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Virus Therapy

MABEL CTLs for EBV-Positive Lymphoma (MABEL Trial)

Phase 1
Recruiting
Led By Rayne H Rouce, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with the following diagnoses: EBV positive Hodgkin's lymphoma, EBV Positive non-Hodgkin's Lymphoma, EBV (associated)-T/NK-lymphoproliferative disease, Severe Chronic Active EBV (CAEBV), Other EBV positive malignancies
Patients with EBV positive tumor, weighing at least 12kg, with informed consent obtained from patient/guardian
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

MABEL Trial Summary

This trial will test whether or not special immune system cells can help treat cancer or lymph gland disease associated with the Epstein Barr Virus.

Who is the study for?
This trial is for individuals of any age or sex with certain EBV-positive cancers, such as Hodgkin's lymphoma, non-Hodgkin's lymphoma, and others. Participants must weigh at least 12kg, have a life expectancy of over 6 weeks, normal organ function tests, and be off other investigational therapies for 30 days. Pregnant or breastfeeding individuals and those on high-dose steroids or recent T cell antibodies are excluded.Check my eligibility
What is being tested?
The study is testing MABEL CTLs—special immune cells designed to fight cancer by targeting the Epstein-Barr Virus (EBV) in various malignancies. These cells come from healthy donors and are matched to patients' profiles. The trial also uses Cyclophosphamide and Fludarabine to prepare the body for MABEL CTL infusion.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune response against EBV-infected cells which could affect normal tissues causing symptoms like fever or fatigue; chemotherapy-related issues such as nausea; low blood counts leading to increased infection risk; organ inflammation; allergic reactions.

MABEL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is related to the Epstein-Barr virus.
Select...
My tumor is EBV positive, I weigh more than 12kg, and consent has been given.

MABEL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients with a dose-limiting toxicity (DLT)
Secondary outcome measures
percent of patients whose best response is either complete remission or partial remission

MABEL Trial Design

3Treatment groups
Experimental Treatment
Group I: Group C: MABEL CTLsExperimental Treatment3 Interventions
Patients with active disease if immunosuppressive chemotherapy is contraindicated. Three different dosing schedules will be evaluated. Two to four patients will be evaluated on each dosing schedule. Each patient will receive 2 injections, 14 days apart. If the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide (Cytoxan) and Fludarabine before s/he receives MABEL CTLs.
Group II: Group B: MABEL CTLsExperimental Treatment3 Interventions
Patients with persistent active disease despite therapy. Three different dosing schedules will be evaluated. Two to four patients will be evaluated on each dosing schedule. Each patient will receive 2 injections, 14 days apart. If the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide (Cytoxan) and Fludarabine before s/he receives MABEL CTLs.
Group III: Group A: MABEL CTLsExperimental Treatment3 Interventions
Patients with 1st or subsequent relapse. Three different dosing schedules will be evaluated. Two to four patients will be evaluated on each dosing schedule. Each patient will receive 2 injections, 14 days apart. If the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide (Cytoxan) and Fludarabine before s/he receives MABEL CTLs.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteOTHER
271 Previous Clinical Trials
80,333 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,210 Total Patients Enrolled
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
111 Previous Clinical Trials
2,775 Total Patients Enrolled

Media Library

MABEL CTLs (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02287311 — Phase 1
Epstein-Barr Virus Research Study Groups: Group C: MABEL CTLs, Group A: MABEL CTLs, Group B: MABEL CTLs
Epstein-Barr Virus Clinical Trial 2023: MABEL CTLs Highlights & Side Effects. Trial Name: NCT02287311 — Phase 1
MABEL CTLs (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02287311 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current capacity for participants in this trial?

"Affirmative. Clinicaltrials.gov data indicates that, from its original posting on February 1st of 2015 to its most recent update on January 5th 2022, this medical trial is actively recruiting 42 participants at 2 different sites."

Answered by AI

What risks are associated with MABEL CTLs for the individuals enrolled in this program?

"Limited clinical data exists for MABEL CTLs, so its safety rating falls at 1 on our scale."

Answered by AI

Are there other investigations utilizing MABEL CTLs?

"At present, there are 889 clinical trials analyzing MABEL CTLs with 161 of those in their terminal phase. Most studies related to this treatment occur within Philadelphia, Pennsylvania; however, 28443 other sites worldwide have also been designated for research purposes."

Answered by AI

Have recruitment efforts begun for this clinical experiment?

"According to current information hosted on clinicaltrials.gov, this research is actively recruiting participants and has been open for applications since February 1st 2015. The entry was last updated on May 1st 2022."

Answered by AI

What sorts of maladies have been treated with MABEL CTLs?

"MABEL CTLs are usually the drug of choice for those suffering from multiple sclerosis. Additionally, these same therapeutics have been successfully used to treat maladies such as acute and myelocytic leukemia, mixed-cell type lymphoma, and retinoblastoma."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Texas Children's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Most Closely Matched 3rd Party Rapidly Generated LMP, BARF1 And EBNA1 Specific CTL, EBV-Positive Lymphoma (MABEL)
Rayne Rouce 2015. "Most Closely Matched 3rd Party Rapidly Generated LMP, BARF1 And EBNA1 Specific CTL, EBV-Positive Lymphoma (MABEL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02287311.
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