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

Plain-language summary

This study examines the LUCAR-DKS1 NK cell therapy in people with relapsed or refractory autoimmune diseases (such as systemic lupus, ANCA-associated vasculitis, and systemic sclerosis). It is open to people aged 18-70 who test positive for CD19 and/or BCMA and have one of the relevant autoimmune diagnoses. The study is being conducted in Early Phase 1 and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Early Phase 1

Status

Recruiting

Sponsor

Nanjing Legend Biotech Co.

Intervention

LUCAR-DKS1 NK cells

Start date

10/14/2025

Estimated completion

12/31/2029

Countries

China

Related genes

Locations

• Bengbu, China
• Hefei, China
• Nanjing, China
• Suzhou, China
• Wenzhou, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

* 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-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:

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.