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CAR-pNK Cell Immunotherapy for Relapsed/Refractory CD33+ AML

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02944162
Recruitment Status : Unknown
Verified October 2016 by PersonGen BioTherapeutics (Suzhou) Co., Ltd..
Recruitment status was:  Recruiting
First Posted : October 25, 2016
Last Update Posted : December 6, 2016
Sponsor:
Collaborators:
The First People's Hospital of Hefei
Hefei Binhu Hospital
Information provided by (Responsible Party):
PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Study Description
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Brief Summary:
The purpose of this clinical trial is to study genetically engineered NK92 cell therapy in treating patients with CD33 positive acute myeloid leukemias that is relapsed (after stem cell transplantation or intensive chemotherapy) or refractory to further chemotherapy.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Acute Myeloid Leukemia Acute Myeloid Leukemia With Maturation Acute Myeloid Leukemia Without Maturation ANLL Biological: anti-CD33 CAR-NK cells Phase 1 Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Investigation of Chimeric CD(Cluster of Differentiation)33 Antigen Receptor-modified NK92 Cells in Relapsed and/or Refractory Acute Myeloid Leukemias
Study Start Date : October 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CAR-NK Cell immunotherapy
Enrolled patients will receive CAR-NK cells immunotherapy with a novel specific chimeric antigen receptor targeting CD33 antigen by infusion.
 Biological: 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 Name: Chimeric antigen receptor NK92 cells with specificity for CD33


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events attributed to the administration of the anti-CD33 CAR-NK cells [ Time Frame: One year ]
    Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment


Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Up to one year ]
    Anti-leukemia responses to anti-CD33 CAR-NK cell infusions


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female subjects with CD33+ acute myeloid leukemia in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (>12 weeks to < 2 year survival) with currently available therapies will be enrolled.
  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:

  1. Pregnant or nursing women may not participate.
  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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944162


Contacts
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Contact: Lin Yang, Ph.D 86-512-65922190 info@persongen.com

Locations
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China, Jiangsu
PersonGen BioTherapeutics (Suzhou) Co., Ltd. Recruiting
Suzhou, Jiangsu, China, 215123
Contact: Lin Yang, Ph.D    86-512-65922190    info@persongen.com   
Principal Investigator: Yangyi Bao, MD         
Principal Investigator: Xiang Sun, MD         
Principal Investigator: Lin Yang, Ph.D         
Sponsors and Collaborators
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
The First People's Hospital of Hefei
Hefei Binhu Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT02944162    
Other Study ID Numbers: PG-0332
First Posted: October 25, 2016    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: (1) The use of a controlled access approach, using a transparent and robust system to review requests and provide secure data access; (2) Seeking consent for sharing IPD from trial participants in all future clinical trials with adequate assurance that patient privacy and confidentiality can be maintained; and (3) Establishing an approach to resource the sharing of IPD which would include support from trial funders, sponsor organisations and users of IPD.
Keywords provided by PersonGen BioTherapeutics (Suzhou) Co., Ltd.:
AML
CD33
CAR-NK
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms