肿瘤细胞治疗研究
英文原题：An Open and Dose-escalation Early Clinical Study of CD19 and CD20 CAR-T Cell Therapy for Relapsed or Refractory Aggressive B-cell Lymphoma
这是一项早期 I 期注册临床试验，评估细胞治疗用于 B 细胞淋巴瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 18 例。试验地点：中国 · 北京（共 1 个中心，其中中国 1 个）。登记号：NCT07344818。
不限性别 · ≥ 18 Years
纳入标准：
1. 受试者或其法定监护人能够理解并自愿签署知情同意书（ICF）。
2. 签署ICF时年龄≥18岁的男性或女性受试者。
3. 预期生存期至少12周。
4. 签署ICF时ECOG体能状态评分为0-2。
5. 签署ICF时诊断为复发或难治性侵袭性B细胞淋巴瘤。受试者必须既往接受过含蒽环类药物的化疗和利妥昔单抗（或其他CD20靶向药物）治疗，且在接受至少两线既往治疗或自体造血干细胞移植（ASCT）后出现复发或进展。
6. 根据Lugano标准存在可测量的阳性病灶。
7. 活检至筛选期确认淋巴瘤病灶表达CD19和/或CD20。
8. 主要器官功能充足。
9. 避孕。
排除标准：
1. 仅累及中枢神经系统（CNS）的淋巴瘤（继发性CNS淋巴瘤除外）。
2. 有CNS疾病史。
3. 签署ICF前4周内有需要全身免疫抑制治疗的自身免疫性疾病史。
4. 签署ICF时或白细胞采集前2周内存在任何未控制的的活动性感染，需要抗生素、抗病毒或抗真菌治疗。
5. 活动性感染证据，包括：HBV DNA、抗HCV抗体阳性且HCV RNA可检测、HIV抗体阳性、巨细胞病毒（CMV）DNA阳性、EB病毒（EBV）DNA阳性、梅毒螺旋体特异性及非特异性血清学试验均阳性。
6. 有临床意义的心血管疾病。
7. 已知对本研究中所用研究产品的任何成分过敏。
8. 在白细胞采集前及药物5个半衰期内接受过任何疾病相关研究性治疗或其他全身抗肿瘤治疗。
9. 签署ICF前2周内、白细胞采集前2周内或研究期间需要全身性皮质类固醇（剂量相当于泼尼松≥20 mg/天）或其他免疫抑制剂。
10. 签署ICF前4周内接受过大手术（常规活检除外），或研究期间计划接受大手术。
11. 签署ICF前5年内有其他原发性恶性肿瘤史，但以下情况除外：
1. 经充分治疗并治愈的宫颈原位癌；
2. 局限性皮肤基底细胞癌或鳞状细胞癌。
12. 签署ICF前4周内接种过减毒活疫苗，或筛选期计划接种减毒活疫苗。
13. 研究者认为可能影响方案依从性或使受试者不适合参加研究的任何状况或并发症。
14. 妊娠或哺乳期女性。
Inclusion Criteria:
1. The subject or his/her legal guardian is able to understand and voluntarily sign the informed consent form (ICF).
2. Male or female subjects aged ≥18 years at the time of signing the ICF.
3. An expected life expectancy of at least 12 weeks.
4. An ECOG performance status of 0-2 at the time of signing the ICF.
5. A diagnosis of relapsed or refractory aggressive B-cell lymphoma at the time of signing the ICF. Subjects must have previously received treatment with anthracycline-containing chemotherapy and rituximab (or other CD20-targeted agents), and must have experienced relapse or progression after at least two prior lines of therapy or autologous hematopoietic stem cell transplantation (ASCT).
6. Presence of measurable positive lesions as defined by the Lugano criteria.
7. Lymphoma lesions confirmed by biopsy to screening demonstrating expression of CD19 and/or CD20.
8. Adequate major organ function.
9. contraception.
Exclusion Criteria:
1. Lymphoma involving only the central nervous system (CNS) (except for secondary CNS lymphoma).
2. History of CNS disorders.
3. History of autoimmune disease requiring systemic immunosuppressive therapy within 4 weeks prior to signing the ICF.
4. Presence of any uncontrolled active infection at the time of signing the ICF or within 2 weeks prior to leukapheresis, requiring antibiotic, antiviral, or antifungal treatment.
5. Evidence of active infection, including: HBV DNA、Positive anti-HCV antibody with detectable HCV RNA、Positive HIV antibody、Positive cytomegalovirus (CMV) DNA、Positive Epstein-Barr virus (EBV) DNA、Positive both treponemal-specific and non-specific serologic tests for syphilis.
6. Clinically significant cardiovascular disease.
7. Known hypersensitivity to any component of the investigational products used in this study.
8. Receipt of any disease-related investigational therapy or other systemic antitumor therapy prior to leukapheresis and within 5 half-lives of the drug.
9. Requirement for systemic corticosteroids (at a dose equivalent to ≥20 mg/day of prednisone) or other immunosuppressive agents within 2 weeks prior to signing the ICF, within 2 weeks prior to leukapheresis, or during the study.
10. Major surgery (excluding routine biopsy) within 4 weeks prior to signing the ICF, or planned major surgery during the study period.
11. History of another primary malignancy within 5 years prior to signing the ICF, except for:
1. Adequately treated and cured carcinoma in situ of the cervix;
2. Localized basal cell carcinoma or squamous cell carcinoma of the skin.
12. Receipt of a live attenuated vaccine within 4 weeks prior to signing the ICF, or planned vaccination with a live attenuated vaccine during the screening period.
13. Any condition or complication that, in the investigator's opinion, may affect protocol compliance or make the subject unsuitable for participation in the study.
14. Pregnant or breastfeeding women.以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：the safety of CD19⁺CD20 CAR-T therapy · To evaluate the incidence and severity of AEs and SAEs in the treatment of relapsed or refractory CD19 and/or CD20 positive aggressive B-cell lymphoma patients after infused the CD19+CD20 CAR-T cells · 1 year after CAR-T cells therapy
符合条件的患者将接受CD19+CD20双靶点CAR-T细胞治疗
观察双靶点嵌合抗原受体T细胞治疗难治性或复发性侵袭性B细胞淋巴瘤的疗效和安全性
To observe the efficacy and safety of dual-target chimeric antigen receptor T cells in the treatment of refractory or relapsed aggressive B-cell lymphoma
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