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

Clinical Study of Targeting CD19-BAFF CAR-T Cells in the Treatment of Autoimmune Diseases

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

Study Overview

• Status: Recruiting
• Conditions: Autoimmune Diseases
• Intervention / Treatment: Biological: CD19-BAFF Targeted CAR T-cells

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 Type: Interventional
• Enrollment (Estimated): 45
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Yongxian Hu, MD; Phone Number: 86-15957162012; Email: huyongxian2000@aliyun.com
• Study Contact Backup: Name: He Huang, MD; Phone Number: 86-13605714822; Email: hehuangyu@126.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The first affiliated hospital of medical college of zhejiang university
      • Contact: Yongxian Hu, MD; Phone Number: +8615957162012; Email: huyongxian2000@aliyun.com
      • Contact: He Huang, MD; Phone Number: 86-13605714822; Email: hehuangyu@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: CD19-BAFF Targeted CAR T-cells; Each subject receive CD19-BAFF Targeted CAR T-cells by intravenous infusion; Other Names: CD19-BAFF Targeted CAR T-cells injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zhejiang University
• Collaborators: Shanghai YaKe Biotechnology Ltd.
• Investigators: Principal Investigator: He Huang, MD, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: CD19-BAFF CAR-T
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases
• Other Study ID Numbers: TXB2023023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No