Using modified T cells to target prostate cancer cells
Official title: A Phase I Clinical Trial of an Infusion of Autologous Gamma Delta T Cells Genetically Engineered With a Chimeric Receptor to Target the Prostate Stem Cell Antigen in Patients With Metastatic Castration Resistant Prostate Cancer
Run by H. Lee Moffitt Cancer Center and Research Institute · NCT06193486 · Data updated 2026-11-12
This study is testing a new treatment using modified T cells to see if it can help men with advanced prostate cancer who have run out of other options.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 30 (estimated) |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute Academic / other |
| Drugs / interventions | denosumab, CAR T, chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Tampa, Florida) |
| Status | Recruiting |
| Started | October 26, 2024 |
| Main results expected | January 13, 2029 |
| Study ends | December 13, 2033 |
| Registry record updated | March 31, 2026 |
| Trial ID | NCT06193486 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men with mCRPC who have previously received at least one line of chemotherapy and one androgen receptor-targeted therapy.
✕Probably not a fit
Patients who have not received prior chemotherapy or androgen receptor-targeted therapies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 1 clinical trial is designed for men with metastatic castration-resistant prostate cancer (mCRPC) who have exhausted standard treatment options and are currently receiving zoledronic acid for bone metastases. The trial involves a dose-escalation and dose-expansion phase to evaluate the safety and preliminary efficacy of autologous T cells that have been genetically modified to express prostate stem cell antigen. Participants will undergo lymphodepletion chemotherapy with fludarabine and cyclophosphamide before receiving the modified T cell therapy.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients with advanced prostate cancer who have limited treatment alternatives.
How similar studies have gone: While this approach is innovative, similar studies using genetically modified T cells for cancer treatment have shown promise, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men with metastatic castration-resistant prostate cancer (CRPC) to the bone with evidence of imaging progression based on the PCWG3 criteria. * Prior therapies with at least one line of chemotherapy and one new androgen receptor targeted therapy (abiraterone, enzalutamide, apalutamide, or darolutamide). * For patients who are on zoledronic acid a booster dose of zoledronic acid is required if the last dose of zoledronic acid is \>4 weeks prior to lymphodepletion chemo. If a patient is receiving denosumab, the next dose of denosumab needs to be changed to zoledronic acid and he needs to receive at least 1 dose of zoledronic acid prior to lymphodepletion chemotherapy. If a patient is not on zoledronic acid or denosumab, he needs to receive at least 2 doses of every 4 weeks of zoledronic acid prior to lymphodepletion chemotherapy. Zoledronic acid is recommended not to be resumed prior to week 8. After week 8, the resumption of zoledronic acid and the subsequent zoledronic acid treatment will be at the discretion of the treating physician. * No anticancer therapy (chemotherapy, biologic therapy, radiation or immunotherapy) in the 3 weeks before the T cell infusion (and all hematologic effects have resolved). No prior treatment with Radium 223 or Puvicto within 3 months of T cell infusion. No prior immunotherapy with checkpoint blockade (e.g., PD-1 inhibitor, PDL1 inhibitor, or CTL4- antagonist or similar agent) in the 6 months before the T cell infusion (and all clinically significant related side effects must be resolved). * Males age 18 years or older. * ECOG performance status less than or equal to 2 (or Karnofsky Performance Status greater than or equal to 70%). * Participants must have adequate organ and marrow function as defined by the protocol. * Life expectancy of at least 6 months. * The effects of CAR T cell infusion on the developing human fetus are unknown. Although patients who are eligible for this study will not have childbearing potential, any patient the treating doctor or investigator deems to have child fathering potential must agree to use adequate contraception from the time of screening to at least 6 months after administration of gamma delta enriched T cell infusion. Any female partner(s) with childbearing potential, of these participants, should also use adequate contraception during the same time period. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Known active hepatitis B infection, known history of hepatitis C or HIV infection. * Known dental issues like osteonecrosis of jaw that excludes the use of zoledronic acid * Any of the following cardiac conditions: Clinically significant heart disease (New York Heart Association class 3 or 4) or symptomatic congestive heart failure, Myocardial infarction less than 6 months before enrollment, History of clinically significant ventricular arrhythmia or unexplained syncope that is not believed to be vasovagal in nature or due to dehydration, History of severe non-ischemic cardiomyopathy with ejection fraction less than 20%, or Findings on baseline ECG or ECHO that, in the opinion of the patient's treating physician or investigator, would require medical intervention before anticancer therapy * Active autoimmune disease (excluding autoimmune thyroid disease on a stable thyroid regimen). Such conditions include but are not limited to systemic lupus erythematous, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and temporal arteritis. * Known or suspected leptomeningeal disease and patients with metastases to the brain stem, midbrain, pons, or medulla. * Known or suspected untreated brain metastases. Patients with radiographically stable, asymptomatic previously irradiated lesions are eligible provided patient is greater than 4 weeks beyond completion of cranial irradiation and greater than 3 weeks off of corticosteroid therapy at the time of study intervention. * Prior history of clinically significant seizure disorder (e.g., not including childhood febrile seizures). * Any concurrent active malignancies, defined as malignancies requiring any therapy other than expectant observation, because adverse events (AEs) resulting from these malignancies, or their treatment may confound our assessment of the safety of adoptive T cell therapy for ovarian cancer. * Any of the following within 28 days of first date of study treatment: Serious uncontrolled medical illness or disorder that in the opinion of the treating physician would make the patient ineligible for the study, or Active uncontrolled infection (with the exception of uncomplicated urinary tract infection) * Prior history of pancreatitis. * Any other issue which, in the opinion of the treating physician or principal investigator, would make the patient ineligible for the study.
Where it's running
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Moffitt Cancer Center
Tampa, Florida, United States Recruiting
Study contacts
- Principal investigator: Jingsong Zhang, MD, PhD — Moffitt Cancer Center
- Study coordinator: Gillian Zankel
- Email: ICETtrials@moffitt.org
- Phone: 813-745-0876
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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JUR-003 in adults with advanced prostate cancer
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SRT-017 radioligand therapy in PSMA-positive metastatic castration-resistant prostate cancer
This study tests SRT-017 given by IV infusion to men with PSMA-positive metastatic castration-resistant prostate cancer to see if it is safe and tolerable and to gather early signals of anti-tumor activity.
-
Rinzimetostat plus darolutamide in metastatic castration-resistant prostate cancer after abiraterone failure
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FX-111 safety and pharmacokinetics in metastatic castration-resistant prostate cancer
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Docetaxel and SX-682 in head and neck cancers and prostate cancer
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Dual-target PSMA/PSCA CAR-NK Therapy in Advanced Prostate Cancer
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.