A Study of LUCAR-DKS1 in Subjects With Relapsed/Refractory Autoimmune Diseases
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNanjing Legend Biotech Co.
About this trial
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
This trial does not accept healthy volunteersQualifiers
Subjects voluntary agreement to provide written informed consent.
Aged 18 to 70 years, either sex.
Clinical laboratory values meet screening criteria.
Positive test for CD19 and/ or BCMA
Disqualifiers
Active infections such as hepatitis and tuberculosis.
Other autoimmune diseases.
Serious underlying diseases such as tumor, uncontrolled diabetes.
Female subjects who were pregnant, breastfeeding.
Trial design
Design model
Sequential
Treatments tested in this trial
LUCAR-DKS1 NK cells
Biological/VaccinePrior to the infusion of the LUCAR-DKS1 cells, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: Chimeric antigen receptor NK cells (LUCAR-DKS1), single-dose for each subject.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence, severity, and type of treatment-emergent adverse events (TEAEs) .
≥Grade 1 clinical symptoms, laboratory test abnormalities, and clinical events that are possibly, likely, or definitely related to study treatment. Accessed by CTCAE5.0.
Time frame
About 2 years after LUCAR-DKS1infusion (Day 1)2
Incidence of dose-limiting toxicity (DLT)
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.
Time frame
About 2 years after LUCAR-DKS1 infusion (Day 1)3
Cmax
CAR positive NK cells in peripheral blood after LUCAR-DKS1 infusion, maximum concentration (Cmax).
Time frame
About 2 years after LUCAR-DKS1 infusion (Day 1)4
Tmax
CAR positive NK cells levels in peripheral blood after LUCAR-DKS1 infusion, time to Cmax (Tmax).
Time frame
About 2 years after LUCAR-DKS1 infusion (Day 1)Secondary outcomes
1
SLE disease activity: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline up to 2 years, a total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.
Time frame
About 2 years after LUCAR-DKS1infusion (Day 1)2
SSc disease activity :Modified rodnan skin score(mRSS)
Change in modified Rodnan skin score (mRSS) from baseline up to 2 years in SSc patients. The mRSS is used to assess skin thickness and scope of SSc patients ,with a total score can fall between 0 and 51, with a higher score representing a more significant degree of skin involvement.
Time frame
About 2 years after LUCAR-DKS1 infusion (Day 1)3
AAV disease activity： Birmingham vasculitis activity score (BVAS)
Change in Birmingham vasculitis activity score (BVAS) from baseline up to 2 years in patients with AAV. A total score can fall between 0 and 64, with a higher score representing a more significant degree of disease activity.
Time frame
About 2 years after LUCAR-DKS1 infusion (Day 1)4
IIM disease activity ：Manual muscle test-8
Change in manual muscle testing (MMT-8) score from baseline up to 2 years in IIM patients. This tool assesses muscle strength by testing 8 proximal, distal, and axial muscles ,assess unilateral(score range 0-80 points)handedness side, with a lower score representing a more significant degree of muscle involvement.
Time frame
About 2 years after LUCAR-DKS1 infusion (Day 1)Sponsors and contacts
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Source ClinicalTrials.gov