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A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05085444
Recruitment Status : Recruiting
First Posted : October 20, 2021
Last Update Posted : October 20, 2021
Sponsor:
Collaborator:
Yake Biotechnology Ltd.
Information provided by (Responsible Party):
He Huang, Zhejiang University

Study Description
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Brief Summary:
A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma

Condition or disease Intervention/treatment Phase
Scleroderma Autoimmune Diseases Biological: Assigned Interventions CD19/BCMA CAR T-cells Early Phase 1

Detailed Description:

Autoimmune diseases only show local pathological damage, but more often systemic lesions. If not diagnosed and treated in time or poorly controlled, a risk of disability or even death as the course of the disease progresses. Studies have shown that B cells can present their own antigens to autoimmune T cells to promote the release of inflammatory factors, or they can differentiate into plasma cells to release autoantibodies, and play an important role in the occurrence and progression of autoimmune diseases. In recent years, it has become a major research focus to deplete B cells in patients or inhibit B cell function. This research focuses on CAR-T cells killing B cells. This fully reflects the application prospects of CAR-T cells in autoimmune diseases.

Based on the current research progress, our center intends to conduct research on the safety and effectiveness of CD19/BCMA CAR-T cells in the treatment of refractory scleroderma

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma
Actual Study Start Date : October 8, 2021
Estimated Primary Completion Date : October 8, 2024
Estimated Study Completion Date : October 8, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment of Scleroderma
Experimental：Administration of CD19/BCMA CAR T-cells A dose levels of 1-4*10E6/kg are administrated for each subject.
 Biological: Assigned Interventions CD19/BCMA CAR T-cells
Drug: CD19/BCMA CAR T-cells Each subject receive CD19/BCMA CAR T-cells by intravenous infusion Other Name: CD19/BCMA CAR T-cells injection


Outcome Measures
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Primary Outcome Measures :
  1. Dose-limiting toxicity (DLT) [ Time Frame: Baseline up to 28 days after CD19/BCMA CAR T-cells infusion ]
    Adverse events assessed according to NCI-CTCAE v5.0 criteria

  2. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 90 days after CD19/BCMA CAR T-cells infusion ]
    Incidence of treatment-emergent adverse events [Safety and Tolerability]


Secondary Outcome Measures :
  1. Concentration of CAR-T cells [ Time Frame: From admission to the end of the follow-up, up to 2 years ]
    In peripheral blood

  2. Objective Response Rate, ORR [ Time Frame: In 3 months of CD19/BCMA CAR-T cell infusion ]
    Proportion of subjects with complete or partial remission

  3. Disease control rate, DCR [ Time Frame: From Day 28 CD19/BCMA CAR-T infusion up to 2 years ]
    The percentage of patients with remission and stable disease after treatment in the total evaluable cases.

  4. Duration of remission, DOR [ Time Frame: 24 months post CD19/BCMA CAR-T cells infusion ]
    The time from the first assessment of remission or partial remission of the disease to the first assessment of disease progression or death from any cause

  5. Progression-free survival, PFS [ Time Frame: 24 months post CD19/BCMA CAR-Tcells infusion ]
    The time from cell reinfusion to the first assessment of disease progression or death from any cause

  6. Overall survival, OS [ Time Frame: From CD19/BCMA CAR-T infusion to death，up to 2 years ]
    The time from the cell reinfusion to death due to any cause


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Scleroderma with positive CD19/BCMA expression , and the conventional treatment is not effective and (or) no effective treatment
  2. Estimated survival time> 12 weeks;
  3. Patients had a negative urine pregnancy test before the start of administration and agreed to take effective contraceptive measures during the test period until the last follow-up;
  4. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

Exclusion Criteria:

  • Subjects with any of the following exclusion criteria were not eligible for this trial:

    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;
    4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
    5. Active infection of hepatitis B virus or hepatitis C virus;
    6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
    7. Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
    8. Other uncontrolled diseases that were not suitable for this trial;
    9. Patients with HIV infection;
    10. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study
    11. Platelets ≥30×10E9/L, and absolute lymphocyte count ≥1.0×10E9/L
    12. Methylprednisolone (maximum dose 1mg/kg) or prednisone (maximum dose 1.25mg/kg) instead of immunosuppressive agents to control the disease.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05085444


Contacts
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Contact: He Huang, PhD 86-13605714822 hehuangyu@126.com
Contact: Yongxian Hu, PhD 86-15957162012 huyongxian2000@aliyun.com

Locations
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China, Zhejiang
The First Affiliated Hospital, College of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: He Huang, PhD    86-13605714822    hehuangyu@126.com   
Contact: Yongxian Hu, PhD    86-15957162012    huyongxian2000@aliyun.com   
Sponsors and Collaborators
Zhejiang University
Yake Biotechnology Ltd.
Investigators
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Principal Investigator: He Huang, PhD First Affiliated Hospital of Zhejiang University
More Information
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Responsible Party: He Huang, Clinical Professor, Zhejiang University
ClinicalTrials.gov Identifier: NCT05085444    
Other Study ID Numbers: CD19/BCMA-002
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by He Huang, Zhejiang University:
Scleroderma
CD19 CAR T-cell therapy
BCMA CAR T-cell therapy
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Autoimmune Diseases
 Connective Tissue Diseases
Skin Diseases
Immune System Diseases