CAR-pNK Cell Immunotherapy for Relapsed/Refractory CD33+ AML
NCT ID: NCT02944162
Last Updated: 2016-12-06
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
2016-10-31
2018-09-30
Brief Summary
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Detailed Description
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Determine the safety and feasibility of the chimeric antigen receptor NK92 cells transduced with the anti-CD33 vector (referred to as anti-CD33 CAR-NK cells).
SECONDARY OBJECTIVES:
I. For patients with detectable disease, measure anti-leukemia response due to anti-CD33 CAR-NK cell infusions.
II. For patients with stored or accessible leukemia blasts, determine leukemia cell killing by anti-CD33 CAR-NK in vitro.
III. Determine if cellular or humoral host immunity develops against the murine anti-CD33.
OUTLINE: Patients are assigned to 1 group according to order of enrollment.
Patients receive anti-CD33 CAR-NK (coupled with CD28, CD137 and CD3 zeta signalling domains) vector-transduced NK92 cell line on days 0,3, and 5 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 10 years.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CAR-NK Cell immunotherapy
Enrolled patients will receive CAR-NK cells immunotherapy with a novel specific chimeric antigen receptor targeting CD33 antigen by infusion.
anti-CD33 CAR-NK cells
The allogeneic NK cells (NK-92 cell line for clinical use) are engineered to contain anti-CD33 attached to TCRzeta, CD28 and 4-1BB signaling domains. These modified cells are called chimeric antigen receptor NK cells with specificity for CD33.
Interventions
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anti-CD33 CAR-NK cells
The allogeneic NK cells (NK-92 cell line for clinical use) are engineered to contain anti-CD33 attached to TCRzeta, CD28 and 4-1BB signaling domains. These modified cells are called chimeric antigen receptor NK cells with specificity for CD33.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. CD33+ acute myeloid leukemia CR (complete remission) can not be achieved after at least 2 prior combination chemotherapy regimens.
3. AML in CR2 or CR3 and not eligible for allogeneic SCT because of age, comorbid disease, or lack of available family member or unrelated donor.
4. Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \< 1 year).
5. Relapsed after prior autologous or allogenic SCT. AML patients with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic SCT.
6. Residual disease after primary therapy and not eligible for autologous SCT.
7. All of those patients must also meet the following criteria:
Expected survival \> 12 weeks. Creatinine \< 2.5 mg/dl ALT(alanine aminotransferase)/AST (aspartate aminotransferase)\< 3x normal Bilirubin \< 2.0 mg/dl Any relapse after prior SCT will make patient eligible regardless of other prior therapy.
Adequate venous access for apheresis, and no other contraindications for leukapheresis.
Ability to give informed consent.
Exclusion Criteria
2. Active HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at the time of screening.
3. Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders.
4. History of severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or aldesleukin.
5. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
6. The existence of unstable or active ulcers or gastrointestinal bleeding.
7. Patients need anticoagulant therapy (such as warfarin or heparin).
8. Patients need long-term antiplatelet therapy (aspirin at a dose \> 300mg/d; clopidogrel at a dose \> 75mg/d).
3 Years
80 Years
ALL
No
Sponsors
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The First People's Hospital of Hefei
OTHER
Hefei Binhu Hospital
OTHER
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Lin Yang, Ph.D
Role: primary
References
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Del Zotto G, Marcenaro E, Vacca P, Sivori S, Pende D, Della Chiesa M, Moretta F, Ingegnere T, Mingari MC, Moretta A, Moretta L. Markers and function of human NK cells in normal and pathological conditions. Cytometry B Clin Cytom. 2017 Mar;92(2):100-114. doi: 10.1002/cyto.b.21508. Epub 2017 Feb 12.
Other Identifiers
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PG-0332
Identifier Type: -
Identifier Source: org_study_id