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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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
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

Spots Global Cancer Trial Database for nkt

Every month we try and update this database with for nkt 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

Every month we try and update this database with for nkt 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 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.