Prostate CancerPhase 1NCT00664196
Trial of Anti-PSMA Designer T Cells in Advanced Prostate Cancer After Non-Myeloablative Conditioning
A Phase 1 study testing Gene Modified T Cells in people with Prostate Cancer, run by Roger Williams Medical Center at 1 site in United States.
Trial summary
This study tests the safety and tolerability of autologous anti-PSMA gene-modified T cells (designer T cells) in hormone refractory prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Gene Modified T Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Dec 2018
- Phase
- Phase 1
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of prostate cancer
- Elevated PSA
- Life expectancy > 4 months
- Performance status 0-1
- ANC 1.0
- Platelets > 100,000
Show all 14Show fewer
- Hemoglobin > 8.0
- Creatinine < 1.5mg/dl
- Direct Bilirubin < 1.5 mg/dl
- No evidence of CHF, CAD, cardiac arrhythmias, A-fib, A flutter, myocardial infarction.
- No serious, symptomatic obstructive or emphysematous lung disease
- No asthma requiring IV medication during last 12 months, no serious lung disease associated with dyspnea at normal activity levels, or at rest due to any cause, including cancer metastasis and pleural effusion
- Patients must have a biopsy able tumor, and be willing to undergo biopsy (Group 3 only)
- Patient is at least 18 years of age.
Who cannot join
- Serious or unstable renal, hepatic, pulmonary, cardiovascular, endocrine, rheumatologic or allergic disease based on history, labs or physical exam
- Active clinical disease caused by CMV, Hepatitis B, or C, HIV, TB
- Cytotoxic and/or radiation therapy during last 4 weeks prior to entry
- Any concurrent malignancies
- Patient requires systemic steroids
- Patient has participated in prior investigational therapy
- Patient has prior exposure to mouse antibody
- Patient has had irradiation to whole pelvis or >25% marrow
Trial locations and contacts
1 site in 1 country.
United States1 site
Roger Williams Medical Center
Providence, Rhode Island, 02908
About this study
Official title: Phase Ia/Ib Trial of Anti-PSMA Designer T Cells in Advanced Prostate Cancer After Non-Myeloablative Conditioning
This study tests the safety and tolerability of autologous anti-PSMA gene-modified T cells (designer T cells) in hormone refractory prostate cancer.
Read the detailed description
The study creates autologous gene-modified T cells against prostate specific membrane antigen (PSMA, unrelated to PSA) (designer T cells) by ex vivo modification of patient T cells. T cells are collected by leukopheresis, transported to the RWMC cGMP Cell Manipulation Core and transduced with retrovirus containing a chimeric antigen receptor (CAR) that is expressed on the modified cells. This CAR links specificity of an antibody against PSMA with signaling domains of the T cell and redirects the recognition of the T cells to engage and kill prostate cancer cells anywhere in the body. These are administered at a dose of 10^10 with randomization to either low or moderate Interleukin 2 given by CI (continuous infusion) for one month following the T cell infusion. Subsequent subjects will receive 10^11 cells with Interleukin 2 at either low or moderate dose, in a non randomized manner, depending upon the outcome of the prior cohort. Prior to T cell infusion, all subjects will receive non-myeloablative (NMA) conditioning. This conditioning creates a "space" in the blood and marrow for engraftment of the infused cells to maintain of high level of anti-tumor effector T cells in the body. Each patient is treated with a single dose of T cells, without repeat dosing. Patients are followed for toxicity and response and pharmacokinetics-pharmacodynamics of the infused T cells. Patients are on-study for one-month after their T cell dose.
