Status:
NO_LONGER_AVAILABLE
Single Patient Protocol: A Phase II Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in a Patient With Metastatic Cancer Plus the Administration of Pembrolizumab
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Brief Summary
Single Patient Expanded Access
Detailed Description
Background: Please refer to National Cancer Institute Surgery Branch (NCI-SB) protocol 18-C-0049, Amendment F. Objective: Under Individual Patient Expanded Access, to treat a patient with metastati...
Eligibility Criteria
Inclusion
- Measurable (per RECIST v1.1 criteria), metastatic prostate cancer.
- Refractory to approved standard systemic therapy.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Willing to sign a Durable Power of Attorney Form.
- Willing to practice birth control from the time of enrollment on this study and for four months after treatment.
- Subject must be co-enrolled on protocol 03-C-0277.
Exclusion
- Not applicable.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04135092
Last Update
September 4 2020
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