A Personalized Neoantigen Cancer Vaccine in Treatment Naïve, Asymptomatic Patients With IGHV Unmutated CLL.

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03219450
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NeoVax — DRUG
    It stimulates the immune system to attack cancer cells.
  • Cyclophosphamide — DRUG
    It 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 — DRUG
    Is a monoclonal antibody that helps the immune cells to be better at attacking cancer cells.

Study Details

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

Key Dates

Start date
Aug 18, 2021
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: NeoVax
    * NeoVax will be administered in a priming and booster phase. * The priming shots will comprise days 1, 4, 8, 15, and 22. * Booster shots will be given on days 78 and 134.
  • Experimental: Neovax + Low-dose cyclophosphamide
    * NeoVax will be administered in a priming and booster phase. * The priming shots will comprise days 1, 4, 8, 15, and 22. * Booster shots will be given on days 78 and 134. * Low dose cyclophosphamide is administered twice daily on weeks -2, 1, 3, 5
  • Experimental: Neovax + Low-dose cyclophosphamide + Pembrolizumab
    * NeoVax will be administered in a priming and booster phase. * The priming shots will comprise days 1, 4, 8, 15, and 22. * Booster shots will be given on days 78 and 134. * Low dose cyclophosphamide is administered twice daily on weeks -2, 1, 3, 5 * Pembrolizumab will be administered starting on Week 12 Day 78 and for up to 17 cycles (approximately 1 year).

Primary Outcome Measure

Feasibility of neoantigen identification [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Inhye E Ahn, MD
Inhye Ahn, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Dana-Farber Cancer Institute· Boston, MA

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