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PCAR-119 Bridge Immunotherapy Prior to Stem Cell Transplant in Treating Patients With CD19 Positive Leukemia and Lymphoma

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: NCT02892695
Recruitment Status : Unknown
Verified December 2016 by PersonGen BioTherapeutics (Suzhou) Co., Ltd..
Recruitment status was:  Recruiting
First Posted : September 8, 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 study is to evaluate the safety and optimal dose of PCAR-119 in patients who are going to receive stem cell transplantation but without available treatment to achieve complete remission prior to the transplant.

Condition or disease Intervention/treatment Phase
Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia Follicular Lymphoma Mantle Cell Lymphoma B-cell Prolymphocytic Leukemia Diffuse Large Cell Lymphoma Biological: anti-CD19 CAR-NK cells Phase 1 Phase 2

Detailed Description:
The purpose of this study is to evaluate the safety and optimal dose of PCAR-119 in patients who are going to receive stem cell transplantation but without available treatment to achieve complete remission prior to the transplant. In addition, some patients who enroll to other CD19-CAR-T cell therapy trials might be eligible for this trial if their CD19-CAR-T cells cannot be produced successfully because they have insufficient T cells to allow the CD19-CAR-T cells to be made; their T cells are inefficiently transduced with CAR viruses; or their CAR-T cell expansion is failed.
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: PCAR-119 Bridge Immunotherapy Prior to Stem Cell Transplant in Treating Patients With CD19 Positive Relapsed or Refractory Leukemia and Lymphoma
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: CAR-NK Cell immunotherapy
Enrolled patients will receive CAR-NK cell immunotherapy with a novel specific chimeric antigen receptor targeting CD19 antigen by infusion.
 Biological: anti-CD19 CAR-NK cells
The allogeneic NK cells (NK-92 cell line for clinical use) are engineered to contain anti-CD19 attached to TCRzeta, CD28 and 4-1BB signaling domains. These modified cells are called chimeric antigen receptor NK cells with specificity for CD19.
Other Name: chimeric antigen receptor NK cells with specificity for CD19


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events attributed to the administration of the anti-CD19 CAR-NK cells [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Safety follow-up is 100 days from last CAR-NK infusion ]

Eligibility Criteria
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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:

Male and female subjects with CD19+ B cell malignancies in patients who have no available curative treatment options except stem cell transplantation, with limited prognosis (several months to < 2 year survival) and no available treatment option to achieve complete remission prior to transplant. Some patients who have enrolled to other CD19-CAR-T cell therapy trials may be eligible if their CD19-CAR-T cells cannot be produced successfully because they have insufficient T cells to allow the CD19-CAR-T cells to be made; their T cells are inefficiently transduced with CAR viruses; or their CAR-T cell expansion is failed. All of those patients must meet the following criteria:

  1. Eligible diseases: Acute lymphocytic leukemia (ALL), Chronic lymphocytic leukemia (CLL), Follicular lymphoma, Mantle cell lymphoma, B-cell prolymphocytic leukemia, and diffuse large cell lymphoma, previously identified as CD19+.
  2. Patients 3 years of age or older, and must have a life expectancy > 12 weeks.
  3. Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60.
  4. Females of child-bearing potential must have a negative pregnancy test and all subjects must agree to use an effective method of contraception for up to two weeks after the last infusion of CAR NK cells.
  5. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: White blood cell count (WBC) ≥ 2500c/ml, Platelets ≥ 50×10^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase < 1.5×upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration.
  6. 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).
  9. Patients using fludarabine or cladribine chemotherapy within 3 months prior to leukapheresis.
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): NCT02892695


Contacts
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Contact: Lin Yang, Ph.D. 86-512-65922190 lin.yang@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: NCT02892695    
Other Study ID Numbers: PG-119-001
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Prolymphocytic
Leukemia, Prolymphocytic, B-Cell
 Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Lymphoma, B-Cell