Dendritic Cell Immunotherapy for Triple Negative Breast Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Roswell Park Cancer Institute

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Autoimmune disease, CNS metastases, 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: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a combination treatment using dendritic cell therapy (Alpha-type-1 Polarized Dendritic Cells) and pembrolizumab can safely and effectively treat triple-negative breast cancer that has spread or cannot be surgically removed. Dendritic cell therapy helps the immune system recognize and attack cancer cells, while pembrolizumab boosts the body's natural defenses against cancer. The trial targets individuals with triple-negative breast cancer who have no other curative options and have specific tumors suitable for biopsy. Participants should not currently use strong immune-suppressing drugs or have certain heart conditions. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to significant advancements in cancer therapy.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressive agents, including steroids, you must stop them at least 3 weeks before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that treatments using dendritic cells can moderately improve the quality of life for some cancer patients by helping the immune system fight cancer cells. Although limited safety information exists specifically for patients with triple-negative breast cancer, these therapies are generally considered safe.

For pembrolizumab, studies have indicated it is generally safe for patients with triple-negative breast cancer. However, some patients have experienced immune-related side effects, which can be serious and affect different parts of the body. In very rare cases, these side effects can be life-threatening, occurring in about 0.3% of patients.

Overall, both treatments have been used in other cancer studies and are generally well-tolerated, but risks remain. Participants should discuss these potential risks with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for triple-negative breast cancer, which often involves chemotherapy, the investigational treatment combines alpha-type-1 polarized dendritic cells with pembrolizumab, a monoclonal antibody. This treatment is unique because it harnesses the body's immune system in a novel way. The dendritic cells help boost the immune response by presenting cancer antigens more effectively, while pembrolizumab, an immune checkpoint inhibitor, unleashes the immune system to attack cancer cells. Researchers are excited because this dual approach could offer a more targeted and potentially less toxic alternative to traditional chemotherapy, with the hope of better outcomes for patients.

What evidence suggests that dendritic cell immunotherapy and pembrolizumab might be effective for triple negative breast cancer?

Research has shown that alpha-type-1 polarized dendritic cells (aDC1s), a type of immune cell, can help the body’s immune system identify and destroy triple-negative breast cancer (TNBC) cells. In this trial, participants will receive a combination of aDC1s and Pembrolizumab. Studies combining these immune cells with other treatments have yielded promising results in TNBC patients. Pembrolizumab, a drug that aids the immune system in fighting cancer, has also proven effective in treating TNBC. In clinical trials, it improved survival rates and slowed cancer progression when used with chemotherapy. Both treatments enhance the body's natural defense against cancer. ^{1 2 5 6 7}

Who Is on the Research Team?

Shipra Gandhi

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults with triple negative breast cancer that has spread or can't be surgically removed. Participants need at least two target lesions, normal liver and blood function, and must use birth control if of child-bearing potential. Exclusions include active infections, certain heart conditions, immunodeficiency disorders, recent vaccine administration, and brain metastases.

Inclusion Criteria

I have at least 2 tumors that can be measured and one can be biopsied.

Your AST and ALT levels in your blood are not too high. If you have liver metastases, your ALT levels should not be more than five times the normal limit.

Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. 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

Exclusion Criteria

I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

I had radiotherapy over 2 weeks ago, recovered from side effects, and didn't have lung inflammation from it.

I haven't taken strong immune system suppressants or high-dose steroids in the last 3 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Leukapheresis

Patients undergo leukapheresis over 90 minutes to collect cells for dendritic cell preparation

1 day

1 visit (in-person)

Treatment

Patients receive ST-alpha-DC1 intratumorally on days 1, 8, and 50 and pembrolizumab intravenously on days 8, 29, 50, and 71

12 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Follow-up visits every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Alpha-type-1 Polarized Dendritic Cells
• Pembrolizumab

Trial Overview The trial tests a combination of dendritic cell-based treatment to boost the immune system's ability to fight cancer cells and pembrolizumab—an immune checkpoint inhibitor—to potentially enhance this effect. The goal is to see if these treatments together can reduce symptoms and improve life quality in patients.

How Is the Trial Designed?

Group I: Treatment (ST-alpha-DC1, pembrolizumab) Experimental Treatment 6 Interventions

Patients undergo leukapheresis over 90 minutes. Patients then receive ST-alpha-DC1 IT on days 1, 8, and 50 in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV on days 8, 29, 50, and 71 in the absence of disease progression or unacceptable toxicity. Patients who are receiving clinical benefit from treatment at the end of day 85, may continue to receive pembrolizumab IV every 3 weeks beyond the 4 study doses. Patients also undergo tumor biopsies on days 1, 8, and 50 and CT scans at baseline and days 50 and 85.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0305737225000064

Dendritic cells in triple-negative breast cancer This review aims to provide a comprehensive overview of TNBC, including potential targets and pharmacological strategies, as well as an overview of DCs and ...

2. cancertreatmentreviews.com cancertreatmentreviews.com/article/S0305-7372(25)00006-4/pdf

Dendritic cells in triple-negative breast cancer For this reason, studies have combined DCs vaccines and chemotherapy and achieved good results, including in TNBC [19]. Targeted therapies.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11365501/

Recent Advances in Immunotherapy for Breast Cancer Runx2-dendritic cell gene vaccine induces specific cellular immunity to kill triple negative breast cancer. J Sun Yat-sen Unive. 2015;36(3):377– ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04093323

Study Details | NCT04093323 | Polarized Dendritic Cell ... This phase II trial studies how well polarized dendritic cell (aDC1) based therapy, interferon alpha-2, rintatolimod, and celecoxib work together in treating ...

5. delta.larvol.com delta.larvol.com/Products/?ProductId=ffb9e36f-dc18-48b8-8993-64edfde657f3

aDC1 vaccine / Roswell Park, University of Pittsburgh - "Alpha-type-1-polarized dendritic cells (aDC1s) have been shown to induce ... triple negative breast cancer or HER2+ breast cancer. (ASCO 2023) - P2a ...

6. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/1471-2407-12-623

α-type-1 polarized dendritic cell-based vaccination in ... DC-based vaccines against high-grade gliomas have moderate effects in terms of a patient`s performance status (PS) or quality of life (QOL) [14] ...

7. cancer.gov cancer.gov/publications/dictionaries/cancer-drug/def/alpha-type-1-polarized-dendritic-cells

Definition of alpha-type-1 polarized dendritic cells When pulsed with specific tumor associated antigens (TAAs), alphaDC1 is able to induce a potent cytotoxic T-lymphocyte (CTL) response against TAAs; as a result ...