GP350 CAR-T for Relapse/Refractory and Epstein-Barr Virus Infection Associated Lymphoid Neoplasms

Официальное название

GP350 CAR-T Cells for Relapse/Refractory and Epstein-Barr Virus Infection Associated Lymphoid Neoplasms, an Open-label, Single-arm Clinical Trial

Обзор

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

Вмешательства

• Биопрепарат GP350 CAR-T
  Lymphodepletion chemotherapy with fludarabine (25 mg/m²/day) and cyclophosphamide (250 mg/m²/day) should be administered for 2-3 consecutive days, with the final dose completed 48 hours before infusion. Alternatively, investigators may individualize this regimen based on the subject's specific clinical circumstances. The target dose of GP350 CAR-T cells is 1.0-5.0×10⁶ CAR-T cells per kilogram of body weight, administered via intravenous injection. (The actual infused dose is allowed to vary with

Первичные конечные точки

• Overall Response Rate (ORR) [Срок оценки: Month 12 post CAR-T infusion]
• EBV DNA clearance rate [Срок оценки: Month 12 post CAR-T infusion]
• Treatment Emergent Adverse Event (TEAE) [Срок оценки: Within 3 months post-infusion]

Вторичные конечные точки (2)

• Progression-Free Survival (PFS) [Срок оценки: 1 yesr post CAR-T infusion]
• Overall Survival (OS) [Срок оценки: 1 yesr post CAR-T infusion]

Критерии участия

Критерии включения

• Diagnosis: Confirmed diagnosis of lymphoid neoplasms according to WHO-HAEM5 (Alaggio R. et al. doi:10.1038/s41375-022-01620-2);
• Disease Assessment:

• 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.
• 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.
• At least one evaluable lymphoma lesion according to Lugano criteria, or confirmed active lytic EBV infection.
• Performance Status: ECOG score 0-2 and expected survival ≥3 months;
• Age: 18-70 years, regardless of sex;
• 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;
• 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%;
• 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;
• 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.

Критерии исключения

• Active Infections: Presence of active hepatitis A, B, or C infection, or other uncontrolled severe active infections (excluding EBV infection);
• 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;
• Cardiac Dysfunction:

• NYHA Class III or IV congestive heart failure;
• Myocardial infarction or coronary artery bypass grafting within the past 6 months;
• Clinically significant ventricular arrhythmia or unexplained syncope;
• History of severe non-ischemic cardiomyopathy;
• Cardiac insufficiency (left ventricular ejection fraction <45%) within 8 weeks prior to apheresis;
• Pregnancy/Contraception:

• Pregnant or lactating women;
• Participants (male or female) unwilling to use contraception;
• Hepatic/Renal Impairment:

• AST/ALT >3× upper limit of normal (ULN);
• Total bilirubin >3× ULN;
• Creatinine clearance <60 mL/min;
• Allergies: History of severe hypersensitivity to any study drugs;
• Prior Stem Cell Transplant: Must have discontinued immunosuppressants for >6 weeks post-transplant with no signs of graft-versus-host disease (GVHD);
• Other Exclusionary Conditions: Any other condition deemed unsuitable by the investigator (e.g., coagulation disorders, hemolytic anemia, etc.).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Anhui Medical University — Хэфэй

Идентификаторы

NCT: NCT07306156 · TXB2025-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