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
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2015
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 19, 2015
CompletedFirst Posted
Study publicly available on registry
December 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedDecember 4, 2015
December 1, 2015
1 year
November 19, 2015
December 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects experiencing at least one dose limiting toxicity (DLT) of intravenous administration of 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.
252 days
Study Arms (3)
Arm 1（NKT cells single low dose）
EXPERIMENTALPatients 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.
Arm 2（NKT cells single high dose）
EXPERIMENTALPatients 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.
Arm 3（NKT cells multiple dose）
EXPERIMENTALPatients 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.
Interventions
autologous natural killer T cell
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Related Publications (3)
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.
PMID: 19097774BACKGROUNDHoos 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.
PMID: 17198079BACKGROUNDWolchok 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.
PMID: 19934295BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jun Guo, MD,PHD
Peking University Cancer Hospital & Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of department of renal cancer and melanoma
Study Record Dates
First Submitted
November 19, 2015
First Posted
December 2, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2016
Study Completion
October 1, 2017
Last Updated
December 4, 2015
Record last verified: 2015-12