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Trial record 1 of 1 for:    NCT05459870
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CAR-T Cells Targeting Autoimmune Diseases

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ClinicalTrials.gov Identifier: NCT05459870
Recruitment Status : Recruiting
First Posted : July 15, 2022
Last Update Posted : July 19, 2022
Sponsor:
Collaborator:
Guilin Hospital of Chinese Traditional and Western Medicine
Information provided by (Responsible Party):
Shenzhen Geno-Immune Medical Institute

Study Description
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Brief Summary:
The purpose of this study is to assess the feasibility, safety and efficacy of CAR-T cell therapy in patients with autoimmune disease. Another goal of the study is to learn more about the safety and function of the CAR-T cells and their persistency in autoimmune disease patients.

Condition or disease Intervention/treatment Phase
Autoimmune Diseases Biological: 4SCAR T cells Phase 1 Phase 2

Detailed Description:

Autoimmune disease refers to the disease in which the immune system reacts to the host's own body and causes damage to tissues and organs. At present, the pathogenesis of various autoimmune diseases is still not well understood, but an imbalanced immune tolerance plays a key role in this process.

An ideal therapy to autoimmune disease should eradicate pathogenic autoimmune cells but retain the protective immunity. The chimeric antigen receptor-modified T (CAR-T) cell technology has proven to be highly effective in targeting B cell malignancies, and the treatment-induced B cell and antibody deficiencies have implications for treating autoantibody-related autoimmune diseases. Studies have shown that CAR-T cells targeting B cell surface molecules can kill autoreactive B lymphocytes in pemphigus vulgaris (PV) and systemic lupus erythematosus (SLE) patients. Thus, CAR-T cell technology targeting B cells has potential in treating autoimmune diseases including PV, SLE, autoimmune hemolytic anemia, Sjogren's syndrome etc..

CD19-specific CAR is based on activation of intracellular signalijng domains of T cells by the extracellular single chain variable fragment (scFv) antibody against CD19. The activated CAR-T cells can target and kill B cells. The investigation plans to use genetically modified T cells to express a 4th generation lentiviral anti-CD19 CAR with an inducible caspase 9 self-withdrawal gene (4SCAR) to increase the safety of this specific approach. Besides targeting CD19, specific CARs targeting other B cell surface molecules including BCMA, CD138, and BAFF-R will also be included in the treatment regimen. Based on accumulated experiences, the 4SCAR T cells have shown high safety profile without serious cytokine release syndrome (CRS) or neural toxicities in patients. Through this trial, the safety and long term efficacy of the B cell-specific 4SCAR T cell therapy will be evaluated, providing clinical evidence supporting the application of 4SCAR-T cell technology in the treatment of autoimmune diseases.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CAR-T Cells Targeting B Cell Related Autoimmune Diseases
Estimated Study Start Date : July 31, 2022
Estimated Primary Completion Date : July 31, 2025
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 4SCAR T Cell Therapy for autoimmune diseases Biological: 4SCAR T cells
Infusion of 4SCAR T cells at 10^6 cells/kg body weight via IV


Outcome Measures
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Primary Outcome Measures :
  1. Safety of 4SCAR T cells in patients with autoimmune diseases [ Time Frame: 12 weeks ]
    Safety of 4SCAR T cells in patients with autoimmune diseases using CTCAE 5 standard to evaluate the level of adverse events


Secondary Outcome Measures :
  1. B cell and immunoglobulin suppression activity of 4SCAR T cells in patients with autoimmune diseases [ Time Frame: 1 year ]
    scale of CAR copies (for efficacy)

  2. B cell and immunoglobulin suppression activity of 4SCAR T cells in patients with autoimmune diseases [ Time Frame: 1 year ]
    immunoglobulin levels (for efficacy)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age older than 18 years.
  2. expression of B cell surface molecules.
  3. the KPS score over 80 points, and survival time is more than 3 months.
  4. greater than Hgb 80 g/L.
  5. no contraindications to blood cell collection.

Exclusion Criteria:

  1. accompanied with other active diseases and difficult to assess treatment response.
  2. bacterial, fungal, or viral infection, unable to control.
  3. living with HIV.
  4. active HBV or HCV infection.
  5. pregnant and nursing mothers.
  6. under systemic steroid treatment within a week of the treatment.
  7. prior failed CAR-T treatment.
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): NCT05459870


Contacts
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Contact: Lung-Ji Chang, PhD 86-0755-86725195 c@szgimi.org

Locations
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China, Guangdong
Shenzhen Geno-immune Medical Institute Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Lung-Ji Chang, PhD    86-0755-86725195    c@szgimi.org   
China, Guangxi
Guilin Hospital of Chinese Traditional and Western Medicine Recruiting
Guilin, Guangxi, China, 541000
Contact: Qiyong Zhu         
Sponsors and Collaborators
Shenzhen Geno-Immune Medical Institute
Guilin Hospital of Chinese Traditional and Western Medicine
More Information
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Responsible Party: Shenzhen Geno-Immune Medical Institute
ClinicalTrials.gov Identifier: NCT05459870    
Other Study ID Numbers: GIMI-IRB-22010
First Posted: July 15, 2022    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Shenzhen Geno-Immune Medical Institute:
CAR-T
autoimmune disease
autoantibody
CD19
 BCMA
CD138
BAFF-R
Additional relevant MeSH terms:
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Autoimmune Diseases
Immune System Diseases