A Pilot Study of a Personalized Neoantigen Cancer Vaccine Following Front-Line Rituximab in Follicular Lymphoma
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|ClinicalTrials.gov Identifier: NCT03361852|
Recruitment Status : Not yet recruiting
First Posted : December 5, 2017
Last Update Posted : June 24, 2019
This research study is studying a novel type of FL vaccine as a possible treatment for follicular lymphoma (FL).
The agents involved in this study are:
- Personalized NeoAntigen vaccine
|Condition or disease||Intervention/treatment||Phase|
|Follicular Lymphoma||Drug: Rituximab Biological: Neo Vax||Phase 1|
This research study is a Pilot Study, which is the first time investigators are examining the Personalized Neoantigen Vaccine (NeoVax) in patients diagnosed with follicular lymphoma. The FDA (the U.S. Food and Drug Administration) has not approved the Personalized Neoantigen Vaccine as a treatment for any disease.
The purpose of this study is to determine if it is possible to make and safely administer a vaccine against FL by using information gained from specific genetic characteristics of the participant own FL. The investigators plan to analyze the specific genetic characteristics of the participant own FL (mutations) and use that information to produce proteins that may help the participant's immune system recognize and fight FL cells.
This vaccine is also being tested in clinical trials in patients with advanced melanoma (a type of skin cancer) or glioblastoma (a type of brain cancer). The current study will examine the ability of the vaccine to stimulate the participant's immune system when given at several different timepoints, and will examine the participant's blood cells for signs that the FL has changed or decreased.
FL cells will be obtained from lymph node biopsy, blood draws or effusion. The genetic material contained in the FL cells will be examined for the presence of tumor-specific mutations. This information will be used to prepare small protein fragments, which are called "peptides." The vaccine will consist of up to 20 of these peptides as well as a drug called Poly-ICLC. A peptide from the tetanus vaccine will also be included to boost the immune response.
Poly-ICLC (also called Hiltonol) is an experimental "viral mimic" and an activator of immunity. Poly-ICLC binds proteins on the surface of certain immune cells to make it appear as if a virus is present. When the cells detect the vaccine, they think it is a virus and turn on the immune system. Poly-ICLC will be mixed with NeoAntigen peptides and administered as an injection given underneath the skin. Poly-ICLC is an investigational drug, meaning the FDA has not approved it as a treatment for any disease.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of a Personalized Neoantigen Cancer Vaccine Following Front-Line Rituximab in Follicular Lymphoma|
|Estimated Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2024|
Experimental: Neo Vax
Rituximab is classified as a monoclonal antibody. It works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells
Other Name: Rituxan
Biological: Neo Vax
Neo Vax is an experimental "viral mimic" and an activator of immunity.
- Feasibility of Neovax following 4 weekly doses of rituximab assessed by the following [ Time Frame: 2 years ]The proportion of all enrolled patients for whom sequencing and analysis leads to identification of at least 7 actionable peptides to initiate vaccine production and, of the patients who generate at least 7 actionable peptides, the proportion for whom the time from sample collection to vaccine availability is less than 12 weeks.
- The proportion of participants who achieve an IFN-γ T cell response to one or more of the peptide pools [ Time Frame: 2 years ]The induction of IFN-γ T-cell response will be based on ELISPOT assessments taken prior to vaccine administration and at week 16 from both peripheral blood draws and bone marrow biopsies. The proportion of patients who achieve more than 55 SFU/106 PBMC or 3 times their baseline level will be presented with a 90% exact binomial confidence interval. Based on a cohort of size 10, the confidence interval will be no wider than 0.55. It is possible that the maximal response will occur at a different sampling time point or will vary between participants. Thus, this time point may vary from week 16.
- The proportion of participants who convert from PR to CR [ Time Frame: 2 years ]The investigators will report the proportion of patients converting from SD to CR/PR or from PR to CR based upon Lugano criteria in a descriptive fashion.
- The proportion of participants who convert from SD to PR/CR [ Time Frame: 2 years ]The investigators will report the proportion of patients converting from SD to CR/PR or from SD to PR or CR based upon Lugano criteria in a descriptive fashion.
- Best Objective Response [ Time Frame: 2 years ]The investigators will report the best objective response (CR, PR, SD, or PD) based upon Lugano criteria in a descriptive fashion.
- To describe the safety and tolerability of NeoVax following 4 weekly doses of rituximab in patient with previously untreated follicular lymphoma [ Time Frame: 2 years ]The investigators will report toxicity in a descriptive fashion using CTCAE version 4.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361852
|Contact: Oriol Olive Noguer, MD||617-632-2581||Oriol_OliveNoguer@dfci.harvard.edu|
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Contact: Oriol Olive Noguer 617-632-2581 Oriol_OliveNoguer@dfci.harvard.edu|
|Principal Investigator: Eric Jacobsen, MD|
|Principal Investigator:||Eric Jacobsen, MD||Dana-Farber Cancer Institute|