Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00058591
Other study ID # H8216
Secondary ID SCAEBV
Status Completed
Phase Phase 1
First received
Last updated
Start date January 2000
Est. completion date December 2008

Study information

Verified date January 2020
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Severe chronic active Epstein-Barr virus (SCAEBV) is a rare Epstein-Barr virus (EBV or commonly known as mono or the kissing disease) associated disorder. This disorder may cause chronic tiredness and fevers and sometimes be complicated by life threatening problems such as multi-organ failure, chronic (ongoing) pneumonia, and lymphoproliferative diseases (diseases involving the lymph nodes which could eventually show up as leukemia or a tumor). The reasons for the body's inability to control the EBV infection are still unknown and no effective treatment is currently available.

This research study uses Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTLs). We want to see if we can grow special white blood cells, called T cells, that have been trained to kill EBV infected cells in the laboratory and see if these cells may help control the EBV infection when given back to the patient.

The purpose of this study is to find the largest safe dose of EBV specific CTLs, to learn what the side effects are, and to see whether this therapy might help the body fight off the SCAEBV infection.


Description:

Ten to sixty ml (2-12 teaspoons) of blood will be collected from the patient which we use to grow the T cells. These T cells are then stimulated with EBV infected cells (which have been treated with radiation so that they cannot grow). This stimulation trains the T cells to kill EBV infected cells. We then test the T cells to make sure that they kill the EBV infected cells.

Therapy can take place in one of the specifically designated outpatient clinics so hospital admission is not required. First, patients will be given doses of Tylenol (for any aches/pains) and Benadryl (for any minor allergic reactions such as itching/rash). Next, the T cells will be injected into a vein over a 10 minute period. Patients will be closely watched for any side effects.

If a patient shows some response to the treatment they may receive up to three additional T cell injections at three month intervals. Patients will need to be seen every other week in the clinic for six weeks after the injection. Following that, patients will either be seen in the clinic or contacted by one of the research staff working on this study, once a month for one year.

To learn more about the way the T cells are working and how long they last in the body, an extra 40 mls(8 teaspoonfuls) of blood will be taken at these visits. Additionally, 3 mls (1/2 teaspoonful) of blood will be taken prior to the infusion and monthly thereafter to conduct a CBC (a test to look at the components of the blood).


Other known NCT identifiers
  • NCT00608608

Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients must have severe chronic EBV infection as manifested by 6 months of symptoms Either elevated peripheral blood EBV DNA (>4000 genomes per ug PBMC DNA) or free EBV DNA in serum or CSF or VCA antibody titer > 1/640

- Seronegative for HIV

- Not on investigational agents in the last 4 weeks

- Signed informed consent obtained from patient/guardian

- CTLs available

- Performance status; Karnofsky >60

- Creatinine < 3X normal

- Bilirubin < 5X normal

- Normal electrolytes, calcium, phosphorus, nutritional status

- Females with child-bearing potential must utilize effective birth control.

Exclusion Criteria:

- Patients with a severe intercurrent infection

- Patients that recently received high dose steroids within the last week or other immunosuppressive drugs within a week (or longer as indicated by the half life of the agent)

- Patients with life expectancy of less than 6 weeks

- Pregnant or lactating females

Study Design


Intervention

Biological:
Intravenous injection of EBV specific CTLS
The dose levels for this study are as follows: Level Dose 2 x 107 CTLs/m2 5 x 107 CTLs/m2 1 x 108 CTLs/m2 If patients have a clinical response to the first infusion defined by an improvement in the fatigue score or resolution of clinical abnormalities such as lymphadenopathy or an improvement in laboratory parameters such as a decrease in VCA titer or reduction in free EBV DNA they will be eligible to receive up to 3 additional injections of CTLs at the original dose at 3 monthly intervals.

Locations

Country Name City State
United States Texas Children's Hospital Houston Texas
United States The Methodist Hospital Houston Texas

Sponsors (3)

Lead Sponsor Collaborator
Baylor College of Medicine Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary to determine the safety of intravenous injections of autologous EBV specific cytotoxic T cell lines in individuals with severe chronic EBV infection 1 yr
Secondary determine antiviral and immunological efficacy of intravenous injections of CTLs in these patients 1 yr
Secondary assess the clinical effects of these injections 1 yr
See also
  Status Clinical Trial Phase
Completed NCT01256853 - Modified Vaccinia Ankara (MVA) Vaccine Study Phase 1
Completed NCT00070785 - Protein Studies of the Epstein-Barr Virus in Ethnically Diverse Populations N/A
Recruiting NCT01248598 - The Prevelance Rate of Human Cytomegalovirus (HCMV), Epstein-Barr Virus (EBV) and Human Herpes Virus (HHV-6) in a Saliva of the Patient With Periodantitis N/A
Completed NCT00701922 - Surveillance Study of Viral Infections Following Lung Transplantation N/A
Recruiting NCT02580539 - A Study of the Safety and Efficacy of EBV Specific T-cell Lines Phase 1/Phase 2
Completed NCT03546101 - Early Detection of Epstein-Barr Virus Related Disease.
Recruiting NCT05183490 - R-MVST Cells for Treatment of Viral Infections Phase 1
Completed NCT00058812 - Giving Epstein-Barr Virus (EBV) Specific Killer T Lymphocytes to Patients Who Have Had Donor Marrow Grafts Phase 1
Completed NCT01094405 - Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy Phase 2
Terminated NCT05305040 - Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant Phase 2/Phase 3
Completed NCT02335437 - Chronic Fatigue Following Acute Epstein-Barr Virus Infection in Adolescents N/A
Completed NCT06002802 - Study on Infectious Mononucleosis in Munich
Recruiting NCT03266653 - EBV-specific Cytotoxic T-lymphocytes (CTLs) for Refractory EBV Infection Phase 2
Recruiting NCT04507477 - Ex-vivo Delivery of Rituximab to Prevent PTLD in EBV Mismatch Lung Transplant Recipients: A Pilot Trial Phase 1/Phase 2
Completed NCT00963248 - EBV Infection as a Risk Factor for PTLD in Pediatric and Adult Renal Transplant Recipients N/A
Enrolling by invitation NCT06027879 - Anti-viral T-cell Therapy by Gamma Capture Phase 1/Phase 2
Recruiting NCT05592626 - A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors Phase 1/Phase 2
Completed NCT02715752 - A Retrospective Chart Review Study of Gene-Eden-VIR/Novirin N/A
Completed NCT01070797 - Administration of Rapidly Generated Multivirus-specific Cytotoxic T-Lymphocytes (VIRAGE) Phase 1
Completed NCT00058604 - Prevention and Treatment of Epstein-Barr Virus (EBV) Lymphoma Following a Solid Organ Transplant Using EBV Specific Cytotoxic T Lymphocytes (CTLs). Phase 1