings
Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LUCAR-DKS1 NK cellsBiological

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

Study groups in NCT07095075
Study groupRoleWhat they receive
Chimeric antigen receptor NK cells (LUCAR-DKS1), single-dose for each subject.ExperimentalExperimental: chimeric antigen receptor NK cells (LUCAR-DKS1). Dose level1：25 millions /kg Dose level2：50 millions /kg Dose level3：100 millions /kg Dose level4：200 millions /kg Dose level5：400 millions /kg Totally 5 dose groups, each subject will be given a single-dose LUCAR-DKS1 cells infusion at a certain level, subject will be administered at day 1.
Receives: Biological: LUCAR-DKS1 NK cells

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

  2. Incidence of dose-limiting toxicity (DLT)

    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.

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

  3. Cmax

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

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

  4. Tmax

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

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

  5. AUC

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

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

  6. Recommended phase 2 dose regimen finding

    Recommended phase 2 dose regimen established through dose exploratoration finding.

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

Secondary outcomes (5)

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

    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.

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

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

    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.

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

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

    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.

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

  4. IIM disease activity ：Manual muscle test-8

    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.

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

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

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2025
  2. Study start14 Oct 2025
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
This study is a dose exploration study that employs an accelerated titration design combined with BF-BOIN, planned to investigate 5 dose groups. Dose Level1 （25×10\^6 cells/kg) and Level 2(50×10\^6 cells/kg)belong to the accelerated titration method for dose assessment, three dosage levels of 100×10\^6 cells/kg, 200×10\^6 cells/kg, and 400×10\^6 cells/kg are assessed using the BOIN dose escalation and de-escalation rules.
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07095075
Sponsor's protocol ID
LB2405-0001
Status last verified
Dec 2025
First submitted
23 Jun 2025
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing LUCAR-DKS1 NK cells in people with Relapsed/Refractory Autoimmune Diseases, run by Nanjing Legend Biotech Co. at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wenbo Hu (13581888439, wenbo.hu@legendbiotech.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence, severity, and type of treatment-emergent adverse events (TEAEs) . (time frame: About 2 years after LUCAR-DKS1infusion (Day 1)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07095075.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.

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