Actively Recruiting
A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer
Led by Syncromune, Inc. · Updated on 2026-02-27
70
Participants Needed
9
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of SYNC-T Therapy SV-102 and to identify the maximum tolerated dose (MTD) and/or selected dose for phase 2b study.
CONDITIONS
Official Title
A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 years or older
- Able to provide written informed consent and follow study procedures
- Advanced or metastatic prostate adenocarcinoma confirmed by biopsy, excluding small cell histology
- Serum testosterone \u22640.5 ng/mL if on anti-hormonal therapy
- Disease progression after at least one approved second-generation androgen-receptor-pathway inhibitor, with or without prior taxane therapy
- No more than three prior lines of therapy
- Able to undergo general anesthesia or conscious sedation
- Cardiac clearance obtained within 2 months before first treatment
- Eastern Cooperative Oncology Group (ECOG) performance status less than 3
- Life expectancy of at least 6 months
- Last dose of previous anticancer therapy (except hormonal therapy) at least 28 days before first study treatment
- Resolution of all acute toxic effects of prior anticancer therapy, except alopecia
- For males with female partners of childbearing potential, agreement to use effective contraception or true abstinence during treatment and up to 120-150 days after last dose
- At least one measurable tumor lesion accessible for biopsy and infusion, meeting size and location requirements
- Stable bone resorptive therapy for at least 42 days before treatment
- No other meaningful life-prolonging therapy options available or participant refuses other therapy
- Adequate bone marrow, kidney, and liver function
- Willing to provide tumor tissue and undergo on-treatment biopsy
You will not qualify if you...
- Other progressing primary cancers requiring treatment in last 3 years, except certain skin, thyroid, and breast cancers
- Obstructed urinary system before or after stenting
- Major surgery, including prostate interventions (except biopsy), within 28 days before treatment without adequate recovery
- Use of anticoagulants or blood thinners within protocol timelines
- Active infections requiring systemic therapy
- History of non-infectious pneumonitis requiring steroids
- Live vaccine within 30 days before enrollment
- Participation in other investigational drug or device studies within 28 days before treatment
- Significant cardiac or medical illnesses such as severe heart failure or unstable angina
- QTcF interval greater than 470 msec on ECG
- Malignant pleural effusions or ascites needing intervention
- Brain metastases history
- Certain autoimmune diseases, uncontrolled diabetes, cardiac arrhythmias, hypersensitivity, or other conditions deemed unsuitable
- History of bone marrow or stem cell transplant
- HIV/AIDS infection
- Active COVID-19 infection or positive test near treatment day
- Active viral hepatitis infections
- Liver complications including decompensated failure or tumors near vital structures
- BRCA mutation positive participants who agree to PARP inhibitor therapy
- Conditions increasing risk of treatment toxicity or interfering with study compliance
- Known visceral metastases
- Substance abuse or psychological/social conditions interfering with participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
University of Arizona Cancer Center
Tucson, Arizona, United States, 85719
Actively Recruiting
2
Duly Health
Lisle, Illinois, United States, 60532
Actively Recruiting
3
Wichita Urology
Wichita, Kansas, United States, 67226
Actively Recruiting
4
Michigan Institute of Urology
Troy, Michigan, United States, 48084
Actively Recruiting
5
Mercy Hospital
St Louis, Missouri, United States, 63141
Actively Recruiting
6
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68105
Actively Recruiting
7
Northwell Health
Lake Success, New York, United States, 11042
Actively Recruiting
8
Weill Cornell
New York, New York, United States, 10065
Actively Recruiting
9
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
C
Central Contact
CONTACT
W
www.legion100trial.com
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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