肿瘤细胞治疗研究
英文原题：Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma
这是一项 I 期注册临床试验，评估细胞治疗用于弥漫大 B 细胞淋巴瘤、非霍奇金淋巴瘤、滤泡性淋巴瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 20 例。试验地点：美国 · 杜阿尔特、芝加哥、纽约、布朗克斯（共 7 个中心）。登记号：NCT05077527。
不限性别 · ≥ 18 Years
纳入标准：
* 受试者在签署知情同意书时年龄 >= 18 岁。由于目前尚无 axicabtagene ciloleucel 在 < 18 岁受试者中使用的给药或不良事件数据，因此儿童被排除在本研究之外
* 受试者能够理解并愿意在任何研究程序之前签署书面知情同意文件
* 受试者必须患有以下组织学类型的 R/R 侵袭性 B 细胞 NHL：
* 弥漫性大 B 细胞淋巴瘤（DLBCL，包括由惰性组织学转化而来）
* 高级别 B 细胞淋巴瘤
* 原发性纵隔 B 细胞淋巴瘤
* 滤泡性淋巴瘤，3B 级
* 受试者必须接受过蒽环类药物和利妥昔单抗（或其他 CD20 靶向药物）治疗，并且在至少 2 线治疗后仍为 R/R 疾病
* 在受试者提供知情同意时，距任何既往全身性癌症治疗必须已过去至少 2 周或 5 个半衰期，以较短者为准
* 可评估疾病为以下任一情况：
* 根据《霍奇金和非霍奇金淋巴瘤初始评估、分期和疗效评估建议：Lugano 分类》，正电子发射断层扫描（PET）阳性疾病，或
* 通过骨髓活检评估的骨髓受累
* 东部肿瘤协作组 ECOG 体能状态 =< 1（Karnofsky >= 60%）
* 血清肌酐 =< 1.5 x 年龄校正的正常值上限（ULN）或计算的肌酐清除率（Cockcroft 和 Gault）> 30 mL/min/1.73 m^2（入组前 4 周内）
* 丙氨酸氨基转移酶（ALT）=< 5 x ULN 且总胆红素 < 2.0 mg/dL（或对于患有 Gilbert 综合征或肝脏淋巴瘤浸润的受试者，或如果正在服用阿扎那韦或茚地那韦，则 < 3.0 mg/dL）（入组前 4 周内）
* 肺功能充分，定义为 =< 不良事件通用术语标准（CTCAE）1 级呼吸困难，且室内空气中氧饱和度（SaO2）>= 92%（入组前 4 周内）
* 心功能充分，定义为在确定合格性后 1 个月内通过超声心动图或多门控采集（MUGA）扫描评估的左心室射血分数（LVEF）>= 40%
* 中性粒细胞绝对计数：>= 1,000/mm^3（入组前 4 周内）
* 血小板：>= 75,000/mm^3（入组前 4 周内）
* 总胆红素：=< 1.5 x 机构正常值上限（ULN）（Gilbert 综合征患者为 3.0 x ULN）然而，如果认为胆红素升高继发于抗逆转录病毒治疗，则总胆红素必须 =< 3.5 mg/dL，前提是直接胆红素正常且天冬氨酸氨基转移酶（AST）和 ALT =< 3 x 正常值上限（入组前 4 周内）
* 有足够的血管通路用于白细胞分离术程序和细胞产品的给药（外周管路或白细胞分离导管均可）
* 既往接受过CD19靶向治疗的患者，必须自完成既往CD19靶向治疗后的活检确认CD19阳性淋巴瘤
* axicabtagene ciloleucel对发育中的人类胎儿的影响尚不清楚。因此，有生育能力的女性和男性必须同意在研究入组前、整个研究参与期间以及axicabtagene ciloleucel末次给药后12个月内采用充分的避孕措施（激素或屏障法避孕；禁欲）。如果女性在她或其伴侣参与本研究期间怀孕或怀疑怀孕，她应立即告知其主治医生
* 有生育能力伴侣的男性必须同意在研究入组前、整个研究参与期间以及axicabtagene ciloleucel末次给药后1年内采用有效的屏障避孕方法
* 通过以下任一方式记录的HIV-1感染：
* 由持证医疗保健研究者通过病历记录的HIV诊断；
* 由持证医疗保健研究者记录的接受抗逆转录病毒治疗（ART）（至少两种不同的药物，且不构成暴露前预防[PrEP]处方）的记录。记录可以是参与者病历中的ART处方记录、以参与者名义开具的ART书面处方，或带有显示参与者姓名的标签的ART药瓶；
* 通过持证HIV-1 RNA检测法检测到HIV-1核糖核酸（RNA），显示>1000 RNA拷贝/mL；
* 任何联邦批准、持证的HIV筛查抗体和/或HIV抗体/抗原联合检测，并经第二种持证HIV检测确认，如HIV-1 Western blot确认或HIV快速多斑点抗体鉴别检测。注：“持证”检测指美国食品药品监督管理局（FDA）批准的检测，所有新药临床研究（IND）研究均要求使用该检测
* 注册前4周内通过FDA批准的检测法测得HIV病毒载量低于50拷贝/mL
* 必须在入组前4周内在任何具有临床实验室改进修正案（CLIA）认证或其等效认证的美国实验室获取CD4细胞计数。将研究二十名参与者，目标是至少入组6名CD4 <100 cells/uL的参与者
* 患有丙型肝炎（抗-HCV抗体反应性）和乙型肝炎（HBsAg阳性和/或抗-HBc-Total阳性）的参与者可入组，前提是总胆红素 =< 1.5 x 机构正常上限（ULN），AST（血清谷草转氨酶[SGOT]）和ALT（血清谷丙转氨酶[SGPT]）必须 =< 3 X 机构正常上限，且入组前4周内HBV脱氧核糖核酸（DNA）<100 IU/mL（如果乙型肝炎阳性）。必须不存在肝硬化的证据
