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Recruiting NCT06653556

A Study of LCAR-AIO in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus

Early Phase I Interventional Systemic Lupus Erythematosus (SLE)

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: LCAR-AIO T cells.
Who it may be relevant to
Registry conditions: Systemic Lupus Erythematosus (SLE). Basic parameters: 18 years — 65 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 the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LCAR-AIO for the Treatment of Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE)

Overview

This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory systemic lupus erythematosus.

Detailed description

This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LCAR-AIO, a chimeric antigen receptor (CAR) -T cell therapy in subjects with relapsed/refractory systemic lupus erythematosus. Patients who meet the eligibility criteria will receive LCAR-AIO infusion. The study will include the following sequential stages: screening, apheresis, pre-treatment (cell product preparation: lymphodepleting chemotherapy), treatment (LCAR AIO infusion) and follow-up.

Interventions

  • Biological LCAR-AIO T cells
    Before treatment with LCAR-AIO T cells, subjects will receive a conditioning regimen.

Primary outcome measures

  • Incidence, severity, and type of treatment-emergent adverse events (TEAEs) [Time frame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)]
  • Incidence of dose-limiting toxicity (DLT) [Time frame: 30 days after LCAR-AIO infusion (Day 1)]
  • Pharmacokinetics in peripheral blood [Time frame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)]
  • Recommended Phase 2 Dose (RP2D) regimen finding [Time frame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)]
Secondary outcome measures (5)
  • Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline up to 104 weeks [Time frame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)]
  • Change in Physician global assessment (PGA) scores from baseline up to 104 weeks [Time frame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)]
  • Lupus Low Disease Activity State (LLDAS) response rates at multiple visits post-infusion [Time frame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)]
  • 24h urinary protein/urine protein-to-creatinine ratio (UPCR) changes from baseline up to 104 weeks [Time frame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)]
  • Changes from baseline in immunological markers and Immunogenicity (anti-drug antibody) [Time frame: Time Frame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)]

Eligibility criteria

  • Subjects voluntarily participate in clinical research.
  • Age 18-65 years.
  • Have been diagnosed of SLE at least 6 months before screening.
  • At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Sm antibody should be positive.
  • Fulfill relapsed/refractory SLE conditions.
  • Adequate organ function at screening.
  • Clinical laboratory values meet criteria at screening.

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, or planning to become pregnant while participating in this study or within 1 year of receiving LCAR-AIO treatment.
  • Participated in other clinical trials within

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
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Wuhan Union Hospital — Wuhan

Identifiers

NCT: NCT06653556 · LB2305-0001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