CAR-pNK Cell Immunotherapy in MUC1 Positive Relapsed or Refractory Solid Tumor
Study Evaluating the Efficacy and Safety of Chimeric Antigen Receptor-Modified pNK Cells in MUC1 Positive Advanced Refractory or Relapsed Solid Tumor
1 other identifier
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 hepatocellular-carcinoma
Started Jul 2016
Shorter than P25 for phase_1 hepatocellular-carcinoma
1 active site
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
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 14, 2016
CompletedFirst Posted
Study publicly available on registry
July 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedDecember 6, 2016
December 1, 2016
1 year
July 14, 2016
December 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Phase I: Adverse events attributed to the administration of the anti-MUC1 CAR-pNK cells
Determine the toxicity profile of the MUC1 targeted CAR-pNK cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
2 years
Secondary Outcomes (1)
Phase II: Objective Response Rate
2 years
Study Arms (1)
CAR-pNK Cell immunotherapy
EXPERIMENTALEnrolled patients will receive CAR-pNK cell immunotherapy with a novel specific chimeric antigen receptor targeting MUC1 antigen by infusion.
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- 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.
- Patients 18 years of age or older, and must have a life expectancy \> 12 weeks.
- MUC1 is expressed in malignancy tissues by immuno-histochemical (IHC).
- Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60.
- Presence of measurable disease by RECIST.
- 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: 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.
- 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.
- Active 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.
- 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
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.lead
- The First People's Hospital of Hefeicollaborator
- Hefei Binhu Hospitalcollaborator
Study Sites (1)
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Suzhou, Jiangsu, 215123, China
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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lin Yang, Ph.D.
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Central Study Contacts
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
July 14, 2016
First Posted
July 21, 2016
Study Start
July 1, 2016
Primary Completion
July 1, 2017
Study Completion
July 1, 2018
Last Updated
December 6, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will share