New cell therapy targets EBV-Linked cancers in early trial
NCT ID NCT07450391
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study is testing an experimental cell therapy called EBV-AST for people with Epstein-Barr virus (EBV)-related lymphoproliferative disorders, including certain blood cancers and post-transplant complications. About 18 adults will receive up to 3 infusions of the treatment to check safety and find the best dose. The goal is to see if the therapy can shrink tumors and control the disease, but it is not expected to be a cure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Able to understand and voluntarily sign written informed consent. 2. Age 18 to 75 years, inclusive. 3. HLA genotype matches at least one of the following: HLA-A02:01, HLA-A11:01, or HLA-A\*24:02. 4. Karnofsky Performance Status (KPS) ≥ 70. 5. Life expectancy ≥ 3 months. 6. Diagnosed with EBV-associated lymphoproliferative disorders, including: 7. EBV infection-associated post-transplant lymphoproliferative disorder (PTLD) that is relapsed/refractory after at least first-line standard therapy; or 8. EBV-associated lymphoma confirmed by histology and/or cytology with EBER positivity (ISH/FISH), with no standard treatment available or not suitable for standard therapy, including but not limited to: EBV-positive DLBCL, EBV-positive NK/T-cell lymphoma, EBV-positive Hodgkin lymphoma, EBV-positive Burkitt lymphoma, EBV-positive nodal TFH lymphoma (AITL type), and EBV-positive primary cutaneous T-cell lymphoma, meeting protocol-defined relapsed/refractory criteria. 9. Absolute lymphocyte count ≥ 0.8 × 10\^9/L (except for PTLD participants). 10. Adequate organ and bone marrow function per protocol-defined criteria. 11. Participants of childbearing potential agree to use highly effective contraception throughout the study; women of childbearing potential must have a negative pregnancy test at screening. Exclusion Criteria: 1. Known hypersensitivity to the investigational product or its components. 2. Uncontrolled active graft-versus-host disease (GVHD) in PTLD participants. 3. Known primary immunodeficiency disorders (e.g., X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, chronic granulomatous disease, hyper-IgE syndrome). 4. Severe uncontrolled medical conditions that, in the investigator's judgment, make the participant unsuitable for enrollment. 5. Serious cardiac disease within 6 months prior to first infusion (e.g., myocardial infarction, severe/unstable angina, bypass surgery, NYHA class III-IV heart failure). 6. Chronic diseases requiring systemic immunosuppressants or systemic steroids (except local/inhaled steroids or physiologic replacement therapy). 7. History of other malignancy within the past 5 years, except carcinoma in situ (e.g., cervix, bladder, breast) or non-melanoma skin cancer. 8. Receipt of lymphocyte-based immunotherapy (e.g., CIK, DC, DC-CIK, LAK) within 3 months prior to consent. 9. Receipt of interferon or other targeted immunodeficiency drugs within 3 months prior to consent; prior high-dose IL-2 therapy. 10. Anti-cancer therapy within 14 days prior to consent (including chemotherapy or immunosuppressants/steroids); other cell therapy or live vaccines/attenuated vaccines or other investigational drugs within 28 days prior to consent; curative radiotherapy or major surgery within 4 weeks, or palliative local radiotherapy within 2 weeks prior to consent. 11. Prior immune therapy-associated ≥ Grade 3 immune-related adverse events (irAEs). 12. Unresolved toxicity from prior therapy \> Grade 1 (except alopecia any grade; peripheral sensory neuropathy ≤ Grade 2). 13. Uncontrolled psychiatric or neurologic disorders; drug abuse or alcohol dependence. 14. Positive HIV antibody; positive Treponema pallidum antibody; active hepatitis B (HBsAg and/or HBeAg positive with HBV-DNA above ULN) or active hepatitis C (HCV-Ab positive and HCV-RNA positive). 15. Uncontrolled severe active infection or contagious disease (excluding EBV infection). 16. Pregnant or breastfeeding women.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chinese PLA General Hospital
RECRUITINGBeijing, Beijing Municipality, 100853, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New vaccine aims to fight Hard-to-Treat EBV cancers
- New hope for hard-to-treat lymphoma: three-drug combo enters early trials
- New antibody shows promise against Post-Transplant virus threat
- Engineered immune cells take aim at stubborn lymphoma
- Supercharged t cells take on Hard-to-Treat lymphoma
- New drug cocktail targets Virus-Linked cancers in early trial