- Conditions
- Prostate Cancer
- Being tested
- Gene Modified T Cells
- Keywords
- Prostate Cancer, T cells, Gene Transfer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene Modified T CellsBiological
Also called Designer T-Cells, PSMA, Hormone Refractory
One time infusion Modified T-Cells given through a vein in the arm or a catheter over a 30-60 minute period.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: Gene Modified T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety of using modified T cells by documenting the type and severity of any side effects and establishing the Maximum Tolerated Dose (MTD)
Measured: 1 Month
Secondary outcomes (3)
Tumor Response
Measured: 1 Month
Pharmacokinetics
Measured: 1 Month
Pharmacodynamics
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roger Williams Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard P Junghans, PhD, MD, Principal investigator, Roger Williams Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664196
- Sponsor's protocol ID
- 595-04
- Other IDs
- W81XWH-05-1-0408
- Status last verified
- Jun 2016
- First submitted
- 17 Apr 2008
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ia/Ib Trial of Anti-PSMA Designer T Cells in Advanced Prostate Cancer After Non-Myeloablative Conditioning
- ClinicalTrials.gov ID
- NCT00664196
- Acronym / sponsor ID
- 595-04
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, T cells, Gene Transfer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Funding
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Roger Williams Medical CenterUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 22 Apr 2008 (estimated)
- 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.
This study tests the safety and tolerability of autologous anti-PSMA gene-modified T cells (designer T cells) in hormone refractory prostate cancer.
Detailed description
The study creates autologous gene-modified T cells against prostate specific membrane antigen (PSMA, unrelated to PSA) (designer T cells) by ex vivo modification of patient T cells. T cells are collected by leukopheresis, transported to the RWMC cGMP Cell Manipulation Core and transduced with retrovirus containing a chimeric antigen receptor (CAR) that is expressed on the modified cells. This CAR links specificity of an antibody against PSMA with signaling domains of the T cell and redirects the recognition of the T cells to engage and kill prostate cancer cells anywhere in the body. These are administered at a dose of 10^10 with randomization to either low or moderate Interleukin 2 given by CI (continuous infusion) for one month following the T cell infusion. Subsequent subjects will receive 10^11 cells with Interleukin 2 at either low or moderate dose, in a non randomized manner, depending upon the outcome of the prior cohort. Prior to T cell infusion, all subjects will receive non-myeloablative (NMA) conditioning. This conditioning creates a "space" in the blood and marrow for engraftment of the infused cells to maintain of high level of anti-tumor effector T cells in the body. Each patient is treated with a single dose of T cells, without repeat dosing. Patients are followed for toxicity and response and pharmacokinetics-pharmacodynamics of the infused T cells. Patients are on-study for one-month after their T cell dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Gene Modified T Cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically confirmed diagnosis of prostate cancer
- Elevated PSA
- Life expectancy > 4 months
- Performance status 0-1
- ANC 1.0
Key exclusion criteria (8 listed)
- Serious or unstable renal, hepatic, pulmonary, cardiovascular, endocrine, rheumatologic or allergic disease based on history, labs or physical exam
- Active clinical disease caused by CMV, Hepatitis B, or C, HIV, TB
- Cytotoxic and/or radiation therapy during last 4 weeks prior to entry
- Any concurrent malignancies
- Patient requires systemic steroids
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 |
|---|---|---|
| Gene Modified T CellsAlso: Designer T-Cells, PSMA, Hormone RefractoryOne time infusion Modified T-Cells given through a vein in the arm or a catheter over a 30-60 minute period. | Biological | 1 |
Primary outcome
Determine the safety of using modified T cells by documenting the type and severity of any side effects and establishing the Maximum Tolerated Dose (MTD)
Time frame: 1 Month
3 secondary outcomes
Tumor Response
Time frame: 1 Month
Pharmacokinetics
Time frame: 1 Month
Pharmacodynamics
Time frame: 1 Month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
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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.
Richard P Junghans, PhD, MD principal investigator
Roger Williams Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gene Modified T Cells in people with Prostate Cancer, run by Roger Williams Medical Center at 1 site in United States.
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 14 inclusion and 8 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: paused, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Determine the safety of using modified T cells by documenting the type and severity of any side effects and establishing the Maximum Tolerated Dose (MTD) (time frame: 1 Month). It is what the study was designed to measure, not a finding.
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 17 Jun 2016.