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

• Registration Number: NCT04135092
• 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 metastatic prostate cancer with autologous peripheral blood lymphocytes (PBL) that have been transduced with genes encoding T-cell receptors that recognize the mutated TP53 shared oncogene in the autologous cancer.

Eligibility:

* Must have measurable, metastatic disease as assessed per RECIST v1.1 criteria.

* Must sign the informed consent document.

* Willing to sign Durable Power of Attorney Form.

* Must have all regulatory approvals prior to start of treatment.

Design:

* Please refer to NCI-SB protocol 18-C-0049, Amendment F.

* The patient will be treated with a non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine, followed by the infusion of autologous transduced PBL and then high-dose aldesleukin. The patient will also receive pembrolizumab on Day -2 prior to cell administration and additional doses every 3 weeks following cell infusion until the time of disease progression.

Study Timeline

• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-21
• Study First Posted: 2019-10-22
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-03
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

• 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 Criteria

Not applicable.

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified