Autologous Natural Killer T Cells Infusion for the Treatment of Cancer

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and effectiveness of natural killer T (NKT) cell-based autologous adoptive immunotherapy in subjects with metastatic, treatment-refractory breast cancer, glioma, hepatocellular carcinoma, squamous cell lung cancer, pancreatic cancer, colon cancer or prostate cancer.

Detailed Description
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A randomized controlled trial on the efficacy and safety of autologous natural killer T (NKT) cells infusion treatment in advanced cancer.

Official Title
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Phase 1 Study of Autologous Natural Killer T Cells Infusion in Treating Patients With Tumors

Conditions
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Breast Cancer, Glioma, Hepatocellular Cancer, Squamous Cell Lung Cancer, Pancreatic Cancer, Colon Cancer, Prostate Cancer

Intervention / Treatment
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* Biological: NKT cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:•Male or female not less than 18 years of age or over 80 years of age. Life expectancy of ≥ 24 weeks as measured by the Eastern Cooperative Oncology Group (ECOG) performance status. Subjects must present with one of the following disease pathologies: Breast Cancer, Glioma, Hepatocellular Cancer, Squamous Cell Lung Cancer, Pancreatic Cancer, Colon Cancer or Prostate Cancer The pathology must be an assessable disease (measurable by CT scan or MRI) that is refractory to standard treatments (e.g., chemotherapy, radiation, etc.) Negative for hepatitis B, hepatitis C, HIV, and CMV. Subjects must present with leukocyte counts above 3,000/μL and platelet counts above 100,000/ μL. Subjects must present with minimum hemoglobin levels of 10. If female, subject is surgically sterile (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), post menopausal (no menses >12 months), or using a high-efficiency method of contraception such as implant, injectable, combination oral contraceptive, intrauterine device (IUD) or sexual abstinence, or has a vasectomized partner. If female of childbearing potential, subject is not pregnant, breast-feeding or planning a pregnancy during the study, and has a negative pregnancy test on screening visit. Able to comprehend and sign an informed consent document and comply with the requirements of the study. Exclusion Criteria:•No measurable malignant disease by CT scan or tumor markers. Life expectancy of ≤ 24 weeks as measured by the Eastern Cooperative Oncology Group (ECOG) performance status. Age of less than 18 years or over 80 years of age. Documented/confirmed positive testing for hepatitis B, hepatitis C, HIV, or CMV. Prior or current history of autoimmune disease. Pregnant or lactating women. Leukocyte count < 3,000 /μL prior to leukapheresis. Platelet count < 100,000/μL prior to leukapheresis. Hemoglobin levels below 10. PTT (prothrombin time) of < 12 seconds or > than 15 seconds. aPTT (activated partial thromboplastin time) of < 25 seconds or > than 39 seconds. Failure or refusal to sign informed consent for the study. Culture fails to meet specifications for study. Subject has any other medical condition that, in the opinion of the investigator, might significantly affect the ability to safely participate in the study or affect the conduct of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NKT cells<br>NKT cells treatment plus regular treatment | Biological: NKT cells<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of study related adverse events | defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment | Until week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-tumor responses to NKT cells infusions |  | at least once within 30 days afther completing four-cycle treatment |