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

Autoimmune Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06279923
• Other study ID #: TXB2023023
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 15, 2024
• Est. completion date: February 1, 2027

Study information

• Verified date: April 2024
• Source: Zhejiang University
• Contact: He Huang, MD
• Phone: 86-13605714822
• Email: hehuangyu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Autoimmune Diseases

Intervention

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

Locations

Country	Name	City	State
China	The first affiliated hospital of medical college of zhejiang university	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang University	Shanghai YaKe Biotechnology Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity (DLT)	Adverse events assessed according to NCI-CTCAE v5.0 criteria	Up to 28 years after Treatment
Primary	Incidence of treatment-emergent adverse events (TEAEs)	Incidence of treatment-emergent adverse events [Safety and Tolerability]	Up to 2 years after Treatment
Secondary	Multiple Myeloma (MM), Overall response rate (ORR)	Assessment of ORR (ORR = sCR+CR+VGPR+PR+MR)	Up to 2 years after Treatment
Secondary	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
Secondary	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