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

NCT06279923 | Recruiting Early Phase 1

• 1 other identifier: TXB2023023
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Autoimmune Diseases

Keywords

CD19-BAFF 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 (3)

• Multiple Myeloma (MM), Overall response rate (ORR)

  Up to 2 years after Treatment

• Progression-free survival (PFS)

  Up to 2 years after Treatment

• Duration of remission,DOR

  Up to 1 years after Treatment

Study Arms (1)

Administration of CD19-BAFF Targeted CAR T-cells

EXPERIMENTAL

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

Biological: CD19-BAFF Targeted CAR T-cells

Interventions

CD19-BAFF Targeted CAR T-cells BIOLOGICAL

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

Also known as: CD19-BAFF Targeted CAR T-cells injection

Administration of CD19-BAFF Targeted CAR T-cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Gender unlimited，18\<Age;
• \. 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
• \. Estimated life expectancy of minimum of 12 weeks;
• \. The blood routine meets the following standards:
• Lymphocyte count\>0.3×10e9/L;
• Neutrophils ≥0.5×10e9/L;
• Hemoglobin ≥60g/L;
• Platelet ≥30×10e9/L
• \. 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;
• Those who voluntarily participated in this trial and provided 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;
• Pregnant or lactating women (the safety of this therapy for unborn children is still unknown)
• \. Patients with HIV infection
• \. Active infection of hepatitis B virus or hepatitis C virus;
• \. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
• \. Creatinine\>176.8 umol/L, or ALT / AST \> 3 times of normal amounts, or bilirubin\>51 umol/L;
• \. Any unsuitable to participate in this trial judged by the investigator;
• \. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene modified cell therapy product within 3 months;
• \. Received immunosuppressive therapy within one week prior to mononuclear cell collection；
• \. 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)；
• \. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.

Sponsors & Collaborators

• Zhejiang University: lead
• Yake Biotechnology Ltd.: collaborator

Study Sites (1)

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• He Huang, MD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

He Huang, MD

CONTACT

86-13605714822; hehuangyu@126.com

Yongxian Hu, MD

CONTACT

86-15957162012; huyongxian2000@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: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 28, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

CN (1)