* 乙型肝炎核心抗体阳性的参与者必须在整个研究期间使用抗病毒药物抑制乙型肝炎，并愿意在axicabtagene输注后继续治疗至少一年
* 愿意在白细胞分离术、生产、输注及axicabtagene ciloleucel输注后继续ART的参与者
排除标准：
* 研究者认为极有可能从自体移植中获得临床获益的参与者
* 恶性肿瘤仅累及中枢神经系统（CNS）的参与者（注：允许有继发性CNS受累的参与者入组研究
* 既往或并发第二种恶性肿瘤，且研究者认为其自然病程或治疗过程有可能干扰研究方案的安全性 或疗效评估的参与者
* 在预期白细胞分离术前6个月内接受过阿仑单抗治疗，或在预期白细胞分离术前3个月内接受过氟达拉滨或克拉屈滨治疗
* 入组时尽管接受了适当的抗生素或其他治疗，仍存在未控制的全身性真菌、细菌、病毒或其他感染的参与者
* 存在急性或慢性移植物抗宿主病
* 过去6个月内存在以下任一心血管疾病史：纽约心脏协会定义的III级或IV级心力衰竭、心脏血管成形术或支架置入术、心肌梗死、不稳定型心绞痛或其他具有临床意义的心脏疾病
* 存在或曾有临床相关的中枢神经系统病变，如癫痫、惊厥、瘫痪、失语、卒中、严重脑损伤、痴呆、帕金森病、小脑疾病、器质性脑综合征或精神病
* 妊娠或哺乳期女性。注：有生育潜力的女性必须在开始预处理化疗前48小时内进行血清妊娠试验且结果为阴性。妊娠女性被排除在本研究之外，因为axicabtagene ciloleucel尚未在妊娠女性中进行研究。由于母亲接受axicabtagene ciloleucel治疗后对哺乳婴儿存在未知但潜在的不良事件风险，如果母亲接受axicabtagene ciloleucel治疗，应停止母乳喂养。这些潜在风险也可能适用于本研究中使用的其他药物
* 使用以下药物：
* 在白细胞分离术前7天内或axicabtagene ciloleucel给药前72小时内使用治疗剂量的皮质类固醇（定义为> 20 mg/天泼尼松或等效剂量）。允许使用生理替代剂量、局部和吸入性类固醇
* 白细胞分离术后为维持疾病控制而给予的化疗必须在预处理化疗前至少7天停止
* 在白细胞分离术前1周内使用过不被视为淋巴毒性（见下文）的细胞毒性化疗药物。口服化疗药物，包括来那度胺和依鲁替尼，如果在白细胞分离术前已过至少3个半衰期，则允许使用
* 在白细胞分离术前2周内使用过淋巴毒性化疗药物（例如，环磷酰胺、异环磷酰胺、苯达莫司汀）
* 在白细胞分离术前4周内接受过试验性药物，除非在试验性治疗期间记录到无缓解或疾病进展，且在白细胞分离术前已过至少3个半衰期
* 在白细胞分离术和axicabtagene ciloleucel给药前4周内使用过免疫抑制治疗（例如，钙调神经磷酸酶抑制剂、甲氨蝶呤或其他化疗药物、霉酚酸酯、雷帕霉素、沙利度胺、免疫抑制抗体如抗TNF、抗IL6或抗IL6R）
* 在axicabtagene ciloleucel给药前6周内接受过供者淋巴细胞输注（DLI）
* 在白细胞分离术前1周内接受过放疗。受试者必须存在照射病灶的疾病进展，或具有额外的未照射、PET阳性病灶，方符合资格。然而，如果存在额外的未照射PET阳性病灶，对单个病灶的姑息性放疗允许在白细胞分离术前最多2周内进行
* 既往接受过CAR T细胞治疗
* 具有提示活动性CNS受累的体征或症状的参与者被排除于本方案之外，以下例外情况除外：以下患者被纳入本方案：
* 既往接受过淋巴瘤或白血病CNS受累治疗，且在白细胞分离术前2周内通过全脊柱和脑钆增强磁共振成像（MRI）无神经系统症状且无CNS活动性淋巴瘤或白血病证据，并且在axicabtagene ciloleucel（axi-cel）输注前无神经系统进展的参与者
* 具有活动性CNS受累且在白细胞分离术前至少3周神经系统症状稳定，并且在axi-cel输注前无神经系统进展的参与者。这些患者应在axi-cel输注前5天内通过全脊柱和脑钆增强MRI进行评估，以记录axi-cel输注前CNS疾病的范围。如果既往阳性，还应在axi-cel输注后5天内包括脑脊液（CSF）采样用于细胞计数、细胞学和通过流式细胞术检测细胞标志物
* 在无活动性自身免疫性疾病的情况下，允许使用吸入性或局部用类固醇以及肾上腺替代剂量 ≤ 10 mg/日泼尼松等效剂量。参与者允许使用局部、眼部、关节内、鼻内和吸入性皮质类固醇（全身吸收极少）。允许使用生理替代剂量的全身性皮质类固醇，包括 ≥ 10 mg/日泼尼松等效剂量。允许短期使用皮质类固醇用于预防（例如，造影剂过敏）或治疗非自身免疫性疾病（例如，接触性过敏原引起的迟发型超敏反应）。允许使用合成代谢类固醇
* 参与者尚未从既往所有治疗所致的毒性恢复至基线或 CTCAE ≤ 1 级，但 ≤ 2 级脱发、神经病变及其他无临床显著意义的不良事件（AE）除外，前提是满足所有其他合格性标准
* 过去 3 个月内发生机会性感染，口咽部念珠菌病除外
* 有归因于与 axicabtagene ciloleucel 或研究中使用的其他药物具有相似化学或生物学组成成分的化合物的过敏反应史
* 未控制的并发疾病，包括但不限于持续或活动性感染，或可能限制对研究要求依从性的精神疾病
Inclusion Criteria:
