Age
Item
1. male or female patients aged ≥18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
2. performance status eastern cooperative oncology group (ecog) 0 or 1
boolean
C1520224 (UMLS CUI [1])
Metastatic melanoma Advanced | Metastatic Renal Cell Cancer Advanced | Non-small cell lung cancer metastatic Advanced | Standard therapy Refractory | Immunotherapy Disease indolent
Item
3. subjects with histological or cytological confirmation of advanced metastatic melanoma, renal cell carcinoma or nsclc which are refractory to current standard treatments or who have indolent disease for which immunotherapy may be beneficial
boolean
C0278883 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0278678 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C0278987 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C2936643 (UMLS CUI [4,1])
C0205269 (UMLS CUI [4,2])
C0021083 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0234227 (UMLS CUI [5,3])
Measurable Disease
Item
4. measurable disease according to the irrc criteria
boolean
C1513041 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function | Laboratory Results Required
Item
5. adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted <2 weeks prior to cycle 1:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C1254595 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
creatinine ≤ 1.5 x upper limit of normal (uln) or a calculated creatinine clearance ≥ 50 ml/min
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Serum total bilirubin measurement
Item
total bilirubin ≤ 1.5 x uln
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver
Item
alanine transaminase (alt) and aspartate transaminase (ast) ≤ 2.5 x uln or ≤ 5 x uln with liver metastases
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
White Blood Cell Count procedure
Item
white blood cell count ≥3.0 x 109/l
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count (anc) ≥1.5 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets ≥100 x 109/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
haemoglobin ≥ 10 g/dl
boolean
C0518015 (UMLS CUI [1])
Life Expectancy
Item
6. life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
T-Lymphocyte Expanding Proliferation Assay | T-Lymphocyte Doubling
Item
7. sufficient evidence of γδ t lymphocytes expansion in the proliferation assay at the first screening visit which will be a population doubling of γδ t lymphocytes ≥ 1.0 between 48-96 hours in culture.
boolean
C0039194 (UMLS CUI [1,1])
C0205229 (UMLS CUI [1,2])
C3899698 (UMLS CUI [1,3])
C0039194 (UMLS CUI [2,1])
C1705764 (UMLS CUI [2,2])
Informed Consent
Item
8. able to give informed, written consent
boolean
C0021430 (UMLS CUI [1])
Female Sterilization | Gender Partner Female Sterilization | Postmenopausal state | Gender Contraceptive methods Quantity | Contraception, Barrier | Gender Urine pregnancy test negative | Gender Serum pregnancy test negative | Gender Breast Feeding Absent
Item
9. for female patients and female partners of male patients: must be surgically sterile, postmenopausal, or compliant with two forms of contraception (one of which must be a barrier method) during and for 6 months after the treatment period; female patients must have a negative urine or serum pregnancy test at screening and must not be breast-feeding.
boolean
C0015787 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C0015787 (UMLS CUI [2,3])
C0232970 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0004764 (UMLS CUI [5])
C0079399 (UMLS CUI [6,1])
C0430057 (UMLS CUI [6,2])
C0079399 (UMLS CUI [7,1])
C0430061 (UMLS CUI [7,2])
C0079399 (UMLS CUI [8,1])
C0006147 (UMLS CUI [8,2])
C0332197 (UMLS CUI [8,3])
Cancer Other Primary | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Curative treatment Malignant Neoplasm | Exception Recurrent disease Absent
Item
1. other primary cancers apart from non-melanoma skin cancers, carcinoma - in situ of the cervix, or a prior cancer treated with curative intent more than 5 years ago without any evidence or recurrent disease
boolean
C1707251 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0006826 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0277556 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Sepsis Uncontrolled
Item
2. uncontrolled systemic infection
boolean
C0243026 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Steroid therapy Systemic | Immunosuppressive Agents
Item
3. systemic steroid therapy or other immunosuppressants
boolean
C0149783 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2])
Diphosphonates | zoledronate
Item
4. treatment with bisphosphonates, for instance zoledronate, in the previous 30 days and throughout the trial
boolean
C0012544 (UMLS CUI [1])
C0392938 (UMLS CUI [2])
New York Heart Association Classification | Myocardial Infarction
Item
5. new york heart association (nyha) functional class ≥3 or myocardial infarction within 6 months
boolean
C1275491 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
Cardiac Arrhythmia Uncontrolled | Exception ATRIAL FIBRILLATION ASYMPTOMATIC
Item
6. clinically-significant uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation not requiring therapy.
