Actively Recruiting
MAGE-C2 TCR T Cell Trial to Treat Melanoma and Head and Neck Cancer
Led by Erasmus Medical Center · Updated on 2023-12-04
20
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
Sponsors
E
Erasmus Medical Center
Lead Sponsor
L
Ludwig Institute for Cancer Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Single-centre, first-in-man phase I/II trial to demonstrate safety and efficacy of MAGE-C2/HLA-A2 TCR T cells (MC2 TCR T cells) in advanced melanoma (MEL) and head-and-neck carcinoma (HNSCC).
CONDITIONS
Official Title
MAGE-C2 TCR T Cell Trial to Treat Melanoma and Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Age 18 years or older
- Diagnosis of unresectable or metastatic cutaneous or mucosal melanoma without standard treatment options
- Diagnosis of metastatic uveal melanoma progressing after standard therapy if available
- Diagnosis of recurrent or metastatic head and neck squamous cell carcinoma without standard treatment options
- Positive for HLA-A2*0201
- Tumor or metastasis positive for MAGE-C2 in more than 5% of tumor cells by immunohistochemistry
- Measurable disease according to RECIST v1.1
- At least one lesion suitable for sequential mandatory tumor biopsies
- ECOG performance status of 0 or 1 with life expectancy of 12 weeks or more
- For melanoma patients, documented disease progression after standard systemic therapy with appropriate washout periods
- For head and neck cancer patients, documented disease progression and ineligible or unwilling for platinum-based chemotherapy
- Willingness to use highly effective birth control during treatment and for four months after
- Laboratory values meeting minimum hematology, chemistry, and serology requirements at screening without growth factors or transfusions
You will not qualify if you...
- Symptomatic brain metastases unless definitively treated
- Active or new progressive brain metastases at study entry unless treated or stable
- Presence of leptomeningeal metastasis
- Malignant pleural effusion or ascites
- Systemic chronic steroid or immunosuppressive therapy within specified time frames prior to treatment
- Active or suspected autoimmune disease except specified controlled conditions
- Active systemic infections, coagulation disorders, or other major medical illnesses
- Recent significant cardiac events within 6 months
- Unresolved toxicities from previous treatments above grade 1
- Pregnancy or breastfeeding; negative pregnancy test required for women of childbearing age
- Use of live vaccines within 3 months before treatment
- Active infections requiring systemic antibiotics at treatment start
- Prior allogenic bone marrow or solid organ transplant
- Known hypersensitivity to investigational drugs
- Other malignant diseases except specified cured or resected cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Erasmus Medical Center
Rotterdam, Netherlands, 3015GD
Actively Recruiting
Research Team
A
A.A.M. van der Veldt, MD, PhD
CONTACT
R
R. Debets, PhD, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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