Clinical Trials in China / NCT07095075
Recruiting
Early Phase 1
A Study of LUCAR-DKS1 in Subjects With Relapsed/Refractory Autoimmune Diseases
NCT07095075 · tracked via the Priya Life Science China tracker
Condition(s) studied
Relapsed/Refractory Autoimmune Diseases
Investigational drug(s) / intervention(s)
LUCAR-DKS1 NK cells
LUCAR-DKS1 NK cells: Prior to the infusion of the LUCAR-DKS1 cells, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Study 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
* 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.
Primary outcome measure(s)
- Incidence, severity, and type of treatment-emergent adverse events (TEAEs) . — 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. - Incidence of dose-limiting toxicity (DLT) — 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. - Cmax — About 2 years after LUCAR-DKS1 infusion (Day 1)
CAR positive NK cells in peripheral blood after LUCAR-DKS1 infusion, maximum concentration (Cmax). - Tmax — 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). - AUC — 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) . - Recommended phase 2 dose regimen finding — About 2 years after LUCAR-DKS1 infusion (Day 1)
Recommended phase 2 dose regimen established through dose exploratoration finding.
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| The Third The People's Hospital of BengBu | Bengbu | Anhui | Not Yet Recruiting |
| The First Affiliated Hospital of USTC (Anhui Provincial Hospital) | Hefei | Anhui | Recruiting |
| Jiangsu Province Hospital | Nanjing | Jiangsu | Recruiting |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | Recruiting |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | Not Yet Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07095075 on ClinicalTrials.gov ↗ ← All trials in China