← Back to Search

CAR T-cell Therapy

EBV-Specific Cytotoxic T-Lymphocytes for Lymphoma (GRALE Trial)

Phase 1

Recruiting

Led By Helen E Heslop, 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

Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non-Hodgkin's Lymphoma (regardless of histologic subtype), or EBV (associated)-T/NK-lymphoproliferative disease or Severe Chronic Active EBV (CAEBV)* and In second or subsequent relapse (or first relapse or with active disease if immunosuppressive chemotherapy contraindicated or multiply relapsed patients in remission who have a high risk of relapse)** OR any patient with primary disease or in first remission if immunosuppressive chemotherapy is contraindicated, e.g. patients who develop Hodgkin disease after solid organ transplantation or if the Lymphoma is a second malignancy e.g. a Richter's transformation of CLL. (Group A) OR In remission or with minimal residual disease status after autologous or syngeneic SCT. (Group B)

CAEBV is defined as patients with high EBV viral load in plasma or PBMC (> 4000 genomes per ug PBMC DNA) and/or biopsy tissue positive for EBV

Must not have

Current use of systemic corticosteroids > 0.5 mg/kg/day

Severe intercurrent infection.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is for people with Hodgkin or non-Hodgkin lymphoma, T/NK-lymphoproliferative disease, or severe chronic active Epstein Barr Virus (CAEBV) that has come back or is at risk of coming back.

Who is the study for?

This trial is for individuals of any age or sex with EBV-positive Hodgkin's or non-Hodgkin's Lymphoma, T/NK-lymphoproliferative disease, or severe chronic active Epstein Barr Virus (CAEBV). They must have a life expectancy of at least 6 weeks, stable organ function, and be willing to use effective birth control. It excludes those with HIV/HTLV/HBV/HCV infections, pregnant/lactating women, high-dose steroid users, and patients with severe infections.

What is being tested?

The study tests GRALE T cells designed to fight EBV-infected cells in lymphoma patients. The goal is to determine the highest safe dose of these lab-made T cells using a new technique and assess their side effects and potential benefits against HD/NHL/EBV-related diseases.

What are the potential side effects?

While specific side effects are not listed here, similar therapies can cause immune reactions like fever or fatigue; infusion reactions; possible damage to organs targeted by the immune response; increased risk of infection due to immune system modification.

Eligibility Criteria

Inclusion Criteria

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

Select...

My tests show high levels of the EBV virus in my blood or tissues.

Select...

My kidney function, measured by creatinine, is within twice the normal limit for my age.

Select...

My blood tests show normal bilirubin, AST levels, and hemoglobin above 7.0.

Select...

I am eligible for a stem cell transplant for my lymphoma and will not use this study as an alternative.

Select...

I can do most activities but may need help.

Select...

My tumor is EBV positive.

Exclusion Criteria

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

Select...

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

Select...

I do not have a severe ongoing infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

T-Lymphocyte

Secondary study objectives

Assess anti-viral and anti-tumor effects of LMP/BARF1/EBNA1-specific EBVST

Determine survival and immune function of LMP/BARF1/EBNA1-specific cytotoxic T-lymphocyte lines

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: EBV-specific T cells: BExperimental Treatment1 Intervention

Group B: Patients in remission or with minimal residual disease (MRD) status after autologous or syngeneic SCT. Patients will be treated at Dose Level 3. Each patient will receive 2 injections, 14 days apart, according to the following dosing schedule: Day 0: 1 x 10\^8 cells/m2 Day 14: 2 x 10\^8 cells/m2

Group II: EBV-specific T cells: AExperimental Treatment1 Intervention

Group A: Patients in second or subsequent relapse (or first relapse or with active disease if immunosuppressive chemotherapy contraindicated or multiple relapsed patients in remission who are at a high risk of relapse)\*\* or any patient with primary disease or in first or subsequent remission if immunosuppressive chemotherapy is contraindicated. Patients will be treated at Dose Level 3. Each patient will receive 2 injections, 14 days apart, according to the following dosing schedule: Day 0: 1 x 10\^8 cells/m2 Day 14: 2 x 10\^8 cells/m2 \*\* Patients with relapsed or refractory lymphoma that are eligible for a stem cell transplant will not be treated on this study as an alternative to transplant.

0 / 9Eligibility criteria met