MAGE-C2 TCR T cell therapy
- Conditions
- advanced melanoma or HNSCC
- Registration Number
- 2024-516922-70-00
- Brief Summary
Phase I:
To study the safety and feasibility of AT with autologous MC2 TCR T cells, combined with epigenetic drug treatment, in patients with advanced melanoma or HNSCC. Adverse events (AEs) will be documented according to CTCAE v5.0.
To define the maximum tolerated dose (MTD) of MC2 TCR T cells in the combination treatment.
Phase II:
To assess the efficacy of AT with autologous MC2 TCR T cells at MTD, combined with epigenetic drug treatment, in patients with advanced melanoma or HNSCC.
Tumor response will be evaluated using RECIST v1 .1.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 20
18 years of age.
inoperable stage Ille 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 O 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 regime
Patients must be able to understand and sign the Informed Consent document.
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: Feasibility to deliver this sequence of treatmen Phase I: Feasibility to deliver this sequence of treatmen
Phase II: Objective response rate according to RECIST v1 .1 Phase II: Objective response rate according to RECIST v1 .1
Phase II: PFS Phase II: PFS
Phase I: AEs according to CTCAE 5.0 Phase I: AEs according to CTCAE 5.0
Phase I: Recommended Phase II dose Phase I: Recommended Phase II dose
Phase II: OS Phase II: OS
- Secondary Outcome Measures
Name Time Method Phase I and II: Persistence and function of MC2-specific T cells in peripheral blood. Phase I and II: Persistence and function of MC2-specific T cells in peripheral blood.
Phase I and II: Systemic release of inflammatory cytokines after administration of autologous MC2 TCR T cells Phase I and II: Systemic release of inflammatory cytokines after administration of autologous MC2 TCR T cells
Phase I and II: Immune parameters, in particular T cell parameters, in blood and tumor tissues (when available) prior to and during treatmen Phase I and II: Immune parameters, in particular T cell parameters, in blood and tumor tissues (when available) prior to and during treatmen
Phase I and II: Global DNA hypomethylation and histone acetylation in PBMCs after epigenetic treatment and administration of autologous MC2 TCR T cells Phase I and II: Global DNA hypomethylation and histone acetylation in PBMCs after epigenetic treatment and administration of autologous MC2 TCR T cells
Trial Locations
- Locations (1)
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
🇳🇱Rotterdam, Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)🇳🇱Rotterdam, NetherlandsAstrid van der VeldtSite contact0107041566invent.ctc@erasmusmc.nl