Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Patients will receive intravenous administration of autologous NKT cells, the dose level is 1×10\^9 on d1, 2×10\^9 on d3, 4×10\^9 on d29, 8×10\^9 on d31.

Patients will receive intravenous administration of autologous NKT cells, the dose level is 5×10\^9 on d1, 5×10\^9 on d3, 5×10\^9 on d29, 5×10\^9 on d31.

Patients will receive intravenous administration of autologous NKT cells, the dose level is 5×10\^9 on d1, 5×10\^9 on d3 of each 28 days-cycle, the dosing will be ended after 8 cycles.

NKT cells

Chuanliang Cui, MD

Jun Guo, MD,PHD

Considerable progress in the treatment of metastatic melanoma has been made in the past 5years, with the approval of immune checkpoint-blocking antibodies and agents targeting BRAF mutation. Investigators conducted a open label, dose escalation, phase I clinical trial of to explore the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of intravenous administration of autologous NKT Cells in metastatic melanoma patients.

Considerable progress in the immunotherapy of metastatic melanoma has been made in the past 5 years, with the approval of immune checkpoint-blocking antibodies. NKT cells are a potent immunoregulatory cell population heavily implicated in promoting immunity to infection and cancer. And now with new generation of amplification method, more than 1,000 folds amplification of NKT cells can be obtained, so NKT cell based adoptive cell transfer is now available and might show its efficacy in melanoma. Investigators conducted this open label, dose escalation, phase I clinical trial of to explore the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of intravenous administration of autologous NKT Cells in metastatic melanoma patients.

A Clinical Trial of Adoptive Transfer With Autologous NKT Cells in Metastatic Melanoma Patients

An Open Label, Dose Escalation, Phase I Clinical Trial of Adoptive Transfer With Autologous NKT Cells in Metastatic Melanoma Patients

DLT is defined as any of the following toxicities assessed as at least possibly related to NKT cells by the investigator up to 28 days each cycle(up to 8 cycles,with 28 days' safety and efficacy follow-up after the end of the last cycle) after the end of adoptive transfer: any Grade greater than or equal to (\>=) 3 non-hematological toxicity, but excluding the conditions mentioned in the protocol; any Grade 4 neutropenia of greater than (\>)5 days duration or Grade \>=3 febrile neutropenia; any Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding; any Grade 4 anemia.

Peking University Cancer Hospital & Institute

Director of department of renal cancer and melanoma

Digestive System Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Breast Neoplasms

Pancreatic Neoplasms

Glioma

Prostatic Neoplasms

Lung Neoplasms

Carcinoma, Hepatocellular

Liver Neoplasms

Carcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Pancreatic Cancer

NKT cells treatment plus regular treatment

Han Weidong, Doctor

Zhang Minghui, Doctor

Feng Kaichao, Doctor

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.

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

Autologous Natural Killer T Cells Infusion for the Treatment of Cancer

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

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

Tsinghua University

Chinese PLA General Hospital

Fibrolamellar Carcinoma

Anti-Infective Agents

All Drugs and Chemicals

Vancomycin

Anti-Bacterial Agents

1,500 mg total daily dose, on days 1-21 of every 28 days cycle.

vancomycin

Tim F Greten, M.D.

Background:

Fibrolamellar Hepatocellular Carcinoma (FLC) is a rare liver cancer. It most often occurs in young people who have no history of liver disease. Unresectable FLC most often does not improve with surgery. Researchers think gut bacteria may affect liver cancer control. They want to see if a drug that controls a type of bacteria can help.

Objective:

To test if vancomycin is safe and tolerable for and can treat people with unresectable FLC.

Eligibility:

People ages 18 and older with FLC that isn t responsive to treatment

Design:

Participants will be screened with a medical history, physical exam, blood and urine tests, and CT or MRI scans. They will provide a tumor sample: If they do not have one, they will have a biopsy.

Participants will take vancomycin 3 times a day. They will take the drug by mouth. They will take the drug in 28-day cycles. They will take the drug daily for the first 3 weeks. They will not take the drug the last week.

