A Clinical Trial of Adoptive Transfer With Autologous NKT Cells in Metastatic Melanoma Patients
NCT ID: NCT02619058
Last Updated: 2015-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2015-10-31
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
NKT cells
autologous natural killer T cell
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.
NKT cells
autologous natural killer T cell
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.
NKT cells
autologous natural killer T cell
Interventions
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NKT cells
autologous natural killer T cell
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
No
Sponsors
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Peking University Cancer Hospital & Institute
OTHER
Responsible Party
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Jun Guo
Director of department of renal cancer and melanoma
Principal Investigators
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Jun Guo, MD,PHD
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
Hoos A, Parmiani G, Hege K, Sznol M, Loibner H, Eggermont A, Urba W, Blumenstein B, Sacks N, Keilholz U, Nichol G; Cancer Vaccine Clinical Trial Working Group. A clinical development paradigm for cancer vaccines and related biologics. J Immunother. 2007 Jan;30(1):1-15. doi: 10.1097/01.cji.0000211341.88835.ae.
Wolchok JD, Hoos A, O'Day S, Weber JS, Hamid O, Lebbe C, Maio M, Binder M, Bohnsack O, Nichol G, Humphrey R, Hodi FS. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res. 2009 Dec 1;15(23):7412-20. doi: 10.1158/1078-0432.CCR-09-1624. Epub 2009 Nov 24.
Other Identifiers
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BCH-MM-150620
Identifier Type: -
Identifier Source: org_study_id