Adoptive Transfer of Specific Melanoma Antigens CD8+ T Cells in Metastatic Melanoma Patients: a Phase I/II Study

NCT ID: NCT02424916

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-26
• Study Completion Date: 2019-05-06

Brief Summary

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).

Conditions

Metastatic Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous somatic cell therapy

Patients treated with melanoma antigens-specific CD8+ T lymphocytes followed by subcutaneous injections of Proleukin.

Group Type: EXPERIMENTAL

Melanoma antigens-specific CD8+ T lymphocytes

Intervention Type: BIOLOGICAL

The intervention uses an autologous somatic cell therapy medicinal product. It consists in the intravenous injection of melanoma antigens (Melan-A and MELOE-1) - specific CD8+ T lymphocytes followed by subcutaneous injections of Proleukin.

Interventions

Melanoma antigens-specific CD8+ T lymphocytes

The intervention uses an autologous somatic cell therapy medicinal product. It consists in the intravenous injection of melanoma antigens (Melan-A and MELOE-1) - specific CD8+ T lymphocytes followed by subcutaneous injections of Proleukin.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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 ≤ 1 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 treatment
• 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, ... ) with the exception of patients with active vitiligo or a history of vitiligo
• History of uveitis and retinopathy associated with melanoma
• Adults under a legal protection regime (guardianship, trusteeship, "sauvegarde de justice")

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UMR892

UNKNOWN

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nantes University Hospital

Nantes, , France

Countries

France

Other Identifiers

RC12_0261

Identifier Type: -

Identifier Source: org_study_id