Dendritic Cell Vaccine for Breast Cancer

Overseen By Neveen Abdo

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Immunosuppressants, Investigational agents

Disqualifiers: Metastatic cancer, Autoimmune disease, others

Stay on Your Current Meds You can continue your current medications while participating

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 3 years

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and immune response of a new personalized vaccine for breast cancer. The vaccine uses a patient's own tumor data to help the body fight remaining cancer cells after standard treatments. The trial seeks individuals with stage II-III breast cancer who have undergone chemotherapy and surgery but still have significant cancer tissue remaining. Participants should not have active metastatic disease and must have enough tumor tissue available for testing. As an Early Phase 1 trial, participants will be among the first to receive this innovative treatment, contributing to understanding its effects in people.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on investigational agents or systemic immunosuppressants, you may not be eligible to participate.

Is there any evidence suggesting that the Dendritic Cell Vaccine is likely to be safe for humans?

Research has shown that the dendritic cell (DC) vaccine is generally easy for patients to handle. Studies have found that in breast cancer patients, it does not cause serious side effects like chemotherapy or radiation. When combined with chemotherapy, the vaccine boosts the immune system's effectiveness. This combination has proven safe for patients. Evidence suggests that this vaccine is a promising and safe option for treating breast cancer without causing major side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for breast cancer, like chemotherapy, radiation, and hormone therapy, which broadly target cancer cells, the dendritic cell (DC) vaccine offers a personalized approach. This vaccine is crafted using the patient's own tumor data to create a customized attack plan, targeting specific neoantigens unique to their cancer. Researchers are excited because this tailored strategy has the potential to boost the immune system's ability to recognize and destroy cancer cells more effectively, offering a promising new avenue in cancer treatment.

What evidence suggests that the Dendritic Cell Vaccine might be an effective treatment for breast cancer?

Research has shown that dendritic cell vaccines, which participants in this trial will receive, can help the immune system fight breast cancer. In some studies, 46% of patients maintained stable disease after receiving the vaccine, although no patients were completely cured. The vaccine might also work well with chemotherapy, especially for certain types like HER2-positive tumors. It increases the number of immune cells in tumors, which can be promising for treatment results. Overall, these vaccines have the potential to boost the body's natural defenses against breast cancer. ^{2 3 6 7 8}

Who Is on the Research Team?

Hatem Soliman, MD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with a high-risk type of breast cancer known as TNBC, who have already undergone initial chemotherapy. Participants should be those whose tumors still remain after this treatment and are willing to undergo further procedures to create a personalized vaccine.

Inclusion Criteria

My breast cancer is at stage II-III, mostly not hormone-driven, HER2 negative, and still significant after initial treatment.

Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.

My organs and bone marrow are working well.

Exclusion Criteria

Patients who have a medical issue in the opinion of the treating physician and/or PI that would make them unsuitable for pheresis.

Patients with significant uncontrolled intercurrent illness or autoimmune disease requiring systemic immunosuppressants that would be deemed unsuitable to participate in the study by the Principal Investigator (PI).

My cancer is advanced and cannot be removed by surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a personalized dendritic cell vaccine based on whole exome sequencing data of their residual breast tumor

Up to 3 years

Follow-up

Participants are monitored for safety, immunogenicity, and disease-free survival after treatment

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Dendritic Cell (DC) Vaccine

Trial Overview The study is testing the safety and immune response to a new breast cancer vaccine made from patients' own tumor information. It involves taking white blood cells through leukapheresis (a lab procedure) and using them to create the vaccine.

How Is the Trial Designed?

Group I: Dendritic Cell (DC) Vaccine Experimental Treatment 2 Interventions

The tumor specimen collected from the primary tumor will undergo whole exome sequencing (WES). The WES data will be analyzed to select up to 20 neoantigens. From this screen up to 10 peptides will be selected to be synthesized for testing and use on the DC pheresis product that will be collected. The ready vaccine product will be cryopreserved and then thawed once the patient is ready to under the vaccination sequence.

Dendritic Cell (DC) Vaccine is already approved in United States, European Union for the following indications:

Approved in United States as Dendritic Cell Vaccine for:

• Triple-Negative Breast Cancer (TNBC)
• HER2+ Breast Cancer
• Leptomeningeal Disease

Approved in European Union as Dendritic Cell Vaccine for:

• Breast Cancer
• Advanced Breast Cancer
• Metastatic Breast Cancer

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Published Research Related to This Trial

An autologous dendritic cell (DC) vaccine developed for breast cancer showed promising in vitro efficacy, eliciting a strong cytotoxic T-lymphocyte response against autologous breast cancer cells in 12 female patients with early-stage disease.

The matured DCs demonstrated significant upregulation of activation markers and produced high levels of the cytokine IL12-p70, indicating their potential effectiveness in stimulating the immune response, and they maintained viability and safety after cryopreservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An autologous dendritic cell vaccine polarizes a Th-1 response which is tumoricidal to patient-derived breast cancer cells. Tomasicchio, M., Semple, L., Esmail, A., et al.[2020]

In a Phase I trial involving 32 patients with metastatic breast and renal cancer, a vaccine created by fusing patients' own tumor cells with dendritic cells was found to be safe, with no significant treatment-related toxicity or signs of autoimmunity.