Participants will keep a medication diary.

Participants will have blood and urine tests each cycle. They may provide stool samples.

Participants will have a biopsy before they start treatment. Then they will have one on day 1 of cycle 2.

Participants will have scans on day 1 of cycle 2. Then they will have scans about every 8 weeks.

Participants will continue treatment until their cancer gets worse or they can no longer tolerate the side effects.

Participants will have a follow-up visit about a month after they finish treatment. Then they will be followed every 6 months by phone or email.

Background:

* Fibrolamellar hepatocellular carcinoma (FLC) is a rare liver cancer (0.5-9% of primary liver cancers), which affects younger age groups and is not associated with underlying liver disease or elevated serum alpha fetoprotein (AFP) levels.
* Surgery, either liver resection (LR) or liver transplantation (LT), is the only potentially curative treatment for FLC patients with resectable disease. Disease recurrence after complete resection is high (33-100%). In patients with unresectable disease, median survival is less than 12 months; with no patient expected to survive beyond 5 years.
* The role of systemic chemotherapy and radiotherapy is poorly defined, and has been reported to have only a modest or no therapeutic effect. To date no targeted therapy has been shown to be of any value in FLC.
* In mouse models, oral vancomycin alters gut commensal bacteria thereby inducing a liver-selective anti-tumor effect by increasing hepatic CXCR6+ NKT cells via increased CXCL16 expression of liver sinusoidal endothelial cells.

Objective:

-To evaluate the effect of oral vancomycin therapy on the relative CXCR6 gene expression levels in the liver in paired pre- and on-treatment biopsy samples from hepatic lesions in patients with unresectable FLC

Eligibility:

* Histologically confirmed FLC, not amenable to potentially curative resection, transplantation or ablation.
* Liver lesion measurable by RECIST criteria, accessible for biopsy.
* Age greater than or equal to 18 years
* ECOG performance status less than or equal to 2
* Acceptable renal and normal liver function.
* Willingness to undergo pre- and on-treatment biopsies of liver tumor.

Design:

* This is a phase II study of oral vancomycin in patients with unresectable FLC.
* Up to 14 patients will be treated with oral vancomycin 500 mg tid daily (1,500 mg total daily dose) from days 1 to 21, in a 28-day cycles. After completion of the first cycle, initiation of concurrent treatment will be allowed. Patients will receive oral vancomycin until off treatment criteria are met.
* Patients will be evaluated for toxicity every 4 weeks by CTCAE v5.0, and for response at the end of the first cycle and thereafter every 8 (+/-3) weeks by RECIST 1.1.

Vancomycin in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLC) Oral

Phase II Study of Oral Vancomycin in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLC)

Change from baseline to 4 weeks after starting treatment in the relative CXCR6 gene expression level in the liver as determined by mRNA with Nanostring

National Cancer Institute (NCI)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Clinical Trial of Adoptive Transfer With Autologous NKT Cells in Metastatic Melanoma Patients	NCT02619058	Melanoma	NKT cells	18 Years - 70 Years	Peking University Cancer Hospital & Institute
Autologous Natural Killer T Cells Infusion for the Treatment of Cancer	NCT01801852	Breast Cancer Glioma Hepatocellular ... Squamous Cell L... Pancreatic Canc... Colon Cancer Prostate Cancer	NKT cells	18 Years - 90 Years	Chinese PLA General Hospital
A Clinical Trial of Adoptive Transfer With Autologous NKT Cells in Metastatic Melanoma Patients	NCT02619058	Melanoma	NKT cells	18 Years - 70 Years	Peking University Cancer Hospital & Institute
Vancomycin in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLC) Oral	NCT04025567	Metastatic Hepa... Hepatocellular ...	vancomycin	18 Years -	National Institutes of Health Clinical Center (CC)
Vancomycin in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLC) Oral	NCT04025567	Metastatic Hepa... Hepatocellular ...	vancomycin	18 Years -	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for nkt cells

Every month we try and update this database with for nkt cells cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nkt cells

Every month we try and update this database with for nkt cells cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nkt cells cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.