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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

Must not have

Patients receiving ATG, Campath, or other immunosuppressive T cell monoclonal antibodies within 30 days

Current use of systemic corticosteroids more than 0.5 mg/kg/day

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is related to the Epstein-Barr virus.

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My tumor is EBV positive, I weigh more than 12kg, and consent has been given.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not received ATG, Campath, or similar immune-targeting drugs in the last 30 days.

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I am taking more than 0.5 mg/kg/day of corticosteroids.

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I am currently suffering from a severe infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients with a dose-limiting toxicity (DLT)

Secondary study objectives

percent of patients whose best response is either complete remission or partial remission

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2010

Completed Phase 4

~2310

Fludarabine

2012

Completed Phase 4

~1860