Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2022-07-31
2026-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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4SCAR T Cell Therapy for autoimmune diseases
4SCAR T cells
Infusion of 4SCAR T cells at 10\^6 cells/kg body weight via IV
Interventions
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4SCAR T cells
Infusion of 4SCAR T cells at 10\^6 cells/kg body weight via IV
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Guilin Hospital of Chinese Traditional and Western Medicine
UNKNOWN
Shenzhen Geno-Immune Medical Institute
OTHER
Responsible Party
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Locations
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Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China
Guilin Hospital of Chinese Traditional and Western Medicine
Guilin, Guangxi, China
Countries
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Central Contacts
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Facility Contacts
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Qiyong Zhu
Role: primary
Other Identifiers
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GIMI-IRB-22010
Identifier Type: -
Identifier Source: org_study_id
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