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

National Institutes of Health Clinical Center (CC)

Status

Treatments: Biological: Individual Patient TCR Transduced PBL; Drug: Pembrolizumab; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Aldesleukin

Study type: Expanded Access

Funder types: NIH

Identifiers

NCT04135092

209950

Details and patient eligibility

About

Single Patient Expanded Access

Full 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.

Sex

Volunteers: No Healthy Volunteers

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.