CD19/20 Bispecific Nanobody-derived CAR-T Cells in B Cell Lymphoma
NCT ID: NCT03881761
Last Updated: 2019-03-21
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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UNKNOWN
PHASE1
50 participants
INTERVENTIONAL
2019-02-01
2022-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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experimental arm
CAR-T cell group
CD19/CD20 bispecific CAR-T cells
collecting blood for CAR-T cells culture three days later, FC regimen (fludarabine 30mg/m2/d x 3, cyclophosphamide 600-800mg/m2/d x 2) another two days later, transfusing CD19/CD20 bispecific CAR-T cell with a dose of 1-3x106/kg
Interventions
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CD19/CD20 bispecific CAR-T cells
collecting blood for CAR-T cells culture three days later, FC regimen (fludarabine 30mg/m2/d x 3, cyclophosphamide 600-800mg/m2/d x 2) another two days later, transfusing CD19/CD20 bispecific CAR-T cell with a dose of 1-3x106/kg
Eligibility Criteria
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Inclusion Criteria
* CD19/CD20 positive relapsed/refractory B cell lymphoma
* KPS\>70
* at least one measurable lesion according to RECIST 1.1
* enough function of hear, liver, kidney and bone marrow
* no history of severe allergies
* no other history of malignancy
* no other diseases that conflict with this regimen
* no serious mental illness
* patient or family member sign informed consent
Exclusion Criteria
* Severe infectious or viral disease
* Active B or C viral hepatitis
* Patients who have used large amounts of glucocorticoids or other immunosuppressive agents during the last 4 weeks
* participated in other clinical studies in the last 3 months, or have been treated with other gene products
* Others not appropriate to participate in this study examined by the investigators
17 Years
70 Years
ALL
No
Sponsors
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Henan Hualong Biotechnology Company
UNKNOWN
Henan Cancer Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Yongping Song, Dr.
Role: STUDY_CHAIR
Henan Cancer Hospital
Locations
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Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HenanCH CART 2-3
Identifier Type: -
Identifier Source: org_study_id
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