boolean
C0003811 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0741277 (UMLS CUI [2,2])
Ulcerative Colitis | Inflammatory Bowel Diseases | Addison Disease
Item
7. ulcerative colitis / inflammatory bowel disease, addison's disease
boolean
C0009324 (UMLS CUI [1])
C0021390 (UMLS CUI [2])
C0001403 (UMLS CUI [3])
Pregnancy | Breast Feeding | Urine pregnancy test Performed | Serum pregnancy test Performed
Item
8. pregnancy or lactation before or during the trial. a urine or serum pregnancy test will be carried out at screening
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0430056 (UMLS CUI [3,1])
C0884358 (UMLS CUI [3,2])
C0430064 (UMLS CUI [4,1])
C0884358 (UMLS CUI [4,2])
Investigational New Drugs | Study Subject Participation Status | Interventional Study
Item
9. taking any other investigational medicinal product (imp) or participation in another interventional clinical trial in the previous 30 days
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C3274035 (UMLS CUI [3])
Cancer treatment Systemic | Tyrosine kinase inhibitor | Chemotherapy | Immunotherapy | Hormone Therapy | Therapeutic radiology procedure | Mitomycin | Nitrosoureas
Item
10. less than 4 weeks since systemic anti-cancer therapy (tyrosine kinase inhibitors, chemotherapy, immunotherapy, hormonal therapy, radiotherapy) and less than 6 weeks since mitomycin c and nitrosureas
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1268567 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C0279025 (UMLS CUI [5])
C1522449 (UMLS CUI [6])
C0002475 (UMLS CUI [7])
C0028210 (UMLS CUI [8])
Substance Use Disorders Interfere with Study Subject Participation Status | Medical condition Interferes with Study Subject Participation Status | Psychological Factors Interfere with Study Subject Participation Status | Social Conditions Interfere with Study Subject Participation Status | Substance Use Disorders Interfere with Evaluation Research results | Medical condition Interferes with Evaluation Research results | Psychological Factors Interfere with Evaluation Research results | Social Conditions Interfere with Evaluation Research results
Item
11. substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the trial or evaluation of the trial results
boolean
C0038586 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0033898 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0037403 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C0038586 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C1261322 (UMLS CUI [5,3])
C0683954 (UMLS CUI [5,4])
C3843040 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C1261322 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
C0033898 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C1261322 (UMLS CUI [7,3])
C0683954 (UMLS CUI [7,4])
C0037403 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C1261322 (UMLS CUI [8,3])
C0683954 (UMLS CUI [8,4])
Condition Study Subject Participation Status Inappropriate
Item
12. any other condition considered by a trial physician to be inappropriate for inclusion
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
Blood Coagulation Disorders | Leukapheresis | Medical contraindication Heparin | Thrombocytopenia | Platelet Count measurement | Cerebral Hemorrhage | Peptic Ulcer | Ophthalmologic Surgical Procedures | Neurosurgical Procedures | Heparin allergy | Heparin-induced thrombocytopenia Type | Spontaneous hemorrhage | Hemophilia
Item
13. coagulation disorders - contraindications should also be taken into consideration during the leukapheresis procedure these include, contraindications to heparin which are: significant thrombocytopenia (platelet count less than 50x109/litre); recent cerebral haemorrhage; peptic ulcer; recent surgery to eye or nervous system; hypersensitivity to heparin; past history of type ii heparin induced thrombocytopenia; past history of significant spontaneous haemorrhage; known haemophilia or other bleeding disorder.
boolean
C0005779 (UMLS CUI [1])
C0023416 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0019134 (UMLS CUI [3,2])
C0040034 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C2937358 (UMLS CUI [6])
C0030920 (UMLS CUI [7])
C0038901 (UMLS CUI [8])
C0524850 (UMLS CUI [9])
C0571776 (UMLS CUI [10])
C0272285 (UMLS CUI [11,1])
C0332307 (UMLS CUI [11,2])
C1321132 (UMLS CUI [12])
C0684275 (UMLS CUI [13])