A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer

Inclusion Criteria:

• Male >=18 years old.

• Able to provide written informed consent and comply with the study procedures.

• Participants with advanced and/or metastatic histologically or cytologicallyconfirmed adenocarcinoma of the prostate without small cell histology.

• Serum testosterone levels less than or equal to (<=) 0.5 nanograms per millilitre (ng/mL) (<=1.73 nanomoles per litre [nmol/L]) at screening if on anti-hormonaltherapy.

• Progression after the receipt of one or more approved second-generationandrogen-receptor-pathway inhibitors with or without a prior course of taxanetherapy, and those who have not responded or progressed after standard therapies orfor whom no further standard therapy exists or standard therapy is not available,and has not received more than three prior lines of therapy. If a poly adenosinediphosphate ribose (ADP)-ribose polymerase (PARP)-positive participants chose not toreceive an approved PARP-inhibitor they will be eligible for the study.

• Able to undergo general anesthesia or conscious sedation.

• Has undergone a cardiac work-up and received cardiac clearance within 2 monthsbefore first treatment.

• Eastern Cooperative Oncology Group (ECOG) performance status of less than (<) 3.

• Life expectancy >=6 months

• Last dose of previous anticancer therapy (excluding hormonal therapy) must by 28days or more prior to first study treatment.

• Resolution of all acute toxic effects (excluding alopecia) of any prior anticancertherapy.

• For males with female partners of childbearing potential, even if surgicallysterilized (that is [i.e.], status post vasectomy), who agree to practice:

1. effective barrier contraception during the treatment period and through 120-150days after last dose, OR

2. true abstinence, when this is in line with the preferred and usual lifestyle ofthe participants. Periodic abstinence (for example [e.g.], calendar, ovulation,symptothermal, post ovulation methods), withdrawal, spermicides only, andlactational amenorrhea are not acceptable methods of contraception. Female andmale condoms should not be used together.

• Has at least one lesion of at least 1 centimeter (cm), measurable in at least twodimensions within the prostate accessible transperineally using transrectalultrasound (TRUS) that is demonstrable on magnetic resonance imaging (MRI)/computedtomography (CT) and is accessible for infusion on TRUS or, if a radicalprostatectomy has been performed, has a metastatic lesion of at least 1 cm or lymphnode lesion of at least 1.5 cm, that is demonstrable on MRI/CT and accessible by apercutaneous needle to permit both tumor biopsy and immunotherapy infusion. Theeligible tumor lesion for intratumoral-infusion cannot be a tumor that is adjacentto vital structures such as major nerves or blood vessels or at risk of airwaycompromise in the event of post-infusion tumor swelling/inflammation.

• Participants receiving bone resorptive therapy must be on stable doses for at least 42 days prior to the oncolysis.

• In the opinion of the Investigator, there is no other meaningful life prolongingtherapy option available, or the participant refuses other therapy, outside ofanti-hormonal therapy.

• Adequate bone marrow, renal, and hepatic function.

• Participants agrees to provide tumor tissue and undergo an on-treatment tumorbiopsy.

Exclusion Criteria:

• Has a known other primary malignancy other than prostate cancer that is progressingor has required active treatment in the last 3 years, excluding basal and squamouscell carcinoma, papillary thyroid cancer, and ductal carcinoma in situ of thebreast.

• Has an obstructed urinary system before or after stenting.

• Has undergone major surgery, including local prostate intervention (excludingprostate biopsy), within 28 days prior to the first dose of study treatment and hasnot recovered adequately from the toxicities and/or complications.

• Has used any anticoagulants or other blood thinners pre-study treatments within theprotocol-defined timelines.

• Has an active infection (including tuberculosis) requiring systemic therapy.

• Has a history of non-infectious pneumonitis that requires steroids.

• Has received a live vaccine within 30 days prior to the enrollment.

• Is currently participating in or has participated in a study of an investigationalagent or has used an investigational device within 28 days prior to the first studytreatment.

• Significant cardiac or other medical illness such as severe congestive heartfailure, unstable angina, or serious cardiac arrhythmia (e.g., New York HeartAssociation Class 4), or history of previous heart failure.

• Fridericia corrected QT interval (QTcF) greater than (>) 470 millisecond (msec) (men) on a 12-lead electrocardiogram (ECG) during the screening period.

• Malignant pleural effusions or ascites that require immediate intervention.

• Brain metastases (includes history of).

• Prior history of autoimmune disease except hypothyroidism, uncontrolled or unmanageddiabetes (glycated haemoglobin [HbA1c] >=6.5), cardiac arrhythmia (unstable oruntreated), hypersensitivity, or other illness or disease that in the opinion of thePrincipal Investigator, with consultation with Syncromune's Chief Medical Officer,makes the participant a poor candidate.

• History of bone marrow/stem cell transplant.

• Participants having human immunodeficiency virus (HIV) infection or acquired immunedeficiency syndrome (AIDS) are not eligible for enrollment.

• Active coronavirus disease-2019 (COVID-19) infection or tests positive for COVID-19a day before or the day of planned study treatment.

• Participants who have active viral (any etiology) hepatitis are excluded.

• Participants with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen [HBsAg] test and a positivehepatitis B core antibody (anti-HBc) test) who have a viral load below the limitquantification (HBV deoxyribonucleic acid [DNA] titer <1000 copies per milliliters [cps/mL] or 200 international units per milliliter [IU/mL]) and are not currently onviral suppressive therapy may be eligible and should be discussed with the Sponsor'sMedical Monitor.

• Participants with a history of hepatitis C virus (HCV) infection should havecompleted curative antiviral treatment and have a viral load below the limit ofquantification are eligible for study entry. Known or suspected hepatitis Cinfection which has not been treated and cured are not eligible. Known or suspectedhepatitis C currently on treatment with an undetectable viral load are eligible.Patients with a history of hepatitis C virus (HCV) infection should have completedcurative antiviral treatment and have a viral load below the limit of quantificationare eligible for study entry.

• Participants with complications or contraindications related to the liver, includingintrahepatic biliary ductal dilation, uncorrectable bleeding diathesis, anddecompensated liver failure, tumor burden of over 5 lesions, tumors greater than 5cm in size, tumors in close proximity to vital structures, such as portal vein,biliary tree, or gastrointestinal tract.

• Breast cancer gene (BRCA) mutation testing will be required for participants notpreviously treated with a PARP inhibitor, unless BRCA status is established prior toscreening. If PARP-positive and participants agree to PARP therapy, they will beineligible.

• Any condition(s) that, in the opinion of the Investigator, would increase the riskfor toxicities from study treatment, or interfere with participants compliance orconduct of this study.

• Known visceral metastases.

• Known substance abuse or medical, psychological, or social conditions that mayinterfere with patient's participation.