LUCAR-DKS1 for relapsed or treatment-resistant autoimmune diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm, open-label, dose-escalation early-phase trial testing LUCAR-DKS1, a chimeric antigen receptor (CAR) NK-cell therapy, in adults with relapsed or refractory autoimmune diseases. Participants will undergo screening, receive lymphodepleting chemotherapy, then a single infusion of LUCAR-DKS1 followed by planned follow-up visits to monitor safety, pharmacokinetics, and signals of efficacy. The protocol enrolls patients meeting disease-specific classification criteria (for SLE, AAV, SSc, or IIM) with relevant antibody or marker positivity and acceptable laboratory parameters. The primary focus is on safety and tolerability, with secondary collection of pharmacologic and preliminary effectiveness data.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
  Hefei, Anhui, China Recruiting
• Jiangsu Province Hospital
  Nanjing, Jiangsu, China Recruiting
• The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting
• The Third The People's Hospital of BengBu
  Bengbu, Anhui, China Not yet recruiting
• The First Affiliated Hospital of Wenzhou Medical University
  Wenzhou, Zhejiang, China Not yet recruiting

Study contacts

• Principal investigator: Wenfeng Tan Principal Investigator — The First Affiliated Hospital with Nanjing Medical University
• Study coordinator: Wenbo Hu
• Email: wenbo.hu@legendbiotech.cn
• Phone: 13581888439

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• LCAR-F33S for relapsed or refractory multiple myeloma.

  This trial will test an experimental LCAR-F33S cell infusion to see if it is safe and can shrink tumors in adults with relapsed or refractory multiple myeloma.

  Recruiting at 3 sites Nanjing Legend Biotech Co. · Beijing and 3 other locations · NCT07100067

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.