A Study of Anti-CD19 CAR-T Cell Immunotherapy for Refractory /Relapsed B Cell Malignancies
NCT ID: NCT03191773
Last Updated: 2017-06-20
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
100 participants
INTERVENTIONAL
2017-06-30
2020-12-31
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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Anti-CD19 CAR transduced T cells
Patients will receive a lymphodepleting preconditioning regimen with Fludarabine and Cyclophosphamide followed by anti-CD19 CAR-transduced T cells.
Drugs and anti-CD19 CAR transduced T cells
Drug: Fludarabine On days -4 through -2, Fludarabine 30mg/m2 (IV) will be infused over 30 minutes.
Drug: Cyclophosphamide On days -4 through -2, Cyclophosphamide 300-500mg/m2 IV will be infused over 60 minutes followed by fludarabine.
Biological: Anti-CD19-CAR T cells On day 0, cells will be infused intravenously IV over 20 - 30 minutes.
Interventions
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Drugs and anti-CD19 CAR transduced T cells
Drug: Fludarabine On days -4 through -2, Fludarabine 30mg/m2 (IV) will be infused over 30 minutes.
Drug: Cyclophosphamide On days -4 through -2, Cyclophosphamide 300-500mg/m2 IV will be infused over 60 minutes followed by fludarabine.
Biological: Anti-CD19-CAR T cells On day 0, cells will be infused intravenously IV over 20 - 30 minutes.
Eligibility Criteria
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Inclusion Criteria
2. Patients must have a measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis；
3. Patients with history of allogeneic stem cell transplantation are eligible, providing 6 months had elapsed from SCT, they have no evidence of active graft-versus-host disease (GVHD) and no longer taking immunosuppressive agents during the treatment;
4. Able to understand and sign the Informed Consent Document；
5. There is no obvious dysfunctions in heart , liver, lung, kidney, and performance status with ECOG \< 2；
6. Life expectancy：More than 3 months for leukemia and more than 6 months for lymphoma.
Exclusion Criteria
2. Patients that have active hemolytic anemia；
3. Patients who have uncontrollable infectious diseases within 2 weeks before enrollment;
4. Patients with human immunodeficiency virus (HIV) antibody seropositive;
5. Active infection of Hepatitis B virus and / or hepatitis C virus;
6. Patients with any residual intracranial implants；
7. Coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system；
8. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease)；
9. Concurrent opportunistic infections；
10. Concurrent systemic steroid therapy；
11. History of severe immediate hypersensitivity reaction to any of the agents used in this study；
12. Women of child-bearing potential who are pregnant or breastfeeding；
13. Patients with cardiac atrial or cardiac ventricular lymphoma involvement；
14. Other anti-neoplastic investigational agents currently or within 30 days prior to start of the treatment；
15. Psychiatric patients;
16. Previous treatment with any gene therapy products.
14 Years
80 Years
ALL
No
Sponsors
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Shenzhen Institute for Innovation and Translational Medicine
OTHER
Guangzhou First People's Hospital
OTHER
First People's Hospital of Foshan
OTHER
Dongguan People's Hospital
OTHER_GOV
The First Affiliated Hospital of Guangdong Pharmaceutical University
OTHER
Second Affiliated Hospital of Guangzhou Medical University
OTHER
Responsible Party
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Principal Investigators
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Ying Feng, MD
Role: STUDY_DIRECTOR
Second Affiliated Hospital of Guangzhou Medical University
Mingjun Wang, MD
Role: STUDY_DIRECTOR
Shenzhen Institute for Innovation and Translational Medicine
Locations
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Department of Hematology, Dongguan People's Hospital
Dongguan, Guangdong, China
Department of Hematology, the First People's Hospital of Foshan
Foshan, Guangdong, China
Department of Hematology, Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Department of Hematology, The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
Department of Hematology,the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2017-HS-32
Identifier Type: -
Identifier Source: org_study_id
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