Prostate CancerPhase 1NCT01140373
Adoptive Transfer of Autologous T Cells Targeted to Prostate Specific Membrane Antigen (PSMA) for the Treatment of Castrate Metastatic Prostate Cancer (CMPC)
A Phase 1 study testing engineered autologous T cells and cyclophosphamide in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This is a phase I study which will test the safety of different doses of the patients own immune cells which have been changed to help recognize and destroy the cancer cells. The investigators want to find out what effects, good and/or bad, it has on the body and on the 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?
- engineered autologous T cells and cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Male, over 18 years of age
- Karnofsky Performance Scale (KPS) greater or = to 70%
- Histologic confirmation of prostate cancer at Memorial Sloan-Kettering Cancer Center (MSKCC)
- A diagnosis of progressive castrate metastatic prostate cancer defined as one or more of the following three criteria:
- Soft tissue progression defined by RECIST 1.0
- Bone disease progression defined by PCWG2 with two or more new lesions on bone scan
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- Post-hormonal therapy rising PSA values from a hormone therapy nadir on greater or = to 3 successive determinations at least two weeks apart, where the increase above the nadir is the greater of greater or = to 2.0 ng/mL or a greater or = to 10% change (Subjects with a rise in PSA but no evidence of metastases at any time by imaging studies will NOT be eligible.)
- For subjects who have discontinued anti-androgen therapy, PSA rise as defined above must be documented:
- Within two weeks after discontinuation if used following surgical or medical castration (second line therapy)
- After four weeks discontinuation if used as first line therapy.
- Evidence of metastatic disease in bone on bone scan, CT scan, and/or by MRI atany time following the initial diagnosis of prostate cancer.
- Castrate level of serum testosterone (<50 ng/mL) achieved by prior hormonal therapy consisting of either a) orchiectomy or b) luteinizing hormone-releasing hormone (LHRH) agonists with or without an anti-androgen
- Castrate level of serum testosterone (<50 ng/mL) achieved by prior hormonal therapy consisting of either a) orchiectomy or b) luteinizing hormone-releasing hormone (LHRH) agonists with or without an anti-androgen
- Lab requirements (Hematology):
- White blood count (WBC) ≥3,000/mm3
- Absolute neutrophil count ≥1,500/mm3
- Platelet ≥100,000/ mm3
- Hemoglobin ≥10 gm/d
- Lab requirements (Serum Chemistry):
- Bilirubin <1.5 X ULN (the upper limit of normal) (Subjects with confirmed Gilbert's Disease as the cause of their elevated bilirubin are to be permitted.)
- Serum alanine aminotransferase/serum aspartate aminotransferase (ALT/AST) < 2.5 X ULN (the upper limit of normal)
- Serum creatinine <1.5 X ULN(the upper limit of normal)
- Negative screen for Human Immunodeficiency virus (HIV), Hepatitis B virus (HBV) antigen, and Hepatitis C virus (HCV). If testing was done within the past three months, there is no need to repeat testing, as long as documentation of results is provided to the study site. Subjects must receive counseling and sign a separate informed consent for HIV testing.
- Subjects and their partners of reproductive potential must agree to use an effective form of contraception during the period of drug administration and for four weeks following the completion of the last administration of the study drug. An effective form of contraception is defined as oral contraceptives plus one form of barrier method or double barrier methods (condom with spermicide or condom with diaphragm).
- Subjects must be able to understand the potential risks and benefits of the study, and be able to read and give written informed consent.
