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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. Identifier: NCT04194190
Expanded Access Status : No longer available
First Posted : December 11, 2019
Last Update Posted : September 4, 2020
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

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

Drug: Individual Patient TCR-Transduced PBL

Detailed Description:


-Please refer to National Cancer Institute Surgery Branch (NCI-SB) protocol 18-C-0049, Amendment F.


-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.


  • 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.


  • 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.

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
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

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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult

Inclusion Criteria:


Exclusion Criteria:


No Contacts or Locations Provided
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Responsible Party: National Institutes of Health Clinical Center (CC) Identifier: NCT04194190    
Other Study ID Numbers: 20-C-9956
209956 ( Other Identifier: NIHCC )
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020