search
Back to results

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
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)

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

    First Posted
    October 21, 2019
    Last Updated
    September 3, 2020
    Sponsor
    National Institutes of Health Clinical Center (CC)
    search

    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
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    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

    We'll reach out to this number within 24 hrs