SYNC-T Therapy for Prostate Cancer

Recruiting at 2 trial locations

Overseen By Central Contact

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Syncromune, Inc.

Must not be taking: Anticoagulants, Blood thinners

Disqualifiers: Other malignancy, Cardiac illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

70 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants receiving bone resorptive therapy must be on stable doses for at least 42 days before starting the trial. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the SYNC-T Therapy for Prostate Cancer treatment SV-102?

The research on sipuleucel-T, a similar immunotherapy, shows it can improve survival in men with advanced prostate cancer by about 4 months compared to a placebo. This suggests that treatments like SV-102, which may have similar mechanisms, could also be effective in prolonging survival. ^{1 2 3 4 5}

Is SYNC-T Therapy (also known as SV-102) safe for humans?

The treatment, known as sipuleucel-T, has been tested in several studies for prostate cancer and is generally considered safe, with most side effects being mild to moderate, like flu-like symptoms such as chills and fatigue, which usually resolve within a couple of days. ^{2 6 7 8 9}

How does the SYNC-T Therapy for Prostate Cancer differ from other treatments?

SYNC-T Therapy, involving the treatment SV-102, is unique because it is an autologous cellular immunotherapy, meaning it uses a patient's own immune cells to fight prostate cancer. This approach is different from traditional treatments like hormone therapy or chemotherapy, as it specifically stimulates the immune system to target cancer cells, potentially offering a better safety profile and the ability to combine with other therapies. ^{2 6 10 11 12}

What is the purpose of this trial?

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.

Research Team

Charles J Link, MD

Principal Investigator

Syncromune, Inc.

Eligibility Criteria

Men over 18 with advanced prostate cancer that's resistant to castration and has progressed after certain therapies, or when no other standard treatments are available. Participants must have low testosterone if on hormone therapy, be able to handle anesthesia, and have a life expectancy of at least 6 months.

Inclusion Criteria

I have recovered from all side effects of my previous cancer treatments, except for hair loss.

I can sign and follow the study's requirements.

My prostate cancer is advanced, can be measured, and confirmed by tests.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive partial oncolysis plus an intratumoral infusion of SV-102 at escalating doses to determine the maximum tolerated dose (MTD)

Up to 48 weeks

Dose Expansion

Participants receive partial oncolysis plus an intratumoral infusion of SV-102 at the recommended phase 2 dose (RP2D) determined from the dose escalation phase

Up to 48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including overall survival and progression-free survival

Up to 2 years

Treatment Details

Interventions

• SV-102

Trial Overview The trial is testing the safety and tolerability of a new therapy called SV-102 for prostate cancer. It aims to find the highest dose patients can take without serious side effects (MTD) or decide on a dose for future studies.

Participant Groups

Group I: Part 2 - Dose Optimization, Arm 2: Partial Oncolysis + SV-102 Experimental Treatment 2 Interventions

Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, dose level selected from Part 1.

Group II: Part 2 - Dose Optimization, Arm 1: Partial Oncolysis + SV-102 Experimental Treatment 2 Interventions

Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, dose level selected from Part 1.

Group III: Part 1 - Dose Escalation, Cohort 3: Partial Oncolysis + SV-102 Experimental Treatment 2 Interventions

Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, Dose Level 3.

Group IV: Part 1 - Dose Escalation, Cohort 2: Partial Oncolysis + SV-102 Experimental Treatment 2 Interventions

Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, Dose Level 2.

Group V: Part 1 - Dose Escalation, Cohort 1: Partial Oncolysis + SV-102 Experimental Treatment 2 Interventions

Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, Dose Level 1.

Who Is Running the Clinical Trial?

Syncromune, Inc.

Lead Sponsor

Trials

3

Recruited

110+

Findings from Research

Sipuleucel-T (Provenge) has been shown to provide a significant survival benefit for men with metastatic castration-resistant prostate cancer, improving median survival by 4.1 months compared to placebo (25.8 vs 21.7 months) in a Phase III trial involving 512 patients.

The treatment has a favorable toxicity profile and manageable administration, making it a promising option to combine with other standard therapies for prostate cancer, potentially enhancing overall treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sipuleucel-T for prostate cancer: the immunotherapy era has commenced. Buonerba, C., Ferro, M., Di Lorenzo, G.[2016]

Sipuleucel-T is an autologous cellular immunotherapy that effectively stimulates the immune system to target prostate cancer, leading to prolonged overall survival in men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (CRPC).

The findings from phase III studies highlight the efficacy and safety of sipuleucel-T, suggesting its important role in the treatment of advanced prostate cancer and indicating potential directions for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sipuleucel-T for the treatment of advanced prostate cancer. Frohlich, MW.[2016]

In a phase III trial involving 950 patients with metastatic castrate-refractory prostate cancer, oral satraplatin significantly reduced the risk of disease progression or death by 33% compared to placebo, indicating its efficacy in delaying disease progression.

While satraplatin did not improve overall survival compared to placebo, it effectively delayed pain progression and was generally well tolerated, although some patients experienced more frequent side effects like myelosuppression and gastrointestinal disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multinational, double-blind, phase III study of prednisone and either satraplatin or placebo in patients with castrate-refractory prostate cancer progressing after prior chemotherapy: the SPARC trial. Sternberg, CN., Petrylak, DP., Sartor, O., et al.[2022]

In a study of 94 men with metastatic castration-resistant prostate cancer (mCRPC) treated with sipuleucel-T, the median overall survival (OS) was found to be 34.9 months, indicating a significant survival benefit from this immunotherapy.

