💬In plain words
What the trial is, and whether it could suit you
This is a Phase 1/Phase 2 open-label, single-arm clinical study of GP350 CAR-T for Relapse/Refractory and Epstein-Barr virus infection associated lymphoid neoplasms.
Each participant will undergo leukapheresis after enrolment, receive treatment of the conditioning chemotherapy, and an intravenous infusion of CAR-T cells.
Each participant will proceed through the following study procedures:
* Screening
* Enrollment/Leukapheresis
* Conditioning chemotherapy
* CAR T treatment
* Post-treatment assessment
* Long-term follow-up
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.).