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

NCT ID: NCT04194190

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

Brief Summary

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

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 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.

Interventions

Individual Patient TCR-Transduced PBL

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

209956

Identifier Type: OTHER

Identifier Source: secondary_id

20-C-9956

Identifier Type: -

Identifier Source: org_study_id