NCT07306156招募中1 期
GP350 CAR-T Cells for Relapse/Refractory and Epstein-Barr Virus Infection Associated Lymphoid Neoplasms, an Open-label, Single-arm Clinical Trial
Zhimin Zhai1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年11月10日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- EBV DNA clearance rate
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.).
研究组 & 干预措施
CAR-T Treatment
Experimental
干预措施: GP350 CAR-T (Biological)
结局指标
主要结局
EBV DNA clearance rate
时间窗: Month 12 post CAR-T infusion
Defined as the proportion of patients achieving two consecutive negative tests in plasma or whole blood at least 7 days apart following treatment, relative to the total treated population
Overall Response Rate (ORR)
时间窗: Month 12 post CAR-T infusion
The percentage of patients with complete response (CR) and partial response (PR) according to the RECIL 2017 criteria determined by the study investigators
Treatment Emergent Adverse Event (TEAE)
时间窗: Within 3 months post-infusion
TEAE is defined as an adverse event that occurs or worsens after receiving the first dose of the trial drug
次要结局
- Progression-Free Survival (PFS)(1 yesr post CAR-T infusion)
- Overall Survival (OS)(1 yesr post CAR-T infusion)
研究者
Zhimin Zhai
Chief of Hematology Department
The Second Hospital of Anhui Medical University
研究点 (1)
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