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CAR-pNK Cell Immunotherapy in CD7 Positive Leukemia and Lymphoma

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ClinicalTrials.gov Identifier: NCT02742727
Recruitment Status : Recruiting
First Posted : April 19, 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.

Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of CAR-pNK cell immunotherapy in patients with CD7 positive relapsed or refractory Leukemia and Lymphoma.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Precursor T-Cell Lymphoblastic Leukemia-Lymphoma T-cell Prolymphocytic Leukemia T-cell Large Granular Lymphocytic Leukemia Peripheral T-cell Lymphoma, NOS Angioimmunoblastic T-cell Lymphoma Extranodal NK/T-cell Lymphoma, Nasal Type Enteropathy-type Intestinal T-cell Lymphoma Hepatosplenic T-cell Lymphoma Biological: anti-CD7 CAR-pNK cells Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chimeric Antigen Receptor-Modified pNK Cells for CD7 Positive Relapsed or Refractory Leukemia and Lymphoma
Study Start Date : March 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2018


Arm Intervention/treatment
Experimental: CAR-pNK Cell immunotherapy
Enrolled patients will receive CAR-pNK cell immunotherapy with a novel specific chimeric antigen receptor targeting CD7 antigen by infusion.
Biological: anti-CD7 CAR-pNK cells
The allogeneic NK cells (NK-92 cell line for clinical use) are engineered to contain anti-CD7 attached to TCRzeta, CD28 and 4-1BB signaling domains. These modified cells are called chimeric antigen receptor NK cells with specificity for CD7.
Other Name: chimeric antigen receptor NK cells with specificity for CD7




Primary Outcome Measures :
  1. Adverse events attributed to the administration of the anti-CD7 CAR-pNK cells [ Time Frame: 2 years ]
    Determine the toxicity profile of the CD7 targeted CAR-pNK cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.


Secondary Outcome Measures :
  1. Clinical response to CD7 CAR-pNK cell infusions [ Time Frame: Safety follow-up is 100 days from last CAR-pNK infusion ]
    Patients with measurable disease will be assessed for the response of their disease to CD7 CAR-pNK cell treatment.

  2. Determine the existence of CD7-CAR-pNK in vivo [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Male and female subjects with CD7+ malignancies in patients with no available curative treatment options who have limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled:

  1. Eligible diseases: CD7 positive relapsed or refractory Leukemia and Lymphoma. ᅳ Acute myeloid leukemia, previously identified as CD7+ ᅳ Precursor T lymphoblast leukemia/lymphoma ᅳ T-cell prolymphocytic leukemia ᅳ T-cell large granular lymphocytic leukemia ᅳ Peripheral T-cell lymphoma, NOS ᅳ Angioimmunoblastic T-cell lymphoma ᅳ Extranodal NK/T-cell lymphoma, nasal type ᅳ Enteropathy-type intestinal T-cell lymphoma ᅳ Hepatosplenic T-cell lymphoma
  2. Patients 18 years of age or older, and must have a life expectancy > 12 weeks.
  3. CD7 is expressed in malignancy tissues by immuno-histochemical (IHC) or Flow cytometry.
  4. Assessable disease as measured by laboratory and bone marrow examinations.
  5. Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60.
  6. 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-pNK cells.
  7. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: 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.
  8. Ability to give informed consent.

Exclusion Criteria:

  1. Patients with symptomatic central nervous system (CNS) involvement.
  2. Pregnant or nursing women may not participate.
  3. Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  4. 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.
  5. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
  6. Previously treatment with any gene therapy products.
  7. The existence of unstable or active ulcers or gastrointestinal bleeding.
  8. Patients with a history of organ transplantation or are waiting for organ transplantation.
  9. Patients need anticoagulant therapy (such as warfarin or heparin).
  10. Patients need long-term antiplatelet therapy (aspirin at a dose > 300mg/d; clopidogrel at a dose > 75mg/d).

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): NCT02742727


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

Locations
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
Investigators
Principal Investigator: Lin Yang, Ph.D. PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT02742727     History of Changes
Other Study ID Numbers: PG-107-002
First Posted: April 19, 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:
Lymphoma
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Immunoblastic Lymphadenopathy
Leukemia, Prolymphocytic
Lymphoma, Extranodal NK-T-Cell
Intestinal Diseases
Leukemia, Large Granular Lymphocytic
Leukemia, Prolymphocytic, T-Cell
Enteropathy-Associated T-Cell Lymphoma
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Myeloid
Lymphoma, Non-Hodgkin
Lymphadenopathy
Gastrointestinal Diseases
Digestive System Diseases
Leukemia, T-Cell