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

Early Phase 1

Recruiting

• Conditions: Autoimmune Diseases
• Interventions: Biological: CD19-BAFF Targeted CAR T-cells

• Registration Number: NCT06279923
• Lead Sponsor: Zhejiang University

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.

Study Timeline

• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-02-19
• Study First Posted: 2024-02-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-09
• Study Start: 2024-04-15
• Primary Completion: 2027-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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:

  5. Lymphocyte count>0.3×10e9/L;

  6. Neutrophils ≥0.5×10e9/L;

  7. Hemoglobin ≥60g/L;

  8. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Administration of CD19-BAFF Targeted CAR T-cells	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Duration of remission,DOR	Up to 1 years after Treatment	The time from CR/CRi and PR to disease relapsed or death due to disease
Multiple Myeloma (MM), Overall response rate (ORR)	Up to 2 years after Treatment	Assessment of ORR (ORR = sCR+CR+VGPR+PR+MR)
Progression-free survival (PFS)	Up to 2 years after Treatment	The time from randomization or start of study treatment until objective tumor progression or death

Trial Locations

Locations (1)

The first affiliated hospital of medical college of zhejiang university; 🇨🇳 Hangzhou, Zhejiang, China