Metastatic Castration-resistant Prostate CancerPhase 1NCT06193486
Autologous Gamma Delta T Cells to Target Prostate Stem Cell Antigen in mCRPC
A Phase 1 study testing MSGV1-PSCA-8T28Z, Fludarabine and Cyclophosphamide in people with Metastatic Castration-resistant Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- MSGV1-PSCA-8T28Z, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2024to 13 Dec 2033
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Gillian Zankel, 813-745-0876, ICETtrials@moffitt.org
Jingsong Zhang, MD, PhD
About this study
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
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.
- Being tested
- MSGV1-PSCA-8T28Z, Fludarabine, Cyclophosphamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSGV1-PSCA-8T28ZBiological
Autologous Gamma Delta T Cells Genetically Engineered with a Chimeric Receptor to Target the Prostate Stem Cell Antigen.
FludarabineDrug
Also called Fludara
Fludarabine is an antimetabolite given prior to lymphodepletion.
CyclophosphamideDrug
Cyclophosphamide is a nitrogen mustard-derivative, polyfunctional alkylating agent given prior to lymphodepletion.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Participants will undergo leukapheresis followed by lymphodepletion and infusion of MSGV1-PSCA-8T28Z. The lymphodepletion regimen includes cyclophosphamide (500 mg/m2) and fludarabine (30 mg/m2) administered over 3 days (Days -5, -4, -3). The standard "3+3" design will be used to guide dose escalation/de-escalation decisions based on the cumulative number of patients who experience a dose limiting toxicity (DLT) at the current dose. The first cohort of 3 patients will be treated at dose level 1.
The target maximum doses infused at each dose level is:
Dose Level 1: 1x10^5 cells/kg Dose Level 2: 3x10^5 cells/kg Dose Level 3: 1x10^6 cells/kg Dose Level 4: 3x10^6 cells/kg Dose Level 5: 1x10^6 cells/kg Receives: Biological: MSGV1-PSCA-8T28Z; Drug: Fludarabine; Drug: Cyclophosphamide |
| Dose Expansion | Experimental | Participants will undergo leukapheresis followed by lymphodepletion and infusion of MSGV1-PSCA-8T28Z. Lymphodepletion will include 3 days of treatment with fludarabine (30 mg/m^2) and cyclophosphamide (500 mg/m^2) prior to study day 0. Participants will then receive MSGV1-PSCA-8T28Z at the dose level determined to be the Maximum Tolerated Dose (MTD) in the dose escalation portion of the study. Receives: Biological: MSGV1-PSCA-8T28Z; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of MSGV1-PSCA-8T28Z
MTD of MSGV1-PSCA-8T28Z based on Dose Limiting Toxicity (DLT) in patients with Metastatic Castration-Resistant Prostate Cancer.
Measured: Up to 30 days post transplant
Secondary outcomes (3)
Best Prostate Specific Antigen (PSA) Response rate
Best PSA Response rate, which will be measured by percentage of patients who had 50% decline in PSA.
Measured: Up to 5 years
Radiographic progression-free survival (rPFS)
rPFS is defined as the duration of time from start of treatment to time of progression or death.
Measured: Up to 5 years
Percentage of circulating tumor cell count conversion from above 5/ml to below 5/ml.
The Circulating tumor cell conversion rate from above 5 to less than 5 will be used as a response criteria.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start26 Oct 2024
- Primary completion13 Jan 2029 (estimated)
- Study completion13 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingsong Zhang, MD, PhD, Principal investigator, Moffitt Cancer CenterDaniel Abate-Daga, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193486
- Sponsor's protocol ID
- MCC-22344
- Status last verified
- Mar 2026
- First submitted
- 21 Dec 2023
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06193486
- Acronym / sponsor ID
- MCC-22344
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 26 Oct 2024 (actual)
- Primary completion
- 13 Jan 2029 (estimated)
- Study completion
- 13 Dec 2033 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Biological: MSGV1-PSCA-8T28Z, Drug: Fludarabine, Drug: CyclophosphamideParticipants will undergo leukapheresis followed by lymphodepletion and infusion of MSGV1-PSCA-8T28Z. The lymphodepletion regimen includes cyclophosphamide (500 mg/m2) and fludarabine (30 mg/m2) administered over 3 days (Days -5, -4, -3). The standard "3+3" design will be used to guide dose escalation/de-escalation decisions based on the cumulative number of patients who experience a dose limiting toxicity (DLT) at the current dose. The first cohort of 3 patients will be treated at dose level 1. The target maximum doses infused at each dose level is: Dose Level 1: 1x10^5 cells/kg Dose Level 2: 3x10^5 cells/kg Dose Level 3: 1x10^6 cells/kg Dose Level 4: 3x10^6 cells/kg Dose Level 5: 1x10^6 cells/kg |
| Dose Expansion | Experimental | Biological: MSGV1-PSCA-8T28Z, Drug: Fludarabine, Drug: CyclophosphamideParticipants will undergo leukapheresis followed by lymphodepletion and infusion of MSGV1-PSCA-8T28Z. Lymphodepletion will include 3 days of treatment with fludarabine (30 mg/m^2) and cyclophosphamide (500 mg/m^2) prior to study day 0. Participants will then receive MSGV1-PSCA-8T28Z at the dose level determined to be the Maximum Tolerated Dose (MTD) in the dose escalation portion of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSGV1-PSCA-8T28ZAutologous Gamma Delta T Cells Genetically Engineered with a Chimeric Receptor to Target the Prostate Stem Cell Antigen. | Biological | Dose Escalation, Dose Expansion |
| FludarabineAlso: FludaraFludarabine is an antimetabolite given prior to lymphodepletion. | Drug | Dose Escalation, Dose Expansion |
| CyclophosphamideCyclophosphamide is a nitrogen mustard-derivative, polyfunctional alkylating agent given prior to lymphodepletion. | Drug | Dose Escalation, Dose Expansion |
Primary outcome
Maximum Tolerated Dose (MTD) of MSGV1-PSCA-8T28Z
Time frame: Up to 30 days post transplant
MTD of MSGV1-PSCA-8T28Z based on Dose Limiting Toxicity (DLT) in patients with Metastatic Castration-Resistant Prostate Cancer.
3 secondary outcomes
Best Prostate Specific Antigen (PSA) Response rate
Time frame: Up to 5 years
Radiographic progression-free survival (rPFS)
Time frame: Up to 5 years
Percentage of circulating tumor cell count conversion from above 5/ml to below 5/ml.
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Metastatic Castration-resistant Prostate Cancer
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NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jingsong Zhang, MD, PhD principal investigator
Moffitt Cancer Center
Daniel Abate-Daga, PhD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MSGV1-PSCA-8T28Z, Fludarabine and Cyclophosphamide in people with Metastatic Castration-resistant Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gillian Zankel (813-745-0876, ICETtrials@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of MSGV1-PSCA-8T28Z (time frame: Up to 30 days post transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.