CAR-pNK Cell Immunotherapy in MUC1 Positive Relapsed or Refractory Solid Tumor
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|ClinicalTrials.gov Identifier: NCT02839954|
Recruitment Status : Unknown
Verified December 2016 by PersonGen BioTherapeutics (Suzhou) Co., Ltd..
Recruitment status was: Recruiting
First Posted : July 21, 2016
Last Update Posted : December 6, 2016
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|Condition or disease||Intervention/treatment||Phase|
|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||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study Evaluating the Efficacy and Safety of Chimeric Antigen Receptor-Modified pNK Cells in MUC1 Positive Advanced Refractory or Relapsed Solid Tumor|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2018|
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
Other Name: Chimeric antigen receptor NK cells with specificity for MUC1
- Phase I: Adverse events attributed to the administration of the anti-MUC1 CAR-pNK cells [ Time Frame: 2 years ]Determine the toxicity profile of the MUC1 targeted CAR-pNK cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
- Phase II: Objective Response Rate [ Time Frame: 2 years ]The 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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.
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
- 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).
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): NCT02839954
|Contact: Lin Yang, Ph.D.||email@example.com|
|PersonGen BioTherapeutics (Suzhou) Co., Ltd.||Recruiting|
|Suzhou, Jiangsu, China, 215123|
|Contact: Lin Yang, Ph.D. 86-512-65922190 firstname.lastname@example.org|
|Principal Investigator: Yangyi Bao, MD|
|Principal Investigator: Xiang Sun, MD|
|Principal Investigator: Lin Yang, Ph.D|
|Principal Investigator:||Lin Yang, Ph.D.||PersonGen BioTherapeutics (Suzhou) Co., Ltd.|
|Responsible Party:||PersonGen BioTherapeutics (Suzhou) Co., Ltd.|
|Other Study ID Numbers:||
|First Posted:||July 21, 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|
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Endocrine Gland Neoplasms
Endocrine System Diseases