Who cannot join
- History of non-prostate, primary, malignant cancer, except for non-melanoma skin cancer within previous five years
- History of splenectomy
- Autoimmune- or Ab-mediated disease including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, temporal arteritis, and thyroiditis
- Clinically significant cardiac disease (New York Heart Association Class III/IV) or severe debilitating pulmonary disease
- Radiation therapy within four weeks prior to start of study treatment (Day -1)
- Patients may not have received more than one prior chemotherapy
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- The following medications within four weeks prior to start of study treatment (Week 1): systemically administered radiopharmaceuticals such as bone seeking isotopes (e.g., samarium-153 Lexidronam); hematopoietic growth factors other than erythropoietin; medroxyprogesterone as an appetite stimulant; or alternative medicine treatments for prostate cancer, including Prostasol (formerly: PC-Plus), saw palmetto, or Zyflamend®
- Active central nervous system (CNS) or symptomatic epidural metastatic disease
- An infection requiring antibiotic treatment within seven days of starting study treatment (Day -1)
- A requirement for daily systemic corticosteroids for any reason; or other immunosuppressive or immunomodulatory agents. Topical, nasal or physiologic corticosteroids are to be permitted.
- Administration of live attenuated vaccines within eight weeks of start of study treatment (Day -1) and throughout the study
- Administration of subunit or killed vaccines, such as influenza or pneumococcal vaccine, within two weeks prior to study treatment (Day-1) and throughout the study; EXCEPTION - Vaccination for influenza is permitted between Week 12 through Week 16 and after Week 20.
- Positive stool guaiac, excluding hemorrhoids or documented radiation-induced proctitis if test is performed at the discretion of the treating physician (stool guaiac test is not required to screen for eligibility).
- Any other medical condition that in the opinion of the Investigator may interfere with a subject's participation in, or compliance with, the study
- Participation in a therapeutic research study or receipt of an investigational drug within 4 weeks leukapheresis.
- Allergy to ganciclovir or acyclovir.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
This is a phase I study which will test the safety of different doses of the patients own immune cells which have been changed to help recognize and destroy the cancer cells. The investigators want to find out what effects, good and/or bad, it has on the body and on the prostate cancer. The immune cells (T cells) used in this study will be the patients own immune cells. They will be removed from the patients blood, changed in the laboratory, and then put back into their body. T cells help the body fight infections. These cells may also kill cancer cells in some cases. Right now the patients T cells are unable to kill the cancer cells. For this reason, the physician will change the T cells by putting in a gene so that they may be able to better recognize and kill the prostate cancer cells. A gene is a portion of information which comes from the DNA and tells the cell what to do. This gene will be put into the patients T cells by a weakened virus. It is hoped that this approach will help the T cells recognize the prostate cancer tumor cells and possibly kill them. The investigators have found that T cells modified in this way were able to cure a cancer similar to Chronic Lymphocytic Leukemia in mice. However, this is an entirely new treatment for prostate cancer and it is not known if it will have any beneficial or unexpected harmful effects.
- Conditions
- Prostate Cancer
- Being tested
- engineered autologous T cells, cyclophosphamide
- Keywords
- Prostate, Autologous T Cells, Castrate Metastatic Prostate Cancer, cyclophosphamide, 09-036
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
engineered autologous T cellsBiological
Three cohorts of patients each will receive escalating doses of transduced autologous chimeric T lymphocytes at 1 x 10^7 CAR+ T cells/kg, 3 x 10^7 CAR+ T cells/kg, and 1 x 108 CAR+ T cells/kg, respectively. One patient will be initially added to the three already enrolled in cohort 1 using a new variant vector expressing the P28z CAR, and up to three patients may be added to each cohort, for a total of up to six each, in the case of Grade 3 toxicity and/or sub-optimal imaging. A 4th cohort of three patients may be added if an anti-PSMA effect is observed either immunologically or radiographically or if there is preferential targeting of the cells at a particular dose level. The dose level of the 4th cohort would be from a previously tested dose level. All patients will receive one dose of cyclophosphamide (Cy) at 300mg/m2 iv one day prior to infusion of T cells.
