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Clinical Trial Record

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CAR-pNK Cell Immunotherapy in MUC1 Positive Relapsed or Refractory Solid Tumor

2016-07

2017-07

2018-07

10

Study Overview

CAR-pNK Cell Immunotherapy in MUC1 Positive Relapsed or Refractory Solid Tumor

The purpose of this study is to evaluate the safety and effectiveness of CAR-pNK cell immunotherapy in patients with MUC1 positive relapsed or refractory solid tumor.

N/A

  • Hepatocellular Carcinoma
  • Non-small Cell Lung Cancer
  • Pancreatic Carcinoma
  • Triple-Negative Invasive Breast Carcinoma
  • Malignant Glioma of Brain
  • Colorectal Carcinoma
  • Gastric Carcinoma
  • BIOLOGICAL: anti-MUC1 CAR-pNK cells
  • PG-121-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2016-07-14  

N/A  

2016-12-04  

2016-07-20  

N/A  

2016-12-06  

2016-07-21  

N/A  

2016-12  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: CAR-pNK Cell immunotherapy

Enrolled patients will receive CAR-pNK cell immunotherapy with a novel specific chimeric antigen receptor targeting MUC1 antigen by infusion.

BIOLOGICAL: anti-MUC1 CAR-pNK cells

Primary Outcome MeasuresMeasure DescriptionTime Frame
Phase I: Adverse events attributed to the administration of the anti-MUC1 CAR-pNK cellsDetermine the toxicity profile of the MUC1 targeted CAR-pNK cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.2 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Phase II: Objective Response RateThe objective response rate (ORR) is defined as the proportion of patients who achieve radiographic partial or complete response (PR or CR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guideline.2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Lin Yang, Ph.D.

Phone Number: 86-512-65922190

Email: info@persongen.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    Male and female subjects with MUC1+ 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: MUC1+ malignant glioma of brain, colorectal carcinoma, gastric carcinoma, hepatocellular carcinoma, non-small cell lung cancer, pancreatic carcinoma and triple-negative basal-like breast carcinoma. 2. Patients 18 years of age or older, and must have a life expectancy > 12 weeks. 3. MUC1 is expressed in malignancy tissues by immuno-histochemical (IHC). 4. Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60. 5. Presence of measurable disease by RECIST. 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: 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. 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. Active 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. The existence of unstable or active ulcers or gastrointestinal bleeding. 7. Patients with a history of organ transplantation or are waiting for organ transplantation. 8. Patients need anticoagulant therapy (such as warfarin or heparin). 9. Patients need long-term antiplatelet therapy (aspirin at a dose > 300mg/d; clopidogrel at a dose > 75mg/d).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • The First People's Hospital of Hefei
  • Hefei Binhu Hospital
  • PRINCIPAL_INVESTIGATOR: Lin Yang, Ph.D., PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.
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