Adoptive therapy with TCR gene-engineered T cells to treat patients with MAGE-C2-positive melanoma and head and neck cancer.

Adoptive therapy with TCR gene-engineered T cells to treat patients with MAGE-C2-positive melanoma and head and neck cancer. - MAGE-C2 TCR T cell therapy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52657

Enrollment

Registered

2019-04-29

Start date

2020-10-20

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

head and neck squamous cell carcinoma maligne melanoma skin cancer uveal melanoma

Interventions

Autologous T cells, obtained by leukapheresis, will be transduced with a retroviral vector encoding the MC2 TCR. Subsequently, these TCR T cells will be expanded ex vivo in the presence of defined c

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients must be >= 18 years of age. Patients must have: - inoperable stage IIIc or stage IV cutaneous melanoma, including ocular or mucosal melanoma, progressing after standard of care therapy, or recurrent/metastatic HNSCC Patients must be HLA-A2 positive. The primary tumor and/or metastasis have to be positive for MAGE-C2 Patients must have a clinical performance status of ECOG 0 or 1. 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 regimen. Patients must be able to understand and sign the Informed Consent document.

Exclusion criteria

Exclusion criteria: Life expectancy of less than three months. Requirement for systemic steroid therapy. Patients who have active/symptomatic CNS metastases. Patients with pleural effusion or ascites.

Design outcomes

Primary

Measure	Time frame
Primary endpoints: Phase I • AEs according to CTCAE 5.0 • Recommended Phase II dose • Feasibility to deliver this sequence of treatment Phase II • Objective response rate according to RECIST v1.1 • PFS • OS	—

Secondary

Measure	Time frame
Secondary and exploratory endpoints Phase I & II • Persistence and function of MC2-specific T cells in peripheral blood. • Systemic release of inflammatory cytokines after administration of autologous MC2 TCR T cells • Immune parameters, in particular T cell parameters, in blood and tumor tissues (when available) prior to and during treatment. • Global DNA hypomethylation and histone acetylation in PBMCs after epigenetic treatment and administration of autologous MC2 TCR T cells	—

Measure

Time frame

Secondary and exploratory endpoints Phase I & II • Persistence and function of MC2-specific T cells in peripheral blood. • Systemic release of inflammatory cytokines after administration of autologous MC2 TCR T cells • Immune parameters, in particular T cell parameters, in blood and tumor tissues (when available) prior to and during treatment. • Global DNA hypomethylation and histone acetylation in PBMCs after epigenetic treatment and administration of autologous MC2 TCR T cells

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)