Suspended

ACDALAdministration of LMP2a-Specific Cytotoxic T-Lymphocytes Following CD45 Antibody to Patients With Relapsed EBV-Positive Hodgkin's or Non-Hodgkin's Lymphoma

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What is being tested

CD45 antibodies

+ EBV specific T cells

Biological
Who is being recruted

Immune System Diseases+4

+ Immunoproliferative Disorders

+ Lymphatic Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: October 2003
See protocol details

Summary

Principal SponsorBaylor College of Medicine
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2003

Actual date on which the first participant was enrolled.

Investigators first tested a biopsy of the tumor that has already been done to see if the tumor cells are EBV positive. They then got permission to take up to 60ml (12 teaspoonfuls) of blood from the patient or their donor on one or two occasions and used this blood to grow T cells in the laboratory. They first grew a special type of cell called dendritic cells stimulate the T cells and put a specially produced human virus (adenovirus) that carries the LMP-2a gene into the dendritic cells. These dendritic cells were then treated with radiation so they could not grow. They were then used to stimulate T cells. This stimulation trained the T cells to kill cells with LMP-2a on their surface. Investigators then grew these LMP-2a specific CTLs by more stimulation with EBV infected cells (which were made from the patient's blood or their donor's blood by infecting them with EBV in the laboratory). The investigators also put the adenovirus that carries the LMP2 gene into these EBV infected cells to increase the amount of LMP2 that these cells have. Again, these EBV infected cells were treated with radiation so they could not grow. Once sufficient numbers of T cells were made, investigators tested them to make sure they kill cells with LMP2a on their surface. These cells are now ready to give to the patient if they agree to being on this study. Investigators also took up to 500 ml (2 1/2 cups) of extra blood from the patient or their donor, which were frozen. In case the patient's own cells do not recover as expected after the antibody and cell infusions, these cells can be thawed and given back to the patient. If the patient agrees to this treatment they will get treated with the CD45 antibodies for 4 days in a row and then 2-3 days later get a dose of LMP2 specific CTLs. The CD45 antibodies will be given to the patient through a vein for 6-8 hours and monitored for at least 6 hours after the infusion. After the infusion The patient will be checked for the levels of CD45 in the blood at 24 hours (optional) and/or at 48-72 hours after the last infusion to check the level is low enough to give the patient the CTLs. The CTLs will be thawed and injected through a central line, if the patient has one, or through a vein in their arm over 10 minutes, after pretreatment with Tylenol and Benadryl. We will then monitor them in clinic for 4 hours after the injection. All of the treatments will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital or the Methodist Hospital. We will follow the patient in the clinic after the CTL injection. If there is a reduction in the size of the lymphoma on CT or MRI scans as assessed by a radiologist, they can receive up to six additional doses of the T cells if they wish.

Official TitleAdministration of LMP2a-Specific Cytotoxic T-Lymphocytes Following CD45 Antibody to Patients With Relapsed EBV-Positive Hodgkin's or Non-Hodgkin's Lymphoma 
NCT00082225
Principal SponsorBaylor College of Medicine
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

4 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Immune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic Type

Criteria

Inclusion Criteria: * Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non-Hodgkin lymphoma, regardless of the histological subtype or EBV-associated T/NK cell Lymphoproliferative disease. This includes patients in second or subsequent relapse including post autologous or syngeneic stem cell transplant (or with active disease or in first relapse if immunosuppressive chemotherapy contraindicated or if the patient has relapsed multiple times and is currently in remission but has a high risk of relapse). (group A) OR Patients who have relapsed after allogeneic stem cell transplant for Hodgkin's Lymphoma or non-Hodgkin's Lymphoma (Group B) * Life expectancy of greater than or equal to 6 weeks * No severe intercurrent infection * Patient, parent/guardian able to give informed consent * Donor must be HIV negative (if autologous product used - patient must be HIV negative) * Bilirubin less than or equal to 3x normal * AST less than or equal to 5x normal * Hgb higher than 8.0 g/L * Creatinine less than or equal to 2x normal for age * Patients should have been off other investigational therapy including T cells therapies for one month prior to entry in this study * Karnofsky score of over or equal to 50 * No evidence of GVHD \>Grade II at time of enrollment * Female patients with reproductive capacity must have a negative pregnancy test Exclusion Criteria: * Patient, parent/guardian unable or unwilling to give informed consent * Pregnant women * Patients with a Karnofsky score of \< 50 * Patients with a severe intercurrent infection * Patients with a life expectancy of \<6 weeks * Patients with a bilirubin of more than 3x normal. AST of more than 5x normal * Patients with a creatinine of more than 2x normal for age * GVHD greater than Grade II at time of enrollment * Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom Note: Patients who would be excluded from the protocol strictly for laboratory abnormalities can be included at the investigator's discretion after approval by the CCGT Protocol Review Committee and the FDA reviewer.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receiving CTLs as therapy for relapsed Lymphoma or who are at high risk for relapse or patients receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. A fixed dose of CD45 MAb (400ug/kg over 4 hours daily times 4 given over 2 daily IV infusions) will be used.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Texas Children's Hospital

Houston, United StatesSee the location
Suspended

The Methodist Hospital

Houston, United States
Suspended2 Study Centers