cyclophosphamideDrug
Three cohorts of patients each will receive escalating doses of transduced autologous chimeric T lymphocytes at 1 x 10^7 CAR+ T cells/kg, 3 x 10^7 CAR+ T cells/kg, and 1 x 10^8 CAR+ T cells/kg, respectively. One patient will be initially added to the three already enrolled in cohort 1 using a new variant vector expressing the P28z CAR, and up to three patients may be added to each cohort, for a total of up to six each, in the case of Grade 3 toxicity and/or sub-optimal imaging. A 4th cohort of three patients may be added if an anti-PSMA effect is observed either immunologically or radiographically or if there is preferential targeting of the cells at a particular dose level. The dose level of the 4th cohort would be from a previously tested dose level. All patients will receive one dose of cyclophosphamide (Cy) at 300mg/m2 iv one day prior to infusion of T cells.
| Study group | Role | What they receive |
|---|---|---|
| autologous T cells & cyclophosphamide. | Experimental | This is a phase I dose escalation study to assess the safety and tolerability using increasing doses of engineered autologous T cells targeted to Prostate-Specific Membrane Antigen (PSMA) administered one day after pretreatment with cyclophosphamide. Receives: Biological: engineered autologous T cells; Drug: cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability of immunotherapy
Dose escalation is based on the dose limiting toxicity (DLT). In this phase I trial, dose escalation will be based on the DLT, defined as a grade 3 or 4 toxicity (excluding alopecia, fatigue) developing after infusion of the T cells as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Scale (CTCAE) Version 3.0. Only toxicities that are possibly, probably, or definitely related to treatment will be considered DLTs. Patients will be observed for DLTs four weeks (28 days) from the T cell infusion
Measured: 4 weeks
Secondary outcomes (6)
Changes in bone metastases
Measured: Week 12 then every 3 months
Changes in biomarkers of bone metastasis and metabolism
Measured: Week 4 and week 12
Changes in circulating tumor cells
Measured: Weeks 4, 12, 24 and every 3 months
Humoral and cell-mediated immunity to PSMA and other known prostate cancer antigens
Measured: Weeks 12 and 24
To assess patterns of change in PSA.
Measured: 5 years
To track the persistence, accumulation, and migration of genetically retargeted anti-PSMA autologous T cells
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
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.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Susan Slovin, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140373
- Sponsor's protocol ID
- 09-036
- Status last verified
- Jul 2026
- First submitted
- 7 Jun 2010
- Last updated
- 7 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adoptive Transfer of Autologous T Cells Targeted to Prostate Specific Membrane Antigen (PSMA) for the Treatment of Castrate Metastatic Prostate Cancer (CMPC)
- ClinicalTrials.gov ID
- NCT01140373
- Acronym / sponsor ID
- 09-036
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Autologous T Cells, Castrate Metastatic Prostate Cancer, cyclophosphamide, 09-036
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Jun 2010
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Jun 2010 (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 is a phase I study which will test the safety of different doses of the patients own immune cells which have been changed to help recognize and destroy the cancer cells. The investigators want to find out what effects, good and/or bad, it has on the body and on the prostate cancer. The immune cells (T cells) used in this study will be the patients own immune cells. They will be removed from the patients blood, changed in the laboratory, and then put back into their body. T cells help the body fight infections. These cells may also kill cancer cells in some cases. Right now the patients T cells are unable to kill the cancer cells. For this reason, the physician will change the T cells by putting in a gene so that they may be able to better recognize and kill the prostate cancer cells. A gene is a portion of information which comes from the DNA and tells the cell what to do. This gene will be put into the patients T cells by a weakened virus. It is hoped that this approach will help the T cells recognize the prostate cancer tumor cells and possibly kill them. The investigators have found that T cells modified in this way were able to cure a cancer similar to Chronic Lymphocytic Leukemia in mice. However, this is an entirely new treatment for prostate cancer and it is not known if it will have any beneficial or unexpected harmful effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autologous T cells & cyclophosphamide. | Experimental | Biological: engineered autologous T cells, Drug: cyclophosphamideThis is a phase I dose escalation study to assess the safety and tolerability using increasing doses of engineered autologous T cells targeted to Prostate-Specific Membrane Antigen (PSMA) administered one day after pretreatment with cyclophosphamide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Male, over 18 years of age
