NCT02742727

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

March 31, 2016

Last Update Submit

December 4, 2016

Conditions

Acute Myeloid LeukemiaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaT-cell Prolymphocytic LeukemiaT-cell Large Granular Lymphocytic LeukemiaPeripheral T-cell Lymphoma, NOSAngioimmunoblastic T-cell LymphomaExtranodal NK/T-cell Lymphoma, Nasal TypeEnteropathy-type Intestinal T-cell LymphomaHepatosplenic T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Adverse events attributed to the administration of the anti-CD7 CAR-pNK cells

    Determine the toxicity profile of the CD7 targeted CAR-pNK cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.

    2 years

Secondary Outcomes (2)

  • Clinical response to CD7 CAR-pNK cell infusions

    Safety follow-up is 100 days from last CAR-pNK infusion

  • Determine the existence of CD7-CAR-pNK in vivo

    1 year

Study Arms (1)

CAR-pNK Cell immunotherapy

EXPERIMENTAL

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

Interventions

anti-CD7 CAR-pNK cellsBIOLOGICAL

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.

Also known as: chimeric antigen receptor NK cells with specificity for CD7
CAR-pNK Cell immunotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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
  • Patients 18 years of age or older, and must have a life expectancy \> 12 weeks.
  • CD7 is expressed in malignancy tissues by immuno-histochemical (IHC) or Flow cytometry.
  • Assessable disease as measured by laboratory and bone marrow examinations.
  • Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60.
  • 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.
  • 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.
  • Ability to give informed consent.

You may not qualify if:

  • Patients with symptomatic central nervous system (CNS) involvement.
  • Pregnant or nursing women may not participate.
  • Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • 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.
  • Previously treatment with any gene therapy products.
  • The existence of unstable or active ulcers or gastrointestinal bleeding.
  • Patients with a history of organ transplantation or are waiting for organ transplantation.
  • Patients need anticoagulant therapy (such as warfarin or heparin).
  • Patients need long-term antiplatelet therapy (aspirin at a dose \> 300mg/d; clopidogrel at a dose \> 75mg/d).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Suzhou, Jiangsu, 215123, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 28054442DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, AcutePrecursor T-Cell Lymphoblastic Leukemia-LymphomaLeukemia, Prolymphocytic, T-CellLeukemia, Large Granular LymphocyticLymphoma, T-CellImmunoblastic LymphadenopathyLymphoma, Extranodal NK-T-CellEnteropathy-Associated T-Cell Lymphoma

Interventions

Sensitivity and Specificity

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, ProlymphocyticLeukemia, T-CellLymphoma, Non-HodgkinLymphomaLymphadenopathy

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesStatistics as TopicMathematical ConceptsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Lin Yang, Ph.D.

    PersonGen BioTherapeutics (Suzhou) Co., Ltd.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Yang, Ph.D.

CONTACT

86-512-65922190info@persongen.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 19, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2018

Last Updated

December 6, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will share

Locations

CN(1)