Nivolumab With Epstein Barr Virus Specific T Cells (EBVSTS), Relapsed/Refractory EBV Positive Lymphoma (PREVALE)

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT02973113
Phase
PHASE1
Status
Completed

Conditions

  • EBV Related Hodgkin's Lymphoma
  • EBV Related Lymphoma
  • EBV Related Non-Hodgkin's Lymphoma
  • EBV-Related PTLD
  • Hodgkin Lymphoma
  • Lymphoproliferative Disorders
  • NonHodgkin Lymphoma

Eligibility Criteria

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

Interventions

  • EBVST Cells — BIOLOGICAL
    EBVST cells in an expected volume of 10-20cc will be given by intravenous injection over 2-10 minutes through either a peripheral or a central line.
  • Nivolumab — BIOLOGICAL
    Nivolumab 3mg/kg (max dose: 240 mg) will be administered as an intravenous infusion over 60 minutes.

Study Details

Subjects have a type of a lymph node cancer called Non-Hodgkin's Lymphoma (NHL) or lymphoproliferative disease (LPD), which affects their immunity, blood production, and can involve multiple other organs in the body. Their disease has come back or has not gone away after treatment. The experimental treatment plan consists of an antibody therapy called "Nivolumab" that helps the subjects' T-cells control the tumor, and special immune system cells called EBV-specific cytotoxic T lymphocytes, also a new therapy whose side effects are well studied. Some patients with NHL or LPD are infected with the virus that causes infectious mononucleosis (called Epstein-Barr virus, or EBV) before or at the time of their diagnosis. The cancer cells that are infected by EBV are able to hide from the body's immune system and escape destruction. Investigators want to see if special white blood cells, called T cells, that have been trained to kill cells infected by EBV can survive in the blood and affect the tumor. Investigators have used this sort of therapy to treat a different type of cancer that occurs after bone marrow or solid organ transplant called post-transplant lymphoma with good success. These cells are called EBV-specific cytotoxic T-lymphocytes (EBVSTs), and are effective in treating these diseases. These EBVSTs are experimental and not yet approved by the Food and Drug Administration (FDA). Sometimes it is not possible to grow these cells; or they may not last very long in the body after being given into the vein thereby having only limited time to fight the tumor. With this study, investigators aim to increase the duration of time that the T cells can last in the body and can effectively fight the cancer by using nivolumab. Nivolumab is FDA approved for treatment of other kinds of cancer like lung cancer and a skin cancer called Melanoma. The purpose of this study is to find out if EBVST cells in combination with nivolumab are safe, to learn what the side effects are, and to see whether this therapy may help patients with EBV related lymphoma or LPD.

Key Dates

Start date
Feb 16, 2016
Status verified
Jul 2021
Primary completion
Sep 5, 2019
Completion
Jul 11, 2020

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: EBVST Cells + Nivolumab
    PD1 inhibitor - nivolumab 3 mg/kg (max dose: 240 mg) Q 2 weeks for total 4 doses and repeat a day prior to each EBVST infusion. EBVST- 1 x 10\^8/m2 at days +1 and +15. PD1 inhibitor - nivolumab 3 mg/kg (max dose: 240 mg) Q 2 weeks for total 4 doses and repeat a day prior to each EBVST infusion. Can receive up to 3 additional infusions of EBVSTs with a single dose of nivolumab at 6-12 week intervals starting at least 6 weeks after the second infusion if stable disease or a partial response at Week 8 evaluation

Primary Outcome Measure

Number of Dose-Limiting Toxicities [ Time Frame: 2 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Houston Methodist HospitalHoustonTexas77030-
Texas Children's HospitalHoustonTexas77030-

Find similar trials in Houston, TX

By research site
Houston Methodist Hospital· Houston, TXTexas Children's Hospital· Houston, TX

Related Studies