This research study is studying a novel type of CLL vaccine as a possible treatment for chronic lymphocytic leukemia (CLL)
The names of the study interventions involved in this study are:
* Personalized NeoAntigen Vaccine * Poly-ICLC * Cyclophosphamide * Pembrolizumab
Diagnosis of CLL as per IWCLL 2018 criteria
Patient's CLL must have an unmutated immunoglobulin heavy chain variable (IGHV) region gene, defined as < 2% mutated compared to germline.
Patient must have had no history of CLL-directed therapy due to meeting IWCLL 2018 criteria; no present indication for treatment by iwCLL 2018 criteria; and in the opinion of the treating investigator be anticipated not to require CLL-directed treatment within the next 6 months.
Patient must have measurable disease (absolute lymphocyte count > 10K/uL or total white blood cell count ≥ 20K/uL of peripheral blood).
Prior therapy for CLL that met IW-CLL treatment criteria, including chemotherapy, targeted therapies (e.g. that antagonize B cell receptor signaling), or immunotherapy (including but not limited to monoclonal antibodies); or radiotherapy or hormonal therapy within the last 2 years of screening registration.
Participants who are receiving any other investigational agents.
Previous bone marrow or stem cell transplant
Concomitant therapy with immunosuppressive or immunomodulatory agents; chronic use of systemic corticosteroids. Previous history of corticosteroid use is acceptable. Use of corticosteroids after initial registration is acceptable if tapered at least one week before NeoVax administration.
Sequential
NeoVax
DrugIt stimulates the immune system to attack cancer cells.
Cyclophosphamide
DrugIt is a chemotherapy drug used to treat many cancers. At low doses, it is an investigational drug to help the immune cells to be better at attacking cancer cells while avoiding chemotherapy toxicity.
Pembrolizumab
DrugIs a monoclonal antibody that helps the immune cells to be better at attacking cancer cells.
Feasibility of neoantigen identification
The proportion of all enrolled patients for whom sequencing and analysis leads to identification of at least 7 actionable peptides to initiate vaccine production
Feasibility of vaccine generation
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
Safety of NeoVax
The number of patients with treatment-limiting toxicities based on NCI CTCAE v5.0
Click on the lead sponsor to view all of their trials.
Dana-Farber Cancer Institute
Lead sponsor
Oncovir, Inc.
Collaborator
BioNTech SE
Collaborator
Merck Sharp & Dohme LLC
Collaborator
