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

Single Patient Expanded Access

Study Overview

• Status: No longer available
• Intervention / Treatment: Drug: Cyclophosphamide; Biological: Individual Patient TCR Transduced PBL; Drug: Fludarabine; Drug: Aldesleukin; Drug: Pembrolizumab

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 Type: Expanded Access
• Expanded Access Type: Individual Patients

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: National Institutes of Health Clinical Center (CC)

Study record dates

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Immunological; Aldesleukin; Cyclophosphamide; Pembrolizumab; Fludarabine
• Other Study ID Numbers: 209950