- Karnofsky Performance Scale (KPS) greater or = to 70%
- Histologic confirmation of prostate cancer at Memorial Sloan-Kettering Cancer Center (MSKCC)
- A diagnosis of progressive castrate metastatic prostate cancer defined as one or more of the following three criteria:
- Soft tissue progression defined by RECIST 1.0
Key exclusion criteria (16 listed)
- History of non-prostate, primary, malignant cancer, except for non-melanoma skin cancer within previous five years
- History of splenectomy
- Autoimmune- or Ab-mediated disease including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, temporal arteritis, and thyroiditis
- Clinically significant cardiac disease (New York Heart Association Class III/IV) or severe debilitating pulmonary disease
- Radiation therapy within four weeks prior to start of study treatment (Day -1)
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 |
|---|---|---|
| engineered autologous T cellsThree cohorts of patients each will receive escalating doses of transduced autologous chimeric T lymphocytes at 1 x 10^7 CAR+ T cells/kg, 3 x 10^7 CAR+ T cells/kg, and 1 x 108 CAR+ T cells/kg, respectively. One patient will be initially added to the three already enrolled in cohort 1 using a new variant vector expressing the P28z CAR, and up to three patients may be added to each cohort, for a total of up to six each, in the case of Grade 3 toxicity and/or sub-optimal imaging. A 4th cohort of three patients may be added if an anti-PSMA effect is observed either immunologically or radiographically or if there is preferential targeting of the cells at a particular dose level. The dose level of the 4th cohort would be from a previously tested dose level. All patients will receive one dose of cyclophosphamide (Cy) at 300mg/m2 iv one day prior to infusion of T cells. | Biological | autologous T cells & cyclophosphamide. |
| cyclophosphamideThree cohorts of patients each will receive escalating doses of transduced autologous chimeric T lymphocytes at 1 x 10^7 CAR+ T cells/kg, 3 x 10^7 CAR+ T cells/kg, and 1 x 10^8 CAR+ T cells/kg, respectively. One patient will be initially added to the three already enrolled in cohort 1 using a new variant vector expressing the P28z CAR, and up to three patients may be added to each cohort, for a total of up to six each, in the case of Grade 3 toxicity and/or sub-optimal imaging. A 4th cohort of three patients may be added if an anti-PSMA effect is observed either immunologically or radiographically or if there is preferential targeting of the cells at a particular dose level. The dose level of the 4th cohort would be from a previously tested dose level. All patients will receive one dose of cyclophosphamide (Cy) at 300mg/m2 iv one day prior to infusion of T cells. | Drug | autologous T cells & cyclophosphamide. |
Primary outcome
The safety and tolerability of immunotherapy
Time frame: 4 weeks
Dose escalation is based on the dose limiting toxicity (DLT). In this phase I trial, dose escalation will be based on the DLT, defined as a grade 3 or 4 toxicity (excluding alopecia, fatigue) developing after infusion of the T cells as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Scale (CTCAE) Version 3.0. Only toxicities that are possibly, probably, or definitely related to treatment will be considered DLTs. Patients will be observed for DLTs four weeks (28 days) from the T cell infusion
6 secondary outcomes
Changes in bone metastases
Time frame: Week 12 then every 3 months
Changes in biomarkers of bone metastasis and metabolism
Time frame: Week 4 and week 12
Changes in circulating tumor cells
Time frame: Weeks 4, 12, 24 and every 3 months
Humoral and cell-mediated immunity to PSMA and other known prostate cancer antigens
Time frame: Weeks 12 and 24
To assess patterns of change in PSA.
Time frame: 5 years
To track the persistence, accumulation, and migration of genetically retargeted anti-PSMA autologous T cells
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Susan Slovin, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
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 engineered autologous T cells and cyclophosphamide in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer 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 25 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
The safety and tolerability of immunotherapy (time frame: 4 weeks). 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 7 Jul 2026.