A Personalized Neoantigen Cancer Vaccine in Treatment Naïve, Asymptomatic Patients With IGHV Unmutated CLL.
NCT03219450 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2025-05-22
Summary
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
Conditions
- Lymphocytic Leukemia
Interventions
- DRUG
-
NeoVax
It stimulates the immune system to attack cancer cells.
- 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.
- DRUG
-
Is a monoclonal antibody that helps the immune cells to be better at attacking cancer cells.
Sponsors & Collaborators
-
Oncovir, Inc.
collaborator INDUSTRY - collaborator INDUSTRY
- collaborator INDUSTRY
- lead OTHER
Principal Investigators
-
Inhye Ahn, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-08-18
- Primary Completion
- 2027-05-31
- Completion
- 2028-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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