Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Relapsed and Refractory Lymphoma
NCT ID: NCT03468153
Last Updated: 2018-03-20
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/PHASE2
10 participants
INTERVENTIONAL
2018-01-01
2020-01-01
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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CAR-T cell therapy
Patient-derived dual specificity CD19 and CD22 CAR-T
Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy
Patient-derived dual specificity CD19 and CD22 CAR-T Cells
Interventions
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Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy
Patient-derived dual specificity CD19 and CD22 CAR-T Cells
Eligibility Criteria
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Inclusion Criteria
* Recieved more than 2 lines of chemotherapy;
* Not eligible for hematopoietic stem cell transplantation or relapsed after hematopoietic stem cell transplantation;
* Life expectation for more than 3 months;
* ECOG ≥ 2;
* Adequate organ function: EF≥50%; normal ECG; CCR≥40ml/min; ALT and AST ≤ 3 × upper limitation of normal, T-BIL ≤ 2.0mg/dl; PT and APTT \< 2 × upper limitation of normal; SpO2 \> 92%;
* CBC results: Hb ≥ 80g/L, ANC \> 1 × 10E9/L, Plt ≥ 50 × 10E9/L;
* Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion;
* With measurable disease;
* Written informed consent could be acquired;
Exclusion Criteria
* Uncontrolled infection;
* HIV positive ;
* Active HBV or HCV infection;
* Women in pregnancy and lactation;
* Refuse to conception control during treatment and 1 year after CAR-T infusion;
* Uncured malignancies other than non-Hodgkin lymphoma;
* Have participated similar trial for treating relapse/refractory non-Hodgkin lymphoma;
* Inheritated immune deficiancy;
* Severe heart disease.
18 Years
65 Years
ALL
No
Sponsors
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Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
INDUSTRY
Ruijin Hospital
OTHER
Responsible Party
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Zhao Weili
Professor
Locations
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Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Ruijin-CAR-01
Identifier Type: -
Identifier Source: org_study_id
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