* Participant with age \>= 18 years at the time of consent. Because no dosing or adverse event data are currently available on the use of axicabtagene ciloleucel in participants \< 18 years of age, children are excluded from this study
* Participant is able to understand and willing to sign a written informed consent document before any study procedures
* Participant must have R/R aggressive B-cell NHL of the following histologies:
* Diffuse large B-cell lymphoma (DLBCL, including transformed from indolent histology)
* High-grade B-cell lymphoma
* Primary mediastinal B-cell lymphoma
* Follicular lymphoma, grade 3B
* Participant must have been treated with an anthracycline and rituximab (or other CD20-targeted agent) and have R/R disease after at least 2 lines of therapy
* At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic cancer therapy at the time the subject provides consent
* Evaluable disease as either:
* Positron emission tomography (PET)-positive disease according to the "Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification", or
* Bone marrow involvement assessed by bone marrow biopsy
* Eastern Cooperative Oncology Group ECOG performance status =\< 1 (Karnofsky \>= 60%)
* Serum creatinine =\< 1.5 x age-adjusted upper limit of normal (ULN) OR calculated creatinine clearance (Cockcroft and Gault) \> 30 mL/min/1.73 m\^2 (within 4 weeks before enrollment)
* Alanine aminotransferase (ALT) =\< 5 x ULN and total bilirubin \< 2.0 mg/dL (or \< 3.0 mg/dL for subjects with Gilbert's syndrome or lymphomatous infiltration of the liver or if taking atazanavir or indinavir (within 4 weeks before enrollment)
* Adequate pulmonary function, defined as =\< Common Terminology Criteria for Adverse Events (CTCAE) grade 1 dyspnea and oxygen saturation (SaO2) \>= 92% on room air (within 4 weeks before enrollment)
* Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) \>= 40% as assessed by echocardiogram or multiple uptake gated acquisition (MUGA) scan performed within 1 month of determination of eligibility
* Absolute neutrophil count: \>= 1,000/mm\^3 (within 4 weeks before enrollment)
* Platelets: \>= 75,000/mm\^3 (within 4 weeks before enrollment)
