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History of Changes for Study: NCT05085444
A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma
Latest version (submitted October 11, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 11, 2021 None (earliest Version on record)
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Study NCT05085444
Submitted Date:  October 11, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: CD19/BCMA-002
Brief Title: A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma
Official Title: A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2021
Overall Status: Recruiting
Study Start: October 8, 2021
Primary Completion: October 8, 2024 [Anticipated]
Study Completion: October 8, 2024 [Anticipated]
First Submitted: October 11, 2021
First Submitted that
Met QC Criteria:
October 11, 2021
First Posted: October 20, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
October 11, 2021
Last Update Posted: October 20, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Zhejiang University
Responsible Party: Principal Investigator
Investigator: He Huang
Official Title: Clinical Professor
Affiliation: Zhejiang University
Collaborators: Yake Biotechnology Ltd.
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma
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

Open or close this module Conditions
Conditions: Scleroderma
Autoimmune Diseases
Keywords: Scleroderma
CD19 CAR T-cell therapy
BCMA CAR T-cell therapy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Early Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 9 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age:
Maximum Age:
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: He Huang, PhD
Telephone: 86-13605714822
Email: hehuangyu@126.com
Central Contact Backup: Yongxian Hu, PhD
Telephone: 86-15957162012
Email: huyongxian2000@aliyun.com
Study Officials: He Huang, PhD
Principal Investigator
First Affiliated Hospital of Zhejiang University
Locations: China, Zhejiang
The First Affiliated Hospital, College of Medicine, Zhejiang University
[Recruiting]
Hangzhou, Zhejiang, China, 310003
Contact:Contact: He Huang, PhD 86-13605714822 hehuangyu@126.com
Contact:Contact: Yongxian Hu, PhD 86-15957162012 huyongxian2000@aliyun.com
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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