Clinical trial NCT06279923: CD19-BAFF CAR-T Cells Therapy for Patients With Autoimmune Diseases
Official title: Clinical Study of Targeting CD19-BAFF CAR-T Cells in the Treatment of Autoimmune Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Autoimmune Diseases
Keywords: CD19-BAFF CAR-T
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Yake Biotechnology Ltd.
First posted: 2024-02-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: Up to 28 years after Treatment
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Up to 2 years after Treatment
Secondary outcomes:
measure: Multiple Myeloma (MM), Overall response rate (ORR)
timeFrame: Up to 2 years after Treatment
measure: Progression-free survival (PFS)
timeFrame: Up to 2 years after Treatment
measure: Duration of remission,DOR
timeFrame: Up to 1 years after Treatment
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The first affiliated hospital of medical college of zhejiang university
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: He Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: