PSCA-Targeting CAR-T Cells for Metastatic Castration-Resistant Prostate Cancer
This study is testing a new treatment called Autologous Anti-PSCA-CAR-4-1BB/TCRzeta-CD19t-expressing T-lymphocytes (PSCA-CAR T cells), sometimes combined with radiation, for men with prostate cancer that has spread and is no longer responding to hormone therapy (metastatic castration-resistant prostate cancer). PSCA-CAR T cells are your own immune cells that are specially trained in a lab to find and fight cancer cells. Researchers want to see how safe this treatment is, what side effects it might cause, and if it can shrink tumors or lower PSA levels. The study plans to enroll 21 men. Success would mean fewer side effects and a 50% reduction in PSA levels.
- Study design
- This study is an interventional trial, meaning participants will receive a specific treatment. It aims to enroll 21 adult men.
- What's involved
- You would undergo procedures such as a tumor biopsy, bone scan, CT scan, and provide blood, stool, and urine samples. You would also undergo leukapheresis (a procedure to collect your T cells) and receive the PSCA-CAR T cells intravenously up to three times.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your health will be monitored for adverse events for up to 15 years after the CAR T cell infusion, and your PSA levels will be tracked for up to 1 year after treatment.
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NCT05805371
PSCA-Targeting CAR-T Cells Plus or Minus Radiation for the Treatment of Patients With PSCA+ Metastatic Castration-Resistant Prostate Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentCity of Hope Medical CenterInvestigator-initiated
~21 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Autologous Anti-PSCA-CAR-4-1BB/TCRzeta-CD19t-expressing T-lymphocytesBiopsyBiospecimen CollectionBone ScanComputed TomographyExternal Beam Radiation Therapy
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Post chimeric antigen receptor (CAR) T cell infusion up to 15 years
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Tanya B Dorff · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Documented informed consent of the participant and/or legally authorized representative (brown)
Assent, when appropriate, will be obtained per institutional guidelines
Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated main consent is processed. However, the research participant is allowed to proceed with lymphodepletion and CAR T cell infusion only after the translated main consent form is signed
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
If unavailable, exceptions may be granted with study principal investigator (PI) approval
Age: \>= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Karnofsky Performance Status (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 the COH Pathology Clinical Trials Specimen Qualification Laboratory (CTSQL)
Fresh or archival biopsy samples may be tested for PSCA expression during screening for eligibility purposes. The results from soft tissue biopsies will be used to confirm eligibility for participants who have a soft-tissue lesion biopsy obtained, but bone biopsy staining results will not impact eligibility since immunohistochemistry (IHC) staining for PSCA has not been optimized in bone specimens. Subjects who undergo bone biopsy on study will be qualified based on the archival tissue result
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 prostate specific antigen (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 CT or bone scan, or soft tissue progression by Response Evaluation Criteria in Solid Tumors (RECIST)
For treatment plan 2, subjects must have at least one and up to 3 metastatic lesions which have not previously been radiated and which is safe for treatment with radiation 16 gray (Gy) in 2 fractions
Fully recovered from the acute toxic effects (except alopecia) to =\< grade 1 to prior anti-cancer therapy
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 completed \> 14 days prior to leukapheresis
No known contraindications to leukapheresis, steroids or tocilizumab
Absolute neutrophil count (ANC) \>= 1,000/mm\^3 (within 42 days prior to enrollment)
NOTE: Growth factor is not permitted within 14 days of ANC assessment
Platelets \>= 100,000/mm\^3 (within 42 days prior to enrollment) NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment
Total serum bilirubin =\< 2.0 mg/dL (within 42 days prior to enrollment)
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) =\< 2.5 x ULN (within 42 days prior to enrollment)
Alanine aminotransferase (ALT) =\< 2.5 x ULN (within 42 days prior to enrollment)
Creatinine clearance of \>= 50 mL/min per 24 hour urine test or the Cockcroft-Gault formula (within 42 days prior to enrollment)
Corrected QT interval (QTc) =\< 480 ms
Note: to be performed within 28 days prior to day 1 of protocol therapy
Cardiac function (12 lead- electrocardiogram \[ECG\]) without acute abnormalities requiring investigation or intervention (within 42 days prior to enrollment)
Seronegative for human immunodeficiency virus (HIV) antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative), and syphilis (rapid plasma reagin \[RPR\])
If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed OR
If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable
Note infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy
Meets other institutional and federal requirements for infectious disease titer requirements
Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy
Agreement by males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy
Childbearing potential defined as not being surgically sterilized
Exclusion
Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. Physiologic replacement of steroids (prednisone =\< 7.5 mg /day, or hydrocortisone =\< 20 mg /day) is allowed
Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of screening
Subjects 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 to study agent
Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia
History of stroke or intracranial hemorrhage within 6 months prior to screening
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
Clinically significant uncontrolled illness
Active infection requiring antibiotics
Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection
Any other condition that would, in the Investigator's judgment, contraindicate the patient'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)
What this trial measures
- Incidence of adverse eventsPost chimeric antigen receptor (CAR) T cell infusion up to 15 years
Dose limiting toxicities (DLTs), cystitis, grade 3 toxicities and the full toxicity profile as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5 and cytokine release syndrome (CRS) and neurotoxicity as assessed by modified CRS grading. The recommended phase 2 dose (RP2D) will be based on the treatment plan 2 toxicity, activity and correlative data. Rates and associated 90% Clopper and Pearson binomial confidence limits will be estimated for DLTs within the DLT period. Tables will be created to summarize all toxicities and side effects by attribution to treatment arm, dose, organ and severity.
- 50% prostate specific antigen (PSA) level reductionFrom baseline measurement up to 1 year post study treatment
Statistical and graphical methods will be used to describe cytokine levels (peripheral blood) and PSA levels over the study period.