NCT02944162

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.

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 Oct 2016

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

October 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

December 6, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

October 23, 2016

Last Update Submit

December 4, 2016

Conditions

Acute Myelogenous LeukemiaAcute Myeloid LeukemiaAcute Myeloid Leukemia With MaturationAcute Myeloid Leukemia Without MaturationANLL

Keywords

AMLCD33CAR-NK

Outcome Measures

Primary Outcomes (1)

  • Adverse events attributed to the administration of the anti-CD33 CAR-NK cells

    Defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment

    One year

Secondary Outcomes (1)

  • Objective Response Rate

    Up to one year

Study Arms (1)

CAR-NK Cell immunotherapy

EXPERIMENTAL

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

Interventions

anti-CD33 CAR-NK cellsBIOLOGICAL

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.

Also known as: Chimeric antigen receptor NK92 cells with specificity for CD33
CAR-NK Cell immunotherapy

Eligibility Criteria

Age3 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • CD33+ acute myeloid leukemia CR (complete remission) can not be achieved after at least 2 prior combination chemotherapy regimens.
  • 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.
  • Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \< 1 year).
  • 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.
  • Residual disease after primary therapy and not eligible for autologous SCT.
  • 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.

You may not qualify if:

  • Pregnant or nursing women may not participate.
  • Active HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at the time of screening.
  • 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.
  • History of severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or aldesleukin.
  • The existence of unstable or active ulcers or gastrointestinal bleeding.
  • 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, Acute

Interventions

Sensitivity and Specificity

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

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

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

October 23, 2016

First Posted

October 25, 2016

Study Start

October 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2018

Last Updated

December 6, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

(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.

Locations

CN(1)