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

Recruiting

Conditions: 10040900
maligne melanoma
skin cancer
head and neck squamous cell carcinoma
uveal melanoma
10030054
10027656

Registration Number: NL-OMON52657

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

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

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints:<br /><br>Phase I<br /><br>• AEs according to CTCAE 5.0<br /><br>• Recommended Phase II dose<br /><br>• Feasibility to deliver this sequence of treatment<br /><br><br /><br>Phase II<br /><br>• Objective response rate according to RECIST v1.1<br /><br>• PFS<br /><br>• OS</p><br>

Secondary Outcome Measures

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