Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

Autologous Gamma Delta T Cells to Target Prostate Stem Cell Antigen in mCRPC

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

Autologous Gamma Delta T Cells to Target Prostate Stem Cell Antigen in mCRPC (NCT06193486) is a Phase 1 interventional studying Metastatic Castration-resistant Prostate Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a phase 1 single center clinical trial for patients with end stage Metastatic Castration Resistant Prostate Cancer who have progressed through standard of care treatment options and are on zoledronate for bone metastases. This clinical trial includes a dose-escalation phase and dose-expansion phase to assess the safety and preliminary efficacy of treatment with autologous T cells genetically modified to express Prostate stem cell antigen.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Metastatic Castration-resistant Prostate Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. - expected to live at least 6 months. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BIOLOGICAL

MSGV1-PSCA-8T28Z

Autologous Gamma Delta T Cells Genetically Engineered with a Chimeric Receptor to Target the Prostate Stem Cell Antigen.

DRUG

Fludarabine

Fludarabine is an antimetabolite given prior to lymphodepletion.

DRUG

Cyclophosphamide

Cyclophosphamide is a nitrogen mustard-derivative, polyfunctional alkylating agent given prior to lymphodepletion.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Moffitt Cancer Center
Tampa, Florida, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06193486), the sponsor (H. Lee Moffitt Cancer Center and Research Institute), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06193486 clinical trial studying?

This is a phase 1 single center clinical trial for patients with end stage Metastatic Castration Resistant Prostate Cancer who have progressed through standard of care treatment options and are on zoledronate for bone metastases. This clinical trial includes a dose-escalation phase and dose-expansion phase to assess the safety and preliminary efficacy of treatment with autologous T cells genetically modified to express Prostate stem cell antigen. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06193486?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06193486?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06193486. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06193486. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.