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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| ClinicalTrials.gov Identifier: NCT04135092 |
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Expanded Access Status :
No longer available
First Posted : October 22, 2019
Last Update Posted : September 4, 2020
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Sponsor:
National Institutes of Health Clinical Center (CC)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
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Brief Summary:
Single Patient Expanded Access
| Intervention/treatment |
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| Biological: Individual Patient TCR Transduced PBL Drug: Cyclophosphamide Drug: Fludarabine Drug: Aldesleukin Drug: Pembrolizumab |
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 |
| 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 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Pembrolizumab
Intervention Details:
- Biological: Individual Patient TCR Transduced PBL
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).
- Drug: Cyclophosphamide
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.
- Drug: Fludarabine
Days -7 to -3: Fludarabine 25 mg/m2 /day IVPB daily over 30 minutes for 5 days.
- Drug: Aldesleukin
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).
- Drug: Pembrolizumab
Pembrolizumab 2 mg /kg IV over approximately 30 minutes on Day -2 and then every 3 weeks until time of disease progression.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
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.
No Contacts or Locations Provided
| Responsible Party: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT04135092 |
| Other Study ID Numbers: |
209950 |
| First Posted: | October 22, 2019 Key Record Dates |
| Last Update Posted: | September 4, 2020 |
| Last Verified: | September 2020 |
Additional relevant MeSH terms:
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Neoplasm Metastasis Neoplastic Processes Neoplasms Pathologic Processes Aldesleukin Cyclophosphamide Pembrolizumab Fludarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Immunological Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |