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
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
* 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
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.
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