NCT06785519

Brief Summary

A Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for early_phase_1

Timeline
18mo left

Started Jan 2025

Typical duration 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 Progress46%
Jan 2025Oct 2027

First Submitted

Initial submission to the registry

January 13, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 21, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

January 31, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

January 21, 2025

Status Verified

October 1, 2024

Enrollment Period

2.7 years

First QC Date

January 13, 2025

Last Update Submit

January 20, 2025

Conditions

Lupus Nephritis

Keywords

CD19/BCMA CAR-T

Outcome Measures

Primary Outcomes (2)

  • Dose-limiting toxicity (DLT)

    Adverse events assessed according to NCI-CTCAE v5.0 criteria

    Up to 28 years after Treatment

  • Incidence of treatment-emergent adverse events (TEAEs)

    Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

    Up to 2 years after Treatment

Secondary Outcomes (1)

  • Urinary protein index

    Up to 24 hours after Treatment

Study Arms (1)

Lupus Nephritis

EXPERIMENTAL

Administration of CD19/BCMA Lupus Nephritis Targeted CAR T-cells

Biological: CD19/BCMA Lupus Nephritis Targeted CAR T-cells injection

Interventions

CD19/BCMA Lupus Nephritis Targeted CAR T-cells injectionBIOLOGICAL

Each subject receive CD19/BCMA Lupus Nephritis Targeted CAR T-cells by intravenous infusion

Lupus Nephritis

Eligibility Criteria

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

You may qualify if:

  • \. Age ≥18 years old;
  • \. A clinical diagnosis of systemic lupus erythematosus (SLE) according to the 2019 American College of Rheumatology (ACR) and European Federation of Rheumatology Societies (EULAR) /ACR classification criteria. Grade III, IV, or V lupus nephritis was confirmed by biopsy according to the 2003 ISN/RPS standard.
  • \. SLEDAI-2K ≥8 during screening
  • \. failure to respond to two or more standard immunosuppressive therapies, or relapse (increased disease activity index and need to adjust drug dose or type);
  • \. Expected survival \>12 weeks;
  • \. Fertile women and men agree to use appropriate contraceptive methods before entering the study, during study participation, and for 6 months after transfusion (the safety of this therapy for the unborn child is not known);
  • \. Volunteer to participate in this experiment and sign the informed consent.

You may not qualify if:

  • \. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
  • \. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
  • \. Active infected persons who are not cured:
  • \. Active hepatitis B or C virus infection;
  • \. Patients who have taken more than 20mg/d of prednisone or equivalent systemic steroid drugs within 1 week prior to treatment (except those who have recently or currently taken inhaled steroids);
  • \. Have used any gene therapy products before;
  • \. Insufficient amplification ability (\<5 times) in response to CD3 / CD28 costimulation signals;
  • \. ALT/AST\>3 times the normal amount or bilirubin \>2.0 mg/dl;
  • \. Those who have other uncontrolled diseases that the researcher deems unsuitable for enrollment;
  • \. HIV-infected people;
  • \. Any situation that the investigator believes may increase the risk to the subject or interfere with the test results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • He Huang, MD

    Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

He Huang, MD

CONTACT

0571-87233772hehuangyu@126.com

Yongxian Hu, MD

CONTACT

0571-87233772huyongxian2000@aliyun.com

Study Design

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

Study Record Dates

First Submitted

January 13, 2025

First Posted

January 21, 2025

Study Start

January 31, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

January 21, 2025

Record last verified: 2024-10

Locations

CN(1)