Cord Blood Derived CAR-T Cells in Refractory/Relapsed B Cell Malignancies
NCT ID: NCT03881774
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
20 participants
INTERVENTIONAL
2019-02-27
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
cord blood derived CAR T cells group
CAR-T cells
collecting cord 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 CAR-T cell with a dose of 0.5-3x106/kg
Interventions
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CAR-T cells
collecting cord 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 CAR-T cell with a dose of 0.5-3x106/kg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients with refractory/relapsed B cell leukemia/lymphoma whose diseases relapse after autologous CAR-T cells or the preparation for autologous CAR-T cells fails
* KPS \>70
* for patients with lymphoma, at least one measurable lesion according to RECIST 1.1
* enough function of heart, liver, kidney and bone marrow
* no history of severy allergy
* no other serious diseases that conflict with this plan
* no other history of malignancy
* no serious mental illness
* patients and their families members agree to participate in this clinical study and sign the Informed Consent Form
Exclusion Criteria
* vevere infectious or viral diseases
* active hepatitis B or C viral hepatitis
* Patients who have used large amounts of glucocorticoids or other immunosuppressive agents within the last 4 weeks
* participated in other clinical studies in the past 3 months or who have been treated with other gene products;
* others that other investigators consider not suitable for this clinical study
4 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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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 2-4
Identifier Type: -
Identifier Source: org_study_id
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