Differential antibody response to EBV proteome following EBVST immunotherapy in EBV-associated lymphomas.
Yomani D Sarathkumara, Nathan W Van Bibber, Zhiwei Liu...
https://pubmed.ncbi.nlm.nih.gov/39908567Actively Recruiting
Phase 1
All Genders
ID01555892
Administration of Rapidly Generated EBV-Specific Cytotoxic T-Lymphocytes to Patients With EBV-Positive Lymphoma
Led by Baylor College of Medicine · Updated on 2026-03-02
136
Participants Needed
3
Research Sites
17 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
T
The Methodist Hospital Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the use of specially trained immune cells called GRALE T cells for patients with certain types of lymph gland diseases, including Hodgkin's Disease, Non-Hodgkin's Lymphoma, T/NK-lymphoproliferative disease, or severe chronic active Epstein Barr Virus (CAEBV). These diseases either have returned, are at risk of returning, or have not responded to previous treatments. The study focuses on patients whose tumors show the Epstein Barr virus, which can hide from the immune system and may contribute to these cancers. Researchers want to see if GRALE T cells can survive in the blood and impact the tumor. Participants or their donors will provide blood to grow EBV-specific GRALE T cells in the lab. Some patients may receive chemotherapy drugs cyclophosphamide and fludarabine to prepare their blood for the T cells. The GRALE T cells will be thawed and infused into patients over a few minutes, with two doses given two weeks apart. If there is a partial response or stable disease after these doses, patients may receive up to six additional infusions. Treatments are given at specialized centers, and patients may or may not receive chemotherapy to help the T cells grow. Throughout the study, participants will have scans and blood tests to assess tumor size and immune response. After infusions, patients will be followed regularly—every three months for a year, then yearly for up to five years—to monitor safety and effectiveness. The main outcome is to determine the highest safe dose of these T cells and observe side effects. Researchers will also study how well the T cells survive and their anti-viral and anti-tumor effects over one year.
CONDITIONS
Brief Title
Cytotoxic T-Lymphocytes for EBV-positive Lymphoma, GRALE
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Patients of any age or sex with EBV-positive Hodgkin's or Non-Hodgkin's Lymphoma, EBV-associated T/NK-lymphoproliferative disease, or severe chronic active EBV (CAEBV)
- EBV-positive tumor (may be pending at the time of screening)
- Weighs at least 12 kilograms
- Informed consent explained, understood, and signed by patient or guardian
- At time of infusion, must be in second or subsequent relapse or first relapse with contraindications to immunosuppressive chemotherapy, or in remission or with minimal residual disease after autologous or syngeneic stem cell transplant
- Liver function within specified limits (bilirubin ≤3x upper limit, AST ≤5x upper limit)
- Hemoglobin ≥7.0 (may be transfused value)
- Kidney function within specified limits (creatinine ≤2x upper limit)
- Pulse oximetry >90% on room air
- Off other investigational therapy for at least 4 weeks prior (PD1/PDL inhibitors allowed if medically indicated)
- Karnofsky/Lansky performance score ≥50
- Sexually active patients must agree to use effective birth control during study and for 6 months after
You will not qualify if you...
- Active infection with HIV, HTLV, HBV, or HCV (may be pending at screening)
- Pregnant or lactating at time of infusion
- Severe intercurrent infection at time of infusion
- Current use of systemic corticosteroids greater than 0.5 mg/kg/day
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 4 weeks
Participants receive two infusions of EBV-specific cytotoxic T-lymphocytes 14 days apart. Some participants may receive chemotherapy drugs cyclophosphamide and fludarabine intravenously daily for three days before the T-cell infusions to prepare the body.
2 infusions 2 weeks apart; chemotherapy given daily over 3 days if applicable
Follow-up
Duration - Up to 5 years after last infusion
Participants are followed up with clinic visits or yearly contacts by a research nurse for up to 5 years after the last infusion to monitor health and response to treatment. For those receiving additional infusions, follow-up occurs every 3 months until 12 months after the last infusion, then yearly thereafter.
Clinic visits or yearly contacts; every 3 months follow-up for 1 year after additional infusions
Trial Site Locations
Total: 3 locations
1
Harris Health System (includes ben Taub General Hospital and Smith)
Houston, Texas, United States, 77030
Not Yet Recruiting
2
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
3
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
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Research Team
H
Helen E Heslop, MD
V
Vicky Torrano
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Cotargeting EBV lytic as well as latent cycle antigens increases T-cell potency against lymphoma.
Sandhya Sharma, Naren U Mehta, Tim Sauer...
https://pubmed.ncbi.nlm.nih.gov/38640255