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
Primary Purpose
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Individual Patient TCR Transduced PBL
Cyclophosphamide
Fludarabine
Aldesleukin
Pembrolizumab
Sponsored by
About this trial
This is an expanded access trial
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT04135092
First Posted
October 21, 2019
Last Updated
September 3, 2020
Sponsor
National Institutes of Health Clinical Center (CC)
1. Study Identification
Unique Protocol Identification Number
NCT04135092
Brief 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
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
Study Type
Expanded Access
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institutes of Health Clinical Center (CC)
4. Oversight
5. Study Description
Brief Summary
Single Patient Expanded Access
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.
6. Conditions and Keywords
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Individual Patient TCR Transduced PBL
Intervention Description
Day 0: Cells will be infused at a dose not to exceed .5e11 in 400 mL IV on the Patient Care Unit over 20-30 minutes (2-4 days after the last dose of fludarabine).
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Days -7 and -6: Cyclophosphamide 60 mg/kg/day x 2 days IV in 250 mL D5W infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Days -7 to -3: Fludarabine 25 mg/m2 /day IVPB daily over 30 minutes for 5 days.
Intervention Type
Drug
Intervention Name(s)
Aldesleukin
Intervention Description
Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 10 doses).
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Pembrolizumab 2 mg /kg IV over approximately 30 minutes on Day -2 and then every 3 weeks until time of disease progression.
10. Eligibility
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
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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