ET190L1-ARTEMIS™ T Cells in Relapsed, Refractory B Cell Leukemia and Lymphoma
NCT ID: NCT03895944
Last Updated: 2019-03-29
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
EARLY_PHASE1
18 participants
INTERVENTIONAL
2017-12-06
2019-12-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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iv low dose
Autologous ET190L1-ARTEMIS™ T cells administered by intravenous (IV) infusion with low dose (1x10\^6) in Leukemia or Lymphoma patients
ET190L1-ARTEMIS™ T cells -iv low dose
Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 1x10\^6
iv middle dose
Autologous ET190L1-ARTEMIS™ T cells administered by intravenous (IV) infusion with middle dose (3x10\^6) in Leukemia or Lymphoma patients
ET190L1-ARTEMIS™ T cells -iv middle dose
Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 3x10\^6
iv high dose
Autologous ET190L1-ARTEMIS™ T cells administered by intravenous (IV) infusion with high dose (10x10\^6) in Leukemia or Lymphoma patients
ET190L1-ARTEMIS™ T cells - iv high dose
Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 10x10\^6
Interventions
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ET190L1-ARTEMIS™ T cells -iv low dose
Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 1x10\^6
ET190L1-ARTEMIS™ T cells -iv middle dose
Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 3x10\^6
ET190L1-ARTEMIS™ T cells - iv high dose
Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 10x10\^6
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2, expected survival time \> 3 months per PIs opinion
* Women of childbearing age should have a negative pregnancy test and agree to use effective contraception during treatment and 1 year after the last dose.
* Peripheral venous access is available and no issues with apheresis for lymphocyte isolation
* serum alanine aminotransferase(ALT)\<200 Unit/L, ALT/Aspartate aminotransferase(AST)\<3 normal range; serum creatinine (Cr)\<2.5mg/dL
* Voluntarily signed informed consent form
Exclusion Criteria
* Unable to perform leukapheresis and iv infusion
* With active infection
* Major organ failure
* Patients with dependence on corticosteroids
* Continuously used glucocorticoids or other immunosuppressive agents within 2 weeks
* T cell deficiency or T cells are difficult to be transduced
* Patients currently receiving other investigational treatments (biotherapy, chemotherapy, or radiotherapy)
18 Years
75 Years
ALL
No
Sponsors
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Eureka Therapeutics Inc.
INDUSTRY
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Responsible Party
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Principal Investigators
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Mei Zhang, PhD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital Xi'an Jiaotong University
Locations
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First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
Countries
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Central Contacts
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Facility Contacts
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Mei Zhang, PhD
Role: primary
Other Identifiers
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XJTU1AF2017LSL-C001
Identifier Type: -
Identifier Source: org_study_id