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Recruiting NCT07095075

A Study of LUCAR-DKS1 in Subjects With Relapsed/Refractory Autoimmune Diseases

Early Phase I Interventional Relapsed/Refractory Autoimmune Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LUCAR-DKS1 NK cells.
Who it may be relevant to
Registry conditions: Relapsed/Refractory Autoimmune Diseases. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-label Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LUCAR-DKS1 in Subjects With Relapsed/Refractory Autoimmune Diseases (r/r AID)

Overview

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.

Detailed description

This is a prospective, single-arm, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LUCAR-DKS1, a chimeric antigen receptor (CAR) -NK cell therapy in subjects with relapsed/refractory autoimmune diseases. Patients who meet the eligibility criteria will receive LUCAR-DKS1 infusion. The study will include the following sequential stages: screening, pre-treatment (lymphodepleting chemotherapy), treatment LUCAR-DKS1 infusion) and follow-up.

Interventions

  • Biological 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.

Primary outcome measures

  • Incidence, severity, and type of treatment-emergent adverse events (TEAEs) . [Time frame: About 2 years after LUCAR-DKS1infusion (Day 1)]
  • Incidence of dose-limiting toxicity (DLT) [Time frame: About 2 years after LUCAR-DKS1 infusion (Day 1)]
  • Cmax [Time frame: About 2 years after LUCAR-DKS1 infusion (Day 1)]
  • Tmax [Time frame: About 2 years after LUCAR-DKS1 infusion (Day 1)]
  • AUC [Time frame: About 2 years after LUCAR-DKS1 infusion (Day 1)]
  • Recommended phase 2 dose regimen finding [Time frame: About 2 years after LUCAR-DKS1 infusion (Day 1)]
Secondary outcome measures (5)
  • SLE disease activity: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) [Time frame: About 2 years after LUCAR-DKS1infusion (Day 1)]
  • SSc disease activity :Modified rodnan skin score(mRSS) [Time frame: About 2 years after LUCAR-DKS1 infusion (Day 1)]
  • AAV disease activity： Birmingham vasculitis activity score (BVAS) [Time frame: About 2 years after LUCAR-DKS1 infusion (Day 1)]
  • IIM disease activity ：Manual muscle test-8 [Time frame: About 2 years after LUCAR-DKS1 infusion (Day 1)]
  • SjS disease activity: Sjögren's Tool for Assessing(STAR) [Time frame: About 2 years after LUCAR-DKS1 infusion (Day 1)]

Eligibility criteria

  • Inclusion Criteria:
  • 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

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

  • Active infections such as hepatitis and tuberculosis.
  • Other autoimmune diseases.
  • Serious underlying diseases such as tumor, uncontrolled diabetes.
  • Female subjects who were pregnant, breastfeeding.
  • Those with a history of major organ transplantation.
  • Have received autologous cell therapy of any target before.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 5 centers
  • The Third The People's Hospital of BengBu — Bengbu
  • The First Affiliated Hospital of USTC (Anhui Provincial Hospital) — Hefei
  • Jiangsu Province Hospital — Nanjing
  • The First Affiliated Hospital of Soochow University — Suzhou
  • The First Affiliated Hospital of Wenzhou Medical University — Wenzhou

Identifiers

NCT: NCT07095075 · LB2405-0001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