Autologous Gamma Delta T Cells for Metastatic Castration-Resistant Prostate Cancer
This study is testing a new treatment called MSGV1-PSCA-8T28Z for men with metastatic castration-resistant prostate cancer (mCRPC). This is a type of prostate cancer that has spread and no longer responds to standard hormone therapy. MSGV1-PSCA-8T28Z uses your own immune cells (gamma delta T cells) that are specially modified to find and fight cancer cells. Before receiving these modified cells, you would also receive two chemotherapy drugs, Fludarabine and Cyclophosphamide. The main goal of this study is to find the safest dose of MSGV1-PSCA-8T28Z. You may be able to join if you are a man aged 18 or older with mCRPC that has spread to your bones, has gotten worse on imaging, and you have already tried at least one chemotherapy and one newer hormone therapy. This study is currently unclear on its recruitment status and plans to enroll 30 participants.
- Study design
- This is a Phase 1, single-center study that will enroll 30 participants. It includes a dose-escalation phase to find the safest dose and a dose-expansion phase to further evaluate the treatment.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The maximum tolerated dose will be measured up to 30 days after the cell transplant.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06193486
Autologous Gamma Delta T Cells to Target Prostate Stem Cell Antigen in mCRPC
Recruiting
PHASE1Ages 18+InterventionalTreatmentH. Lee Moffitt Cancer Center and Research InstituteInvestigator-initiated
~30 participants
Updated 2026-03-31 on ClinicalTrials.gov
What's tested:MSGV1-PSCA-8T28ZFludarabineCyclophosphamide
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MTD) of MSGV1-PSCA-8T28Z
Measured over Up to 30 days post transplant
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- Jingsong Zhang, MD, PhD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center
- Daniel Abate-Daga, PhD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer 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
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
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.
What this trial measures
- Maximum Tolerated Dose (MTD) of MSGV1-PSCA-8T28ZUp to 30 days post transplant
MTD of MSGV1-PSCA-8T28Z based on Dose Limiting Toxicity (DLT) in patients with Metastatic Castration-Resistant Prostate Cancer.