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

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ClinicalTrials.gov Identifier: NCT02619058
Recruitment Status : Unknown
Verified December 2015 by Jun Guo, Beijing Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : December 2, 2015
Last Update Posted : December 4, 2015
Sponsor:
Information provided by (Responsible Party):
Jun Guo, Beijing Cancer Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Melanoma Biological: NKT cells Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Dose Escalation, Phase I Clinical Trial of Adoptive Transfer With Autologous NKT Cells in Metastatic Melanoma Patients
Study Start Date : October 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1(NKT cells single low dose)
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.
Biological: NKT cells
autologous natural killer T cell
Experimental: Arm 2(NKT cells single high dose)
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.
Biological: NKT cells
autologous natural killer T cell
Experimental: Arm 3(NKT cells multiple dose)
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.
Biological: NKT cells
autologous natural killer T cell



Primary Outcome Measures :
  1. Number of subjects experiencing at least one dose limiting toxicity (DLT) of intravenous administration of autologous NKT Cells in metastatic melanoma patients. [ Time Frame: 252 days ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have pathological or cytologically confirmed malignant melanoma with unresectable Stage III or Stage IV (including skin and distant lymph node metastasis M1a, lung metastasis M1b).
  • Patients who are resistant /refractory to approved therapies, or for whom no curative therapies are available.
  • Male or female, aged ≥18 and ≤70 years; ECOG performance status score of 0-2; Life expectancy of at least six months.
  • For women of childbearing potential, a negative pregnancy test within 7 days prior to the first treatment.
  • At least four weeks since prior other anti-tumor therapy, including endocrine, chemotherapy/radiotherapy and targeted therapy, at least six weeks since prior nitrosourea and mitomycin dosing, and have recovered from the adverse reactions due to prior therapy.
  • At least 4 weeks before prior surgery.
  • Must have one measurable or evaluable lesion according to RECIST 1.1
  • With enough tumor tissues and diagnosed by the designated laboratory.
  • Body weight >50kg.
  • Without functional disorder of major organs ( laboratory examination): Neutrophils≥1.5×10^9/L, lymphocyte≥1.0×10^9/L, PLT≥100×10^9/L, Hb≥110g/L; BUN and Cr within normal range; TBIL≤1.5 times upper limit; ALT/AST≤2.5 times upper limit; PT/APTT within normal range.
  • Without obvious hereditary disease.
  • Must sign a written informed consent form prior to entering the study, with good compliance.

Exclusion Criteria:

  • With extrapulmonary metastatic of melanoma, for instance, distant metastasis of liver, brain, bone, adrenal gland.
  • With serious internal disease, including serious heart disease, cerebral vascular disease, uncontrolled diabetes, uncontrolled hypertension, serious infections, active peptic ulcer, renal failure and respiratory failure.
  • Uncontrolled infectious diseases or other serious diseases, for example, HIV, Hepatitis B and Hepatitis C.
  • Uncontrolled brain metastases.
  • Lymphoma or leukemia patients.
  • Patients who have received bone marrow, stem cells or organ transplantation.
  • With immunodeficiency or autoimmune disease, leucoderma excluded.
  • Allergic constitution.
  • Chronic diseases needed immunosuppressive therapy or hormone therapy.
  • Patients treated with steroid hormone.
  • Unable to evaluate the immune status, or patients cannot comply with follow-up clinical evaluation.
  • Patients diagnosed with MDS (myelodysplastic syndromes).
  • Patients who are pregnant or breast-feeding.
  • Women (or patients' wife) of child-bearing without effective contraceptive measures.
  • Patients receiving any investigational drug or investigational treatment within 4 weeks prior to first dosing.
  • With uncontrolled mental disorders.

Information from the National Library of Medicine

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): NCT02619058


Contacts
Contact: Chuanliang Cui, MD 861088196951 1008ccl@163.com
Contact: Jun Guo, MD,PHD 861088196317 guoj307@126.com

Locations
China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Chuanliang Cui, MD    0086-10-88196951    1008ccl@163.com   
Contact: Jun Guo, MD,PHD    0086-10-88196317    guoj307@126.com   
Principal Investigator: Jun Guo, MD,PHD         
Sponsors and Collaborators
Beijing Cancer Hospital
Investigators
Principal Investigator: Jun Guo, MD,PHD Beijing Cancer Hospital

Publications:
Responsible Party: Jun Guo, Director of department of renal cancer and melanoma, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT02619058     History of Changes
Other Study ID Numbers: BCH-MM-150620
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: December 2015

Keywords provided by Jun Guo, Beijing Cancer Hospital:
NKT
metastatic melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas