NCT06653556

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P50-P75 for early_phase_1

Timeline
42mo left

Started Jan 2025

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

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 Progress28%
Jan 2025Sep 2029

First Submitted

Initial submission to the registry

October 11, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

January 8, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

2.7 years

First QC Date

October 11, 2024

Last Update Submit

January 8, 2025

Conditions

Systemic Lupus Erythematosus (SLE)

Keywords

Refractory pulmonary Hypertension (PAH)Recurrent/refractory autoimmune hemolytic anemia (r/r AIHA)Recurrent/refractory lupus nephritis (r/r LN)

Outcome Measures

Primary Outcomes (4)

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

    An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.

    Minimum 104 Weeks after LCAR-AIO infusion (Day 1)

  • Incidence of dose-limiting toxicity (DLT)

    DLTs are severe adverse events 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.

    30 days after LCAR-AIO infusion (Day 1)

  • Pharmacokinetics in peripheral blood

    CAR positive T cells levels in peripheral blood after LCAR-AIO infusion.

    Minimum 104 Weeks after LCAR-AIO infusion (Day 1)

  • Recommended Phase 2 Dose (RP2D) regimen finding

    RP2D established through dose exploratory.

    Minimum 104 Weeks after LCAR-AIO infusion (Day 1)

Secondary Outcomes (5)

  • Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline up to 104 weeks

    Minimum 104 Weeks after LCAR-AIO infusion (Day 1)

  • Change in Physician global assessment (PGA) scores from baseline up to 104 weeks

    Minimum 104 Weeks after LCAR-AIO infusion (Day 1)

  • Lupus Low Disease Activity State (LLDAS) response rates at multiple visits post-infusion

    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

    Minimum 104 Weeks after LCAR-AIO infusion (Day 1)

  • Changes from baseline in immunological markers and Immunogenicity (anti-drug antibody)

    Time Frame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)

Study Arms (1)

LCAR-AIO T Cells

EXPERIMENTAL

Experimental: Chimeric antigen receptor T cells (LCAR-AIO) Each subject will be given a single-dose LCAR-AIO cells infusion at each dose level

Biological: LCAR-AIO T cells

Interventions

LCAR-AIO T cellsBIOLOGICAL

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

LCAR-AIO T Cells

Eligibility Criteria

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

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, 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, SystemicHypertension, PulmonaryRecurrenceAnemia, Hemolytic, AutoimmuneLupus Nephritis

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesLung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesGlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Qiubai Li, Professor

CONTACT

85726808qiubaili@hust.edu.cn

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 11, 2024

First Posted

October 22, 2024

Study Start

January 8, 2025

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2029

Last Updated

January 10, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)