Retroviral vector containing the common gamma chain cDNA; Autologous tumour-infiltrating lymphocytes for Advanced melanoma | Head and neck squamous cell carcinoma

Inclusion criteria

• {"criterion_text":"- 18 years of age."}
• {"criterion_text":"- inoperable stage Ille or stage IV cutaneous melanoma, including ocular or mucosal melanoma, progressing after standard of care therapy, or recurrent/metastatic HNSCC"}
• {"criterion_text":"- Patients must be HLA-A2 positive."}
• {"criterion_text":"- The primary tumor and/or metastasis have to be positive for MAGE-C2"}
• {"criterion_text":"- Patients must have a clinical performance status of ECOG O or 1"}
• {"criterion_text":"- Patients of both genders must be willing to practice a highly effective method of birth control during treatment and for four months after receiving the preparative regime"}
• {"criterion_text":"- Patients must be able to understand and sign the Informed Consent document."}

Exclusion criteria

• {"criterion_text":"- Life expectancy of less than three months."}
• {"criterion_text":"- Requirement for systemic steroid therapy"}
• {"criterion_text":"- Patients who have active/symptomatic CNS metastases"}
• {"criterion_text":"- Patients with pleural effusion or ascites."}

Primary endpoints

• {"endpoint_text":"- Phase I: AEs according to CTCAE 5.0","definition_or_measurement_approach":"Adverse events will be documented according to CTCAE v5.0."}
• {"endpoint_text":"- Phase I: Recommended Phase II dose","definition_or_measurement_approach":"Determination of the recommended Phase II dose based on Phase I dose-escalation/MTD assessment."}
• {"endpoint_text":"- Phase I: Feasibility to deliver this sequence of treatmen","definition_or_measurement_approach":"Assessment of feasibility to deliver the treatment sequence (no additional measurement details provided)."}
• {"endpoint_text":"- Phase II: Objective response rate according to RECIST v1 .1","definition_or_measurement_approach":"Tumor response evaluated using RECIST v1.1."}
• {"endpoint_text":"- Phase II: PFS","definition_or_measurement_approach":"Progression-free survival (PFS) as an outcome (no further definition provided)."}
• {"endpoint_text":"- Phase II: OS","definition_or_measurement_approach":"Overall survival (OS) as an outcome (no further definition provided)."}

Secondary endpoints

• {"endpoint_text":"- Phase I and II: Persistence and function of MC2-specific T cells in peripheral blood.","definition_or_measurement_approach":"Assessment of persistence and function of MC2-specific T cells in peripheral blood (details not provided)."}
• {"endpoint_text":"- Phase I and II: Systemic release of inflammatory cytokines after administration of autologous MC2 TCR T cells","definition_or_measurement_approach":"Measurement of systemic inflammatory cytokine release after administration (details not provided)."}
• {"endpoint_text":"- Phase I and II: Immune parameters, in particular T cell parameters, in blood and tumor tissues (when available) prior to and during treatmen","definition_or_measurement_approach":"Measurement of immune parameters in blood and tumor tissues prior to and during treatment (details not provided)."}
• {"endpoint_text":"- Phase I and II: Global DNA hypomethylation and histone acetylation in PBMCs after epigenetic treatment and administration of autologous MC2 TCR T cells","definition_or_measurement_approach":"Evaluation of global DNA hypomethylation and histone acetylation in PBMCs after epigenetic treatment and cell administration (details not provided)."}

Netherlands

Earliest CTIS Part Ii Submission Date

15-11-2024

Latest Decision Or Authorization Date

31-03-2026

Processing Time Days

501

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands