CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis

January 20, 2025 updated by: He Huang

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, 9 patients with relapsed refractory Lupus Nephritis were proposed to undergo CD19/BCMA CAR-T Cells therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19/BCMA CAR-T Cells therapy for relapsed refractory Lupus Nephritis; At the same time, on the basis of expanding the sample size, more safety data on CD19/BCMA CAR-T Cells treatment for relapsed refractory Lupus Nephritis were accumulated.

Study Type

Interventional

Enrollment (Estimated)

9

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The first affiliated hospital of medical college of zhejiang university
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Age ≥18 years old;
  • 2. 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.
  • 3. SLEDAI-2K ≥8 during screening
  • 4. failure to respond to two or more standard immunosuppressive therapies, or relapse (increased disease activity index and need to adjust drug dose or type);
  • 5. Expected survival >12 weeks;
  • 6. 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);
  • 7. Volunteer to participate in this experiment and sign the informed consent.

Exclusion Criteria:

  • 1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
  • 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
  • 3. Active infected persons who are not cured:
  • 4. Active hepatitis B or C virus infection;
  • 5. 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);
  • 6. Have used any gene therapy products before;
  • 7. Insufficient amplification ability (<5 times) in response to CD3 / CD28 costimulation signals;
  • 8. ALT/AST>3 times the normal amount or bilirubin >2.0 mg/dl;
  • 9. Those who have other uncontrolled diseases that the researcher deems unsuitable for enrollment;
  • 10. HIV-infected people;
  • 11. Any situation that the investigator believes may increase the risk to the subject or interfere with the test results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lupus Nephritis
Administration of CD19/BCMA Lupus Nephritis Targeted CAR T-cells
Biological: CD19/BCMA Lupus Nephritis Targeted CAR T-cells injection
Each subject receive CD19/BCMA Lupus Nephritis Targeted CAR T-cells by intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-limiting toxicity (DLT)
Time Frame: Up to 28 years after Treatment
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Up to 28 years after Treatment
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Up to 2 years after Treatment
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Up to 2 years after Treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary protein index
Time Frame: Up to 24 hours after Treatment
Urinary protein index（24h urinary protein、Urinary protein/creatinine ratio）
Up to 24 hours after Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

He Huang

Collaborators

Yake Biotechnology Ltd.

Investigators

  • Principal Investigator: He Huang, MD, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 31, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 20, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TXB2024012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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