A Single Patient Will be Treated With Individual Patient TCR-Transduced PBL

National Institutes of Health Clinical Center (CC)

Status

Treatments: Drug: Individual Patient TCR-Transduced PBL

Study type: Expanded Access

Funder types: NIH

Identifiers

NCT04194190

209956 (Other Identifier)

20-C-9956

Details and patient eligibility

About

A single patient will be treated with Individual Patient TCR-Transduced PBL

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 breast cancer with autologous peripheral blood lymphocytes (PBL) that have been transduced with genes encoding T-cell receptors that recognize mutated neoantigens 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

Exclusion criteria