Scientists reprogram immune cells to attack prostate cancer
NCT ID NCT01140373
First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times
Summary
This early-stage trial tests whether a patient's own immune cells can be genetically modified to recognize and attack prostate cancer cells. Thirteen men with advanced prostate cancer that no longer responds to hormone therapy will receive infusions of their own engineered T cells. The main goal is to check safety and find the right dose.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- engineered autologous T cells (CAR-T cells targeting PSMA)
- What this could lead to
- If it works, this could point toward a new treatment for advanced prostate cancer that uses the patient's own immune system.
- What could go wrong
- This is a very early phase 1 trial with only 13 participants, so it is primarily testing safety, not effectiveness. The treatment may cause serious side effects or fail to shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
13 people
The number who actually took part.
- Start date
-
Jun 2010
- Expected to finish
-
Jun 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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 * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Castrate metastatic prostate cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Radioactive missile aims at prostate cancer that spread
- New PET tracer targets ACP3 to spot prostate cancer
- Can a One-Week radiation course match four weeks for prostate cancer?
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains