Adoptive Transfer of Specific Melanoma Antigens CD8+ T Cells in Metastatic Melanoma Patients: a Phase I/II Study
This study evaluates the safety as well as the potential clinical efficacy of an adoptive transfer of CD8+ T cells, sorted with HLA-peptide multimers and specific for Melan-A and MELOE-1 melanoma antigens, to patients suffering from advanced metastatic melanoma (stages IIIc and IV).
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
|Eligible Ages||18 Years - 75 Years|
- - Male or female ≥ 18 and ≤ 75 years - Patient expressing the HLA-A*0201 subtype of the human leukocyte antigen (HLA -A2) - Patient with metastatic melanoma stage IIIc or IV (AJCC 2010) except brain metastases - Tumor expressing the antigens Melan-A and MELOE-1 detected by RT-PCR - Absence of cerebral metastases - ECOG ≤ 2 or Karnofsky > 80 % - Prior adjuvant melanoma treatment (before metastatic stage) authorized (anti- BRAF, anti-CTLA4, IFN, TIL.
- - Disease measurable / evaluable within 28 days before the first administration of study
- Negative viral serology (HIV 1/2, Ag p24 , HTLV 1/2 , hepatitis B and C, syphilis)
- Results of analysis:
- Hemoglobin ≥ 10 g / dl or ≥ 6.25 mmol / l
- Leukocytes ≥ 4000/μl
- Lymphocytes ≥ 1500/μl
- Platelets ≥ 80.000/μl
- Creatinine ≤ 2.5 N
- Total bilirubin ≤ 3 N
- AST and ALT ≤ 3 N without liver metastases; ≤ 5 N with liver metastases
- Negative pregnancy test for women of childbearing age
- Patient affiliated to a social security system
- Patient who has signed informed consent
Exclusion Criteria:- Brain metastases - Ocular primitive melanoma - Treatment of metastatic melanoma by more than two lines (chemotherapy , immunotherapy, targeted therapy or radiotherapy) or within 4 weeks before the inclusion - Treatment with ipilimumab within 8 weeks before the inclusion - Known allergy to albumin - Contraindication to the use of vasopressors - Positive viral serology for HIV 1/2 , Ag p24 , HTLV 1/2, hepatitis B or C, or syphilis - Women who are pregnant, nursing or refusing to use contraceptives, women with no negative pregnancy test at baseline - Presence of a second active cancer (with the exception of cervical cancer in situ or skin cancer other than melanoma) - History of event or current event of a progressive or non-stabilized severe heart disease (congestive heart failure, coronary artery disease, uncontrolled hypertension, serious arrhythmias or ECG signs of previous myocardial infarction) - Uncontrolled thyroid dysfunction - Any serious acute or chronic illness (active infection requiring antibiotics, bleeding disorders or other condition requiring concomitant treatment not allowed in this study) - History of chronic autoimmune disease (Addison's disease, multiple sclerosis, Graves' disease, rheumatoid arthritis, systemic lupus erythematosus, .
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Phase 1/Phase 2|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Nantes University Hospital|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Nantes University Hospital
Nantes, , 44000
Amir Khammari, PhD