Engineered immune cells take on virus-driven cancers in early trial
NCT ID NCT07306156
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment called GP350 CAR-T cells for people with blood cancers that are linked to the Epstein-Barr virus and have not responded to standard therapy. The treatment involves collecting a patient's own immune cells, modifying them to better target the cancer, and giving them back after a short course of chemotherapy. The goal is to see if the treatment can shrink tumors and clear the virus from the blood, while monitoring for side effects.
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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 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Nov 2032
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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Diagnosis: Confirmed diagnosis of lymphoid neoplasms according to WHO-HAEM5 (Alaggio R. et al. doi:10.1038/s41375-022-01620-2); 2. Disease Assessment: 1. Criteria for Relapsed/Refractory lymphoid neoplasms: Meeting any one of the following three conditions: ① Failure to achieve at least a partial response (PR) per Lugano criteria after two cycles of standard first-line therapy; ② Disease progression within six months after achieving a response to first-line therapy, or progression after six months with no response to the original first-line or second-line regimen; ③ Relapse after hematopoietic stem cell transplantation. 2. Criteria for EBV Infection: Meeting any one of the following three conditions: ① Peripheral blood (plasma or whole blood) EBV DNA load ≥ 10³ copies/ml by quantitative PCR; ②Tumor cell GP350 positivity (≥10% of tumor cells by immunohistochemistry or flow cytometry); ③ Serological detection of EBV antibodies indicating any of the following: positive anti-VCA-IgM; positive anti-EA-IgG; or simultaneous positivity for anti-VCA-IgM, anti-VCA-IgG, and anti-EBNA-IgG. 3. At least one evaluable lymphoma lesion according to Lugano criteria, or confirmed active lytic EBV infection. 3. Performance Status: ECOG score 0-2 and expected survival ≥3 months; 4. Age: 18-70 years, regardless of sex; 5. Hematologic Criteria: * Absolute neutrophil count (ANC) ≥1.0×10⁹/L; * Hemoglobin \>60 g/L; * CD3+ T-cell count \>0.5×10⁹/L; * Platelet count \>30×10⁹/L; 6. Organ Function: * Creatinine clearance ≥60 mL/min; * ALT/AST ≤2× upper limit of normal (ULN); * Total bilirubin ≤2× ULN; * Left ventricular ejection fraction (LVEF) ≥50%, no pericardial effusion, and no clinically significant ECG abnormalities; * Minimal or no pleural/ascitic fluid; * Oxygen saturation ≥95%; 7. Contraception: * Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception until the last follow-up; * Male participants with fertile partners must agree to use effective contraception until the last follow-up; 8. Informed Consent: Psychologically stable, capable of understanding the study's purpose and procedures, willing to participate voluntarily, and able to provide signed informed consent and comply with protocol requirements. Exclusion Criteria: 1. Active Infections: Presence of active hepatitis A, B, or C infection, or other uncontrolled severe active infections (excluding EBV infection); 2. Immunosuppression: * History of acquired immunodeficiency syndrome (AIDS); * Chronic use of immunosuppressants (including corticosteroids at doses equivalent to \>15 mg/day of prednisone) for other conditions; 3. Cardiac Dysfunction: 1. NYHA Class III or IV congestive heart failure; 2. Myocardial infarction or coronary artery bypass grafting within the past 6 months; 3. Clinically significant ventricular arrhythmia or unexplained syncope; 4. History of severe non-ischemic cardiomyopathy; 5. Cardiac insufficiency (left ventricular ejection fraction \<45%) within 8 weeks prior to apheresis; 4. Pregnancy/Contraception: * Pregnant or lactating women; * Participants (male or female) unwilling to use contraception; 5. Hepatic/Renal Impairment: * AST/ALT \>3× upper limit of normal (ULN); * Total bilirubin \>3× ULN; * Creatinine clearance \<60 mL/min; 6. Allergies: History of severe hypersensitivity to any study drugs; 7. Prior Stem Cell Transplant: Must have discontinued immunosuppressants for \>6 weeks post-transplant with no signs of graft-versus-host disease (GVHD); 8. Other Exclusionary Conditions: Any other condition deemed unsuitable by the investigator (e.g., coagulation disorders, hemolytic anemia, etc.).
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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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The Second Affiliated Hospital of Anhui Medical University
RECRUITINGHefei, Anhui, 230031, China
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