Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04194190
Expanded Access Status : No longer available
First Posted : December 11, 2019
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Tracking Information
First Submitted Date December 10, 2019
First Posted Date December 11, 2019
Last Update Posted Date September 4, 2020
 
Descriptive Information
Brief Title A Single Patient Will be Treated With Individual Patient TCR-Transduced PBL
Official Title 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
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.
Study Type Expanded Access
Expanded Access Type Individual Patients
Condition Not Provided
Intervention Drug: Individual Patient TCR-Transduced PBL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status No longer available
Eligibility Criteria

Inclusion Criteria:

-

Exclusion Criteria:

-

Sex/Gender Not Provided
Ages Child, Adult, Older Adult
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04194190
Other Study ID Numbers 20-C-9956
209956 ( Other Identifier: NIHCC )
Responsible Party National Institutes of Health Clinical Center (CC)
Study Sponsor National Institutes of Health Clinical Center (CC)
Collaborators Not Provided
Investigators Not Provided
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date September 2020