Key factors influencing OS included the patient's performance status, the rate of PSA doubling time, and prior treatment with other therapies like abiraterone or enzalutamide, suggesting that these factors should be considered when selecting patients for sipuleucel-T treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Variables Associated With Overall Survival in Metastatic Castration-Resistant Prostate Cancer Patients Treated With Sipuleucel-T Immunotherapy. Wei, XX., Perry, J., Chang, E., et al.[2022]

Sipuleucel-T is the first autologous cellular therapy shown to be safe and to improve overall survival in patients with asymptomatic or minimally symptomatic castration-resistant prostate cancer (CRPC).

There is potential for enhancing the efficacy of sipuleucel-T by combining it with other treatments like checkpoint inhibitors, cytokines, or chemotherapy, which could lead to better outcomes in immunotherapy for solid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapeutic approaches in prostate cancer: combinations and clinical integration. Slovin, SF.[2018]

Sipuleucel-T (Provenge) is the first approved autologous therapeutic cancer vaccine for men with asymptomatic or minimally symptomatic castrate-resistant metastatic prostate cancer, demonstrating a significant median survival increase of 4.1 months and a 22.5% reduction in risk of death after three infusions.

The treatment has a favorable safety profile, with the most common side effects being flu-like symptoms, allowing for potential combination with other therapies and earlier use in the disease progression, maximizing therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sipuleucel-T (Provenge) autologous vaccine approved for treatment of men with asymptomatic or minimally symptomatic castrate-resistant metastatic prostate cancer. Gardner, TA., Elzey, BD., Hahn, NM.[2016]

In two clinical trials involving 225 men with advanced prostate cancer, sipuleucel-T treatment resulted in a 33% reduction in the risk of death compared to placebo, indicating a significant survival benefit.

The treatment was associated with mostly mild side effects, such as chills and headaches, suggesting that sipuleucel-T has a favorable risk-benefit profile for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer. Higano, CS., Schellhammer, PF., Small, EJ., et al.[2022]

Sipuleucel-T therapy for prostate cancer is generally safe, with most adverse events being mild to moderate and resolving within two days, including chills (53.1%) and pyrexia (31.3%).

There was no significant increase in serious adverse events or autoimmune complications compared to controls, indicating that sipuleucel-T can be administered safely in an outpatient setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated safety data from 4 randomized, double-blind, controlled trials of autologous cellular immunotherapy with sipuleucel-T in patients with prostate cancer. Hall, SJ., Klotz, L., Pantuck, AJ., et al.[2016]

Sipuleucel-T is the first FDA-approved autologous cellular immunotherapy for prostate cancer, designed to stimulate the immune system by using the patient's own cells to target a specific tumor-associated antigen, leading to a robust immune response.

In clinical studies, sipuleucel-T has shown a survival benefit for patients with metastatic castrate-resistant prostate cancer, with adverse events being mostly mild to moderate and comparable to those experienced by control subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of sipuleucel-T: autologous cellular immunotherapy for the treatment of metastatic castrate resistant prostate cancer. Sims, RB.[2016]

Sipuleucel T is an autologous cellular immunotherapy that effectively stimulates the immune system in men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer.

This treatment has been shown to improve overall survival, offering a valuable option for patients who have limited treatment alternatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sipuleucel-T: autologous cellular immunotherapy for men with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. Sims, RB.[2021]

Sipuleucel-T is an FDA-approved autologous cell immunotherapy specifically designed for treating castrate-refractory prostate cancer, particularly in patients who are asymptomatic or have minimal symptoms.

The review highlights that while sipuleucel-T can lead to clinical benefits, including potential survival advantages, these benefits may not always correlate with changes in prostate-specific antigen (PSA) levels, indicating a unique mechanism of action in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sipuleucel-T for therapy of asymptomatic or minimally symptomatic, castrate-refractory prostate cancer: an update and perspective among other treatments. Gupta, S., Carballido, E., Fishman, M.[2021]

Sipuleucel-T is an innovative immunotherapy that uses a patient's own dendritic cells to target prostate cancer, showing promising results in reducing prostate-specific antigen levels and extending the time before these levels double in men with biochemically relapsed prostate cancer.

In Phase III trials, sipuleucel-T significantly improved median overall survival in men with asymptomatic, metastatic hormone-refractory prostate cancer compared to placebo, indicating its potential as an effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sipuleucel-T (APC8015) for prostate cancer. So-Rosillo, R., Small, EJ.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Sipuleucel-T for prostate cancer: the immunotherapy era has commenced. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Sipuleucel-T for the treatment of advanced prostate cancer. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Multinational, double-blind, phase III study of prednisone and either satraplatin or placebo in patients with castrate-refractory prostate cancer progressing after prior chemotherapy: the SPARC trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical Variables Associated With Overall Survival in Metastatic Castration-Resistant Prostate Cancer Patients Treated With Sipuleucel-T Immunotherapy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Immunotherapeutic approaches in prostate cancer: combinations and clinical integration. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Sipuleucel-T (Provenge) autologous vaccine approved for treatment of men with asymptomatic or minimally symptomatic castrate-resistant metastatic prostate cancer. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Integrated safety data from 4 randomized, double-blind, controlled trials of autologous cellular immunotherapy with sipuleucel-T in patients with prostate cancer. [2016]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Development of sipuleucel-T: autologous cellular immunotherapy for the treatment of metastatic castrate resistant prostate cancer. [2016]

10. Australia pubmed.ncbi.nlm.nih.gov

Sipuleucel-T: autologous cellular immunotherapy for men with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. [2021]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Sipuleucel-T for therapy of asymptomatic or minimally symptomatic, castrate-refractory prostate cancer: an update and perspective among other treatments. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Sipuleucel-T (APC8015) for prostate cancer. [2022]