NCT07331272

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
46mo left

Started Jan 2026

Longer than P75 for phase_1

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jan 2026Jan 2030

First Submitted

Initial submission to the registry

December 15, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

January 29, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2030

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

December 15, 2025

Last Update Submit

January 29, 2026

Conditions

Systemic Lupus Erythematosus (SLE)Idiopathic Inflammatory Myopathies(IIM)

Outcome Measures

Primary Outcomes (6)

  • Incidence, severity, and type of treatment-emergent adverse events (TEAEs)

    2 years after LUCAR-G79D infusion (Day 1)

  • Incidence of dose-limiting toxicity (DLT)

    2 years after LUCAR-G79D infusion (Day 1)

  • Maximum concentration (Cmax) in peripheral blood

    2 years after LUCAR-G79D infusion (Day 1)

  • Time of maximum concentration (Tmax) in peripheral blood

    2 years after LUCAR-G79D infusion (Day 1)

  • Area under the concentration-time curve (AUC) in peripheral blood

    2 years after LUCAR-G79D infusion (Day 1)

  • Recommended Dose regimen finding

    2 years after LUCAR-G79D infusion (Day 1)

Secondary Outcomes (4)

  • Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline up to 52 weeks for r/r SLE subjects

    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

    52 weeks after LUCAR-G79D infusion (Day 1)

  • Changes from baseline in peripheral blood immunoglobulins from baseline up to 52 weeks for all subjects

    52 weeks after LUCAR-G79D infusion (Day 1)

  • Changes from baseline in anti-drug antibody from baseline up to 52 weeks for all subjects

    52 weeks after LUCAR-G79D infusion (Day 1)

Study Arms (1)

Chimeric antigen receptor T cells (LUCAR-G79D)

EXPERIMENTAL

Each subject will be given a single-dose LUCAR-G79D cells infusion at each dose level.

Biological: LUCAR-G79D T cells

Interventions

LUCAR-G79D T cellsBIOLOGICAL

Prior to infusion of the LUCAR-G79D T cells, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.

Chimeric antigen receptor T cells (LUCAR-G79D)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

The Third The People's Hospital of Bengbu

Bengbu, Anhui, China

RECRUITING

Nanfang Hospital

Guangzhou, Guangdong, China

NOT YET RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, China

NOT YET RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

NOT YET RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, SystemicMyositis

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2025

First Posted

January 9, 2026

Study Start

January 29, 2026

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2030

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(5)