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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
GRALE Trial 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.Check my eligibility
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.See study design
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.
GRALE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
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My tumor is EBV positive.
GRALE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
T-Lymphocyte
Secondary outcome measures
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
GRALE 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.
Find a Location
Who is running the clinical trial?
The Methodist Hospital Research InstituteOTHER
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National Cancer Institute (NCI)NIH
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Baylor College of MedicineLead Sponsor
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tests show high levels of the EBV virus in my blood or tissues.My kidney function, measured by creatinine, is within twice the normal limit for my age.I agree to use effective birth control during and for 6 months after the study.My blood tests show normal bilirubin, AST levels, and hemoglobin above 7.0.I am eligible for a stem cell transplant for my lymphoma and will not use this study as an alternative.I am taking more than 0.5 mg/kg/day of corticosteroids.My tumor is or might be EBV positive.I haven't been on any experimental treatments for 4 weeks, except PD1/PDL inhibitors if needed.I can do most activities but may need help.You are pregnant or breastfeeding.I do not have a severe ongoing infection.My tumor is EBV positive.I do not have an active HIV, HTLV, HBV, or HCV infection.You weigh at least 26 pounds.I have EBV-positive lymphoma or a related EBV disease.
Research Study Groups:
This trial has the following groups:- Group 1: EBV-specific T cells: A
- Group 2: EBV-specific T cells: B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent would EBV-specific T cells: A be considered safe for human consumption?
"Our team has assessed the safety of EBV-specific T cells: A as a 1 due to this being a Phase 1 trial and hence, limited evidence for efficacy and safety."
Answered by AI
How many participants are currently enrolled in this medical trial?
"Affirmative, the info on clinicaltrials.gov suggests that this medical investigation is presently recruiting participants. This trial was first shared to the public on January 14th 2013 and its details were last revised June 28th 2022. The research team needs 136 patients from two different locations for their study."
Answered by AI
Are there slots available for enrolment in this clinical trial?
"Affirmative. According to information stored on clinicaltrials.gov, this medical investigation first opened its doors in January 14th 2013 and was last modified June 28th 2022. The study is presently searching for 136 volunteers at 2 distinct locations."
Answered by AI
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