A Clinical Study of CD19 Targeted CAR-T for Patients With CD19+ Lymphoma and Leukemia
NCT ID: NCT03383952
Last Updated: 2017-12-27
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
20 participants
INTERVENTIONAL
2017-03-01
2025-12-31
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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ICAR19 CAR-T cells
Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 CAR-T cells and the investigators will determine the safety and therapeutic effects of these cells.
ICAR19 CAR-T cells
T cells were isolated from peripheral blood from patients enrolled. T cells were transduced with lentivirus bearing anti-CD19 antibody scFV and the activation signals of second generation CART designation. The CART cells were infused into the patients by IV with an escalating dosage.
Interventions
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ICAR19 CAR-T cells
T cells were isolated from peripheral blood from patients enrolled. T cells were transduced with lentivirus bearing anti-CD19 antibody scFV and the activation signals of second generation CART designation. The CART cells were infused into the patients by IV with an escalating dosage.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* survival\>12 weeks;
* FEV1, FVC and DLCO ≥50% of expected corrected for hemoglobin;
* LVEF≥50%;
* Creatinine\<2.5mg/dl;
* Bilirubin\<2.5mg/dl;
* ALT (alanine aminotransferase)/AST (aspartate aminotransferase)\<3 x normal;
* At least 7 days after last chemotherapy;
* provide with informed consent.
Exclusion Criteria
* Pregnant or breast-feeding women.
* Uncontrolled active infection including hepatitis B or C.
* HIV positive.
* Use of systemic steroids within 72 hours.
* Allogeneic lymphocyte treatments within recent 6 months.
* Any uncontrolled active medical disorder.
2 Years
80 Years
ALL
No
Sponsors
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Weifang People's Hospital
OTHER
Immune Cell, Inc.
INDUSTRY
Responsible Party
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Xiulian Sun
Principal Investigator
Locations
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Weifang People's Hospital
Weifang, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Xiulian Sun, MD.,Ph.D
Role: primary
xuehong Ran, doctor
Role: backup
Other Identifiers
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CD19 Targeted CAR-T
Identifier Type: -
Identifier Source: org_study_id