Clinical trialNCT04135092
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
A study testing Individual Patient TCR Transduced PBL, Cyclophosphamide and Fludarabine, run by National Institutes of Health Clinical Center (CC).
Trial summary
Single Patient Expanded Access Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Individual Patient TCR Transduced PBL, Cyclophosphamide and Fludarabine
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Not applicable.
About this study
Single Patient Expanded Access
Read the 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.
- Being tested
- Individual Patient TCR Transduced PBL, Cyclophosphamide, Fludarabine, Aldesleukin, Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Patient TCR Transduced PBLBiological
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).
CyclophosphamideDrug
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.
FludarabineDrug
Days -7 to -3: Fludarabine 25 mg/m2 /day IVPB daily over 30 minutes for 5 days.
AldesleukinDrug
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).
PembrolizumabDrug
Pembrolizumab 2 mg /kg IV over approximately 30 minutes on Day -2 and then every 3 weeks until time of disease progression.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135092
- Sponsor's protocol ID
- 209950
- Status last verified
- Sep 2020
- First submitted
- 21 Oct 2019
- Last updated
- 4 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04135092
- Acronym / sponsor ID
- 209950
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- First posted
- 22 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Not applicable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual Patient TCR Transduced PBLDay 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). | Biological | – |
| CyclophosphamideDays -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 | – |
| FludarabineDays -7 to -3: Fludarabine 25 mg/m2 /day IVPB daily over 30 minutes for 5 days. | Drug | – |
| AldesleukinAldesleukin 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 | – |
| PembrolizumabPembrolizumab 2 mg /kg IV over approximately 30 minutes on Day -2 and then every 3 weeks until time of disease progression. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Patient TCR Transduced PBL, Cyclophosphamide and Fludarabine, run by National Institutes of Health Clinical Center (CC).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.