The vaccination led to immunological responses, including increased T cell activity, and resulted in disease regressions in two breast cancer patients and stabilization in several others, indicating potential efficacy in inducing anti-tumor responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fusion cell vaccination of patients with metastatic breast and renal cancer induces immunological and clinical responses. Avigan, D., Vasir, B., Gong, J., et al.[2020]

The study involved breast cancer patients who received dendritic cell vaccines made from their own tumor lysates, showing no serious adverse effects and a strong immune response with increased Th1 cytokine secretion and NK cells.

Patients who received the DC vaccine had a significantly longer 3-year progression-free survival rate (76.9%) compared to those who did not receive the vaccine (31.0%), indicating its potential effectiveness in delaying disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous dendritic cell vaccine for estrogen receptor (ER)/progestin receptor (PR) double-negative breast cancer. Qi, CJ., Ning, YL., Han, YS., et al.[2022]

Dendritic cell (DC) vaccination has been studied in over 1000 patients across 98 trials for various cancer types, showing that it can effectively stimulate T cell antitumor immune responses, particularly in cancers like melanoma and prostate cancer.

The safety profile of DC vaccination is favorable, with most adverse effects being mild and self-limited, suggesting it is a promising and safe approach to cancer immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The first 1000 dendritic cell vaccinees. Ridgway, D.[2021]

Dendritic cell-based immunotherapy for cancer is shown to be feasible and safe, successfully inducing tumor-specific immune responses in some vaccinated patients.

Enhancing the therapy by loading dendritic cells with specific peptides or using mRNA electroporation can boost the activation of both cytotoxic and helper T cells, potentially improving the overall antitumor response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Importance of helper T-cell activation in dendritic cell-based anticancer immunotherapy. Schreibelt, G., Bol, KF., Aarntzen, EH., et al.[2021]

The study involved 10 cancer patients (6 with renal cell carcinoma and 4 with breast cancer) who received a dendritic cell vaccine combined with IL-2, which was well tolerated and showed no major side effects.

While the vaccine induced specific immune responses in six patients, only one patient with renal cell carcinoma showed stable disease, suggesting that a combination of immune activation and reduction of inhibitory immune factors may be necessary for clinical benefit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination therapy of renal cell carcinoma or breast cancer patients with dendritic cell vaccine and IL-2: results from a phase I/II trial. Baek, S., Kim, CS., Kim, SB., et al.[2021]

Dendritic cell (DC) vaccines have shown considerable anti-tumor effects in breast cancer treatment, with some already in clinical trials, highlighting their potential as a promising immunotherapy option.

This review discusses the immunomodulatory effects and mechanisms of DC vaccines, suggesting that while they offer new avenues for treatment, there are still challenges to overcome in their development and application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dendritic cell vaccines in breast cancer: Immune modulation and immunotherapy. Qian, D., Li, J., Huang, M., et al.[2023]

Dendritic cell-based vaccination has shown promise as a specific immunotherapy for cancer, with over 1,000 patients participating in trials demonstrating the ability to activate the immune system against cancer cells.

While some patients experienced clinical responses, the treatment remains experimental, highlighting the need for further well-designed trials to enhance the effectiveness of dendritic cell vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dendrite cell-based cancer vaccines--clinical application]. Svane, IM., Berntsen, A., Trepiakas, R., et al.[2006]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10315441/

Efficacy of a Dual-Epitope Dendritic Cell Vaccine as Part of ... Forty-six percent of patients had stable disease after therapy, with 4% achieving a partial response and no complete responses. Immune responses were generated ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0753332223004730

Dendritic cell vaccines in breast cancer In this review, we summarize the immunomodulatory effects and related mechanisms of DC vaccine in breast cancer as well as the progress of clinical trials.

3. moffitt.org moffitt.org/newsroom/news-releases/moffitt-study-finds-vaccine-may-improve-breast-cancer-treatment-outcomes/

Moffitt Study Finds Vaccine May Improve Breast Cancer ... Dendritic cell vaccine shows potential to enhance chemotherapy effectiveness in HER2-postitive, ER-negative subtype.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04348747

NCT04348747 | Dendritic Cell Vaccines Against Her2/Her3 ... This phase IIa trial studies how well dendritic cell vaccines against Her2/Her3 and pembrolizumab work for the treatment of triple negative breast cancer or ...

5. nature.com nature.com/articles/s41523-025-00742-x

A pilot study incorporating HER2-directed dendritic cells ... The HER2 DC1 vaccine caused a significant influx of T cell infiltrates into treated tumors, and this could potentially be greater in patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3789057/

Immune response, clinical outcome and safety of dendritic ... The therapy was safe and no serious adverse side-effects similar to those caused by chemotherapy and radiotherapy were observed. The regimen may have a ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02018458

Safety Study Of Chemotherapy Combined With Dendritic ... The primary objective of this study is to determine the safety and feasibility of combining cyclin B1/WT-1/CEF (antigen)-loaded DC vaccination with ...

8. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-03214

A Vaccine (Dendritic Cell 1) for the Treatment of Patients ... This phase II trial studies the side effects and best dose of dendritic cell (DC1) vaccine in treating patients with HER-2 positive breast cancer.