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A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Immune Nephritis

NCT ID: NCT05085418

Last Updated: 2021-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-05

Study Completion Date

2024-11-05

Brief Summary

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A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Immune Nephritis

Detailed Description

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Immune nephritis is a chronic glomerular disease originating in the kidney caused by various etiologies.Clinically, secondary chronic kidney damage caused by systemic diseases such as diabetes, systemic lupus erythematosus and gout is named after its primary disease, such as diabetic nephropathy and lupus nephritis. Autoimmune diseases only show local pathological damage, but more often systemic lesions. If not diagnosed and treated in time or poorly controlled, a risk of disability or even death as the course of the disease progresses. Studies have shown that B cells can present their own antigens to autoimmune T cells to promote the release of inflammatory factors, or they can differentiate into plasma cells to release autoantibodies, and play an important role in the occurrence and progression of autoimmune diseases. In recent years, it has become a major research focus to deplete B cells in patients or inhibit B cell function. This research focuses on CAR-T cells killing B cells.

Based on the current research progress, our center intends to conduct research on the safety and effectiveness of CD19/BCMA CAR-T cells in the treatment of refractory systemic lupus erythematosus.

Conditions

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Immune Nephritis Autoimmune Diseases Lupus Nephritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment of Immune Nephritis

Administration of CD19/BCMA CAR T-cells A dose levels of 1-4\*10E6/kg are administrated for each subject.

Group Type EXPERIMENTAL

Assigned Interventions CD19/BCMA CAR T-cells

Intervention Type BIOLOGICAL

Drug: CD19/BCMA CAR T-cells Each subject receive CD19/BCMA CAR T-cells by intravenous infusion Other Name: CD19/BCMA CAR T-cells injection

Interventions

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Assigned Interventions CD19/BCMA CAR T-cells

Drug: CD19/BCMA CAR T-cells Each subject receive CD19/BCMA CAR T-cells by intravenous infusion Other Name: CD19/BCMA CAR T-cells injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 1\. Immune Nephritis with positive CD19/BCMA expression , and the conventional treatment is not effective and (or) no effective treatment 2. Estimated survival time\> 12 weeks; 3. Patients had a negative urine pregnancy test before the start of administration and agreed to take effective contraceptive measures during the test period until the last follow-up; 4. Patients or their legal guardians volunteer to participate in the study 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. Pregnant (or lactating) women;
4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
5. Active infection of hepatitis B virus or hepatitis C virus;
6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
7. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
8. Other uncontrolled diseases that were not suitable for this trial;
9. Patients with HIV infection;
10. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study
11. Platelets ≥30×10E9/L, and absolute lymphocyte count ≥1.0×10E9/L
12. Methylprednisolone (maximum dose 1mg/kg) or prednisone (maximum dose 1.25mg/kg) instead of immunosuppressive agents to control the disease.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yake Biotechnology Ltd.

INDUSTRY

Sponsor Role collaborator

Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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He Huang

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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He Huang, PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

Locations

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The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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He Huang, PhD

Role: CONTACT

[email protected]
86-13605714822

Yongxian Hu, PhD

Role: CONTACT

[email protected]
86-15957162012

Facility Contacts

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He Huang, PhD

Role: primary

[email protected]
86-13605714822

Yongxian Hu, PhD

Role: backup

[email protected]
86-15957162012

Other Identifiers

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CD19/BCMA-004

Identifier Type: -

Identifier Source: org_study_id