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Recruiting NCT07331272

A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)

Phase I Interventional Systemic Lupus Erythematosus (SLE) Idiopathic Inflammatory Myopathies(IIM)

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-G79D T cells.
Who it may be relevant to
Registry conditions: Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathies(IIM). 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 the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)

Overview

This is a prospective, single-arm, open-label and dose-escalation investigator initialed study to evaluate LUCAR-G79D in adult subjects with r/r SLE and r/r IIM.

Detailed description

This is a prospective, single-arm, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LUCAR-G79D, a chimeric antigen receptor (CAR) -T cell therapy in subjects with r/r SLE and r/r IIM. Patients who meet the eligibility criteria will receive LUCAR-G79D infusion. The study will include the following sequential stages: screening, pre-treatment (lymphodepleting chemotherapy), treatment (LUCAR-G79D infusion) and follow-up.

Interventions

  • Biological LUCAR-G79D T cells
    Prior to infusion of the LUCAR-G79D T 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: 2 years after LUCAR-G79D infusion (Day 1)]
  • Incidence of dose-limiting toxicity (DLT) [Time frame: 2 years after LUCAR-G79D infusion (Day 1)]
  • Maximum concentration (Cmax) in peripheral blood [Time frame: 2 years after LUCAR-G79D infusion (Day 1)]
  • Time of maximum concentration (Tmax) in peripheral blood [Time frame: 2 years after LUCAR-G79D infusion (Day 1)]
  • Area under the concentration-time curve (AUC) in peripheral blood [Time frame: 2 years after LUCAR-G79D infusion (Day 1)]
  • Recommended Dose regimen finding [Time frame: 2 years after LUCAR-G79D infusion (Day 1)]
Secondary outcome measures (4)
  • Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline up to 52 weeks for r/r SLE subjects [Time frame: 52 weeks after LUCAR-G79D infusion (Day 1)]
  • Change in manual muscle testing (MMT-8) scores from baseline up to 52 weeks for r/r IIM subjects [Time frame: 52 weeks after LUCAR-G79D infusion (Day 1)]
  • Changes from baseline in peripheral blood immunoglobulins from baseline up to 52 weeks for all subjects [Time frame: 52 weeks after LUCAR-G79D infusion (Day 1)]
  • Changes from baseline in anti-drug antibody from baseline up to 52 weeks for all subjects [Time frame: 52 weeks after LUCAR-G79D infusion (Day 1)]

Eligibility criteria

Inclusion criteria

  • Subjects voluntary agreement to provide written informed consent.
  • Aged 18 to 70 years, either sex.
  • Adequate organ function meet screening criteria.
  • Positive test for cluster of differentiation antigen 19 (CD19).

SLE:

  • Have been diagnosed of SLE at least 6 months before screening.
  • At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smith antibody should be positive.
  • Fulfill relapsed/refractory SLE conditions.

IIM:

  • Have been diagnosed of IIM before screening.
  • Positive test for myositis-associated antibodies or myositis-specific antibodies at screening.
  • Fulfill relapsed/refractory IIM 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.

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 · 5 centers
  • The Third The People's Hospital of Bengbu — Bengbu
  • Nanfang Hospital — Guangzhou
  • Xiangya Hospital of Central South University — Changsha
  • The Affiliated Hospital of Xuzhou Medical University — Xuzhou
  • The First Affiliated Hospital of Nanchang University — Nanchang

Identifiers

NCT: NCT07331272 · LB2404D-0001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