NCT07095075 A Study of LUCAR-DKS1 in Subjects With Relapsed/Refractory Autoimmune Diseases
| NCT ID | NCT07095075 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Nanjing Legend Biotech Co. |
| Condition | Relapsed/Refractory Autoimmune Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-10-14 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2025-10-14 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Wenfeng Tan Principal Investigator
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Frequently Asked Questions
Who can join the NCT07095075 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Relapsed/Refractory Autoimmune Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07095075 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07095075 currently recruiting?
Yes, NCT07095075 is actively recruiting participants. Contact the research team at wenbo.hu@legendbiotech.cn for enrollment information.
Where is the NCT07095075 trial being conducted?
This trial is being conducted at Bengbu, China, Hefei, China, Nanjing, China, Suzhou, China and 1 additional location.
Who is sponsoring the NCT07095075 clinical trial?
NCT07095075 is sponsored by Nanjing Legend Biotech Co.. The principal investigator is Wenfeng Tan Principal Investigator at The First Affiliated Hospital with Nanjing Medical University. The trial plans to enroll 36 participants.