NL-OMON47165CompletedPhase 2
Multicenter phase I/IIa study using T-cell receptor gene therapy in metastatic melanoma - T-cell receptor gene therapy in melanoma
ederlands Kanker Instituut0 sites20 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Patients must be >= 18 years of age.
- •Patients must have inoperable stage IIIc or stage IV cutaneous melanoma (AJCC), including ocular or mucosal melanoma, progressing after standard of care therapy
- •Patients must be HLA-A2 positive.
- •The primary tumor and/or metastasis have to be positive for MART-1
- •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 a history of CNS metastases.
- •Patients with pleural effusion or ascites.
Investigators
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