* Total bilirubin: =\< 1.5 x institutional upper limit of normal (ULN) (3.0 x ULN for patients with Gilbert syndrome) If, however, the elevated bilirubin is felt to be secondary to antiretroviral therapy, the total bilirubin must be =\< 3.5 mg/dL, provided that the direct bilirubin is normal and the aspartate aminotransferase (AST) and ALT =\< 3 x the upper limit of normal (within 4 weeks before enrollment)
* Adequate vascular access for leukapheresis procedure and for administration of the cellular product (either peripheral line or leukapheresis catheter)
* Participants who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy
* The effects of axicabtagene ciloleucel on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry, for the duration of study participation, and 12 months after the last dose of axicabtagene ciloleucel. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
* Men who have partners of childbearing potential must agree to use an effective barrier contraceptive method before study entry, for the duration of study participation, and for 1 year after the last dose of axicabtagene ciloleucel
* Documentation of HIV-1 infection by means of any one of the following:
* Documentation of HIV diagnosis in the medical record by a licensed health care investigator;
* Documentation of receipt of antiretroviral therapy (ART) (at least two different medications that do not constitute a prescription for pre-exposure prophylaxis \[PrEP\]) by a licensed health care investigator. Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name;
* HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating \>1000 RNA copies/mL;
* Any federally approved, licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay. NOTE: A "licensed" assay refers to a U.S. Food and Drug Administration (FDA)-approved assay, which is required for all Investigational New Drug (IND) studies
* HIV viral load below 50 copies/mL by FDA-approved assays within 4 weeks prior to registration
* A CD4 cell count must be obtained within 4 weeks before enrollment at any U.S. laboratory that has a clinical laboratory improvement amendments (CLIA) certification or its equivalent. Twenty participants will be studied with a goal to enroll a minimum of 6 participants with a CD4 \<100 cells/uL
* Participants who have hepatitis C (reactive anti-HCV antibody) and hepatitis B (HBsAg positive and/or anti-HBc-Total positive), may be enrolled, provided total