Supercharged immune cells take on Hard-to-Treat prostate cancer
NCT ID NCT03873805
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests a new type of immunotherapy for men with advanced prostate cancer that no longer responds to hormone therapy. The treatment uses the patient's own immune cells, which are genetically modified in a lab to recognize and attack cancer cells that carry a protein called PSCA. The study involves 14 participants and aims to find the safest dose and understand side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PSCA-targeting CAR-T cells (engineered immune cells) and cyclophosphamide (chemotherapy)
- What this could lead to
- If it works, this could point toward a new treatment option for advanced prostate cancer that has stopped responding to hormone therapy.
- What could go wrong
- This is a very early Phase 1 trial with only 14 participants, focused on safety and dosing. The treatment may not shrink tumors or extend survival, and there are risks of serious side effects like cytokine release syndrome.
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
-
14 people
The number who actually took part.
- Started
-
Aug 2019
- Expected to finish
-
Mar 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: * All participants must have the ability to understand and the willingness to sign a written informed consent * Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 or KPS ≥70%. * Documented castration resistant prostate cancer (mCRPC) (Note: castration will be defined by a testosterone \< 50 ng/dL achieved by orchiectomy or luteinizing hormone-releasing hormone \[LHRH\] agonist/antagonist therapy) * Documented PSCA+ tumor expression as evaluated by City of Hope (COH) Pathology Care * Progression of disease manifest by one of the following means during treatment with at least one advanced androgen targeted therapy (e.g., abiraterone or enzalutamide) * Rising PSA documented on 2 occasions at least 7 days apart, with absolute increase \> 2 ng/dL despite testosterone \< 50 OR * Radiographic evidence of new metastatic foci on computed tomography (CT) or bone scan, or soft tissue progression by Response Evaluation Criteria in Solid Tumors (RECIST) * Prior chemotherapy with cabazitaxel and/or docetaxel is allowed but not required. If there has been prior chemotherapy, at least 2 weeks must have elapsed prior to leukapheresis * Prior radiotherapy is allowed provided it was not administered to the only evaluable site of disease and was \> 14 days prior to leukapheresis * No known contraindications to leukapheresis, steroids or tocilizumab * Total serum bilirubin =\< 2.0 mg/dL (to be performed within 42 days of signing the main study consent) * Patients with Gilbert syndrome may be included if their total bilirubin is =\< 3.0 x upper limit of normal (ULN) and direct bilirubin =\< 1.5 x ULN * Aspartate aminotransferase (AST) \< 5 x ULN (to be performed within 42 days of signing the main study consent) * Alanine aminotransferase (ALT) \< 5 x ULN (to be performed within 42 days of signing the main study consent) * Creatinine clearance of \>= 50 mL/min per the Cockcroft-Gault formula (to be performed within 42 days of signing the main study consent) * Cardiac function (12 lead-electrocardiography \[ECG\]) without acute abnormalities requiring investigation or intervention (to be performed within 42 days of signing the main study consent) * Left ventricular ejection fraction \> 40% (to be performed within 42 days of signing the main study consent) * Participants of reproductive potential must agree to use acceptable birth control methods throughout study therapy and for 3 months after final dose of study treatment Exclusion Criteria: * Participants with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of signing the main consent * Participants with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, including seizure disorder * History of allergic reactions attributed to compounds of similar chemical or biologic composition or other agents used in this study * Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia * History of stroke or intracranial hemorrhage within 6 months prior to signing the main consent * History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; non-muscle invasive bladder cancer; malignancy treated with curative intent with no known active disease present for \>= 3 years * Uncontrolled active infection * Active hepatitis B or hepatitis C infection * Human immunodeficiency virus (HIV) infection * Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Castration-resistant prostate carcinoma 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
-
City of Hope Medical Center
Duarte, California, 91010, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can engineered immune cells take down advanced prostate cancer?
- Can a Chemo-Targeted drug combo outsmart Treatment-Resistant prostate cancer?
- Can MRI-Guided radiation zero in on prostate tumors with fewer side effects?
- Can a tracer that hunts unstable iron light up hidden tumors?
- Can a three-drug cocktail outsmart resistant prostate cancer?
- Precision radiation may tame rising PSA after prostate surgery