Neoantigen Vaccine for Advanced Cancer

Recruiting at 4 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Jaime Leandro Foundation for Therapeutic Cancer Vaccines

Must be taking: Folfirinox

Must not be taking: Immunosuppressive therapies

Disqualifiers: Immunodeficiency, Autoimmune, Psychiatric, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

136 Participants Needed

Trial Summary

What is the purpose of this trial?

A Phase 1b/2, Multi-center, Single Arm Study to Assess the Safety and Efficacy of Neoantigen Synthetic Long Peptide Vaccines in Patients With Local Or Metastatic Solid Tumors

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on medications that interfere with the vaccine or are immunosuppressive, you may need to adjust them. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Personalized Synthetic Long Peptide Vaccine, Neoantigen Vaccine for advanced cancer?

Research shows that neoantigen vaccines can trigger strong immune responses by targeting unique mutations in cancer cells, leading to tumor control. In a study, patients with melanoma who received a neoantigen vaccine showed enhanced T cell responses, and some experienced no cancer recurrence or complete tumor regression when combined with other therapies. ^{1 2 3 4 5}

Is the neoantigen vaccine safe for humans?

Research shows that the neoantigen vaccine is generally safe in humans, with no serious side effects reported in clinical trials for advanced cancers like melanoma, lung, and bladder cancer. ^{1 2 6 7 8}

How is the Neoantigen Vaccine treatment different from other cancer treatments?

The Neoantigen Vaccine is unique because it is personalized for each patient, targeting specific mutations in their tumor cells to stimulate a strong immune response. Unlike traditional treatments, it uses synthetic long peptides to induce both CD4+ and CD8+ T cell responses, enhancing tumor-specific immunity and reducing the risk of harming normal tissues. ^{1 2 7 8 9}

Eligibility Criteria

Adults with advanced solid tumors that have worsened after standard treatments, or when no effective standard treatment exists, or if they can't receive standard therapy. They should be in a condition where their survival chance is below 50% over the next five years and must not have severe allergies to vaccines or ingredients in the study vaccine.

Inclusion Criteria

Ability to understand and willingness to sign an IRB approved written informed consent document

My advanced cancer has low survival odds and has not responded to standard treatments.

My doctor believes my organs are functioning well enough for treatment.

Exclusion Criteria

History of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty or known allergy to a component of the neoantigen synthetic long peptide vaccine

I will use birth control or abstain from sex during and for 3 months after the study.

Psychiatric illness or social situations that would limit compliance with study requirements

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Neoantigen Synthetic Long Peptide Vaccines

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

• Personalized Synthetic Long Peptide Vaccine

Trial Overview The trial is testing personalized synthetic long peptide vaccines designed for each patient's unique tumor makeup. Up to 20 participants will receive these custom-made vaccines aimed at treating various advanced cancers.

Participant Groups

Group I: Personalized Synthetic Long Peptide Vaccine Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Jaime Leandro Foundation for Therapeutic Cancer Vaccines

Lead Sponsor

Trials

1

Recruited

20+

Findings from Research

Neoantigen vaccines, particularly those using long synthetic peptides derived from tumor mutations, show promise in improving tumor-specificity and reducing side effects compared to traditional cancer vaccines.

These long peptides can potentially enhance immune responses by overcoming immune tolerance, leading to activation of both CD4+ and CD8+ T cells, which are crucial for effective cancer immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized neoantigen vaccination with synthetic long peptides: recent advances and future perspectives. Chen, X., Yang, J., Wang, L., et al.[2021]

A phase 1B study demonstrated that a personalized neoantigen vaccine combined with PD-1 blockade can stimulate strong T cell responses in patients with advanced cancers.

This combination therapy shows potential for enhancing tumor destruction and improving clinical outcomes, suggesting a promising approach for cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Personalized Neoantigens Raise the T Cell Bar? Zaidi, N.[2022]

A personalized neoantigen nanovaccine combined with anti-PD-1 antibody treatment led to a significant clinical benefit in an advanced pancreatic cancer patient, resulting in an overall survival of 10.5 months after treatment.

The treatment successfully induced a robust T cell response against multiple vaccine peptides, indicating that this approach may effectively enhance immune responses in controlling progressive metastatic pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced Pancreatic Cancer Patient Benefit From Personalized Neoantigen Nanovaccine Based Immunotherapy: A Case Report. Shao, J., Liu, Q., Shen, J., et al.[2023]

The personalized neoantigen-based vaccine NEO-PV-01, combined with PD-1 blockade, was found to be safe in a phase Ib trial involving 82 patients with advanced melanoma, lung, or bladder cancer, with no serious treatment-related adverse events reported.

The vaccine successfully induced strong CD4+ and CD8+ T cell responses, which not only targeted the specific neoantigens but also led to an immune response against additional neoantigens, indicating a broadening of the immune attack on the tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase Ib Trial of Personalized Neoantigen Therapy Plus Anti-PD-1 in Patients with Advanced Melanoma, Non-small Cell Lung Cancer, or Bladder Cancer. Ott, PA., Hu-Lieskovan, S., Chmielowski, B., et al.[2023]

Personalized neoantigen vaccines are a promising new approach in cancer immunotherapy, designed to stimulate T cell responses specifically against tumor-specific neoantigens unique to individual patients.

Initial clinical studies have shown that these vaccines can generate strong immune responses and exhibit preliminary antitumor activity, particularly in melanoma and other cancers, thanks to advancements in sequencing and bioinformatics technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the development of personalized neoantigen-based therapeutic cancer vaccines. Blass, E., Ott, PA.[2023]

References

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

An immunogenic personal neoantigen vaccine for patients with melanoma. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Personalized neoantigen vaccination with synthetic long peptides: recent advances and future perspectives. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Identification and Targeting of Mutant Peptide Neoantigens in Cancer Immunotherapy. [2021]

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

Can Personalized Neoantigens Raise the T Cell Bar? [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Advanced Pancreatic Cancer Patient Benefit From Personalized Neoantigen Nanovaccine Based Immunotherapy: A Case Report. [2023]

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

A Phase Ib Trial of Personalized Neoantigen Therapy Plus Anti-PD-1 in Patients with Advanced Melanoma, Non-small Cell Lung Cancer, or Bladder Cancer. [2023]

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

Getting personal with neoantigen-based therapeutic cancer vaccines. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Case Report: Targeting of individual somatic tumor mutations by multipeptide vaccination tailored for HLA class I and II presentation induces strong CD4 and CD8 T-cell responses in a patient with metastatic castration sensitive prostate cancer. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Advances in the development of personalized neoantigen-based therapeutic cancer vaccines. [2023]