CD19-BAFF CAR-T Cells Therapy for Patients With Autoimmune Diseases

NCT ID: NCT06279923

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2027-02-01

Brief Summary

Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for Autoimmune Diseases.

Detailed Description

In this study, 45 patients with Autoimmune Diseases include Systemic Lupus Erythematosus、Systemic sclerosis、Dermatomyositis、Immune nephritis and Neuromyelitis optica were proposed to undergo CD19-BAFF CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19-BAFF CAR-T cell therapy for Autoimmune Diseases; At the same time, on the basis of expanding the sample size, more safety data on CD19-BAFF CAR-T cell treatment for Autoimmune Diseases were accumulated, including rare and delayed complications.

Conditions

Autoimmune Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Administration of CD19-BAFF Targeted CAR T-cells

Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.

Group Type: EXPERIMENTAL

CD19-BAFF Targeted CAR T-cells

Intervention Type: BIOLOGICAL

Each subject receive CD19-BAFF Targeted CAR T-cells by intravenous infusion

Interventions

CD19-BAFF Targeted CAR T-cells

Each subject receive CD19-BAFF Targeted CAR T-cells by intravenous infusion

Intervention Type: BIOLOGICAL

Other Intervention Names

CD19-BAFF Targeted CAR T-cells injection

Eligibility Criteria

Inclusion Criteria

• 1. Gender unlimited，18<Age;
• 2. Diagnosed as Autoimmune Diseases（Systemic Lupus Erythematosus，Immune nephritis, Systemic sclerosis，Dermatomyositis，Neuromyelitis optica）and after routine treatment (using more than 2 types drugs, such as hormones and Immunosuppressants，Immunomodulator or Biological agents) are ineffective for more than 6 months or reappear with disease activity and/or no effective treatment after disease remission
• 3. Estimated life expectancy of minimum of 12 weeks;
• 4. The blood routine meets the following standards:

1. Lymphocyte count>0.3×10e9/L;

2. Neutrophils ≥0.5×10e9/L;

3. Hemoglobin ≥60g/L;

4. Platelet ≥30×10e9/L

• 5. Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;
• 6.Those who voluntarily participated in this trial and provided 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 (the safety of this therapy for unborn children is still unknown)
• 4. Patients with HIV infection
• 5. Active infection of hepatitis B virus or hepatitis C virus;
• 6. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
• 7. Creatinine>176.8 umol/L, or ALT / AST > 3 times of normal amounts, or bilirubin>51 umol/L;
• 8. Any unsuitable to participate in this trial judged by the investigator;
• 9. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene modified cell therapy product within 3 months;
• 10. Received immunosuppressive therapy within one week prior to mononuclear cell collection；
• 11. ndividuals who have used systemic steroid drugs exceeding 20mg/d of prednisone or equivalent doses within one week prior to treatment (excluding those who have recently or are currently using inhaled steroids)；
• 12. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yake Biotechnology Ltd.

INDUSTRY

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

He Huang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

He Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Locations

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

He Huang, MD

Role: CONTACT

hehuangyu@126.com

86-13605714822

Yongxian Hu, MD

Role: CONTACT

huyongxian2000@aliyun.com

86-15957162012

Facility Contacts

He Huang, MD

Role: primary

hehuangyu@126.com

86-13605714822

Yongxian Hu, MD

Role: backup

huyongxian2000@aliyun.com

+8615957162012

Other Identifiers

TXB2023023

Identifier Type: -

Identifier Source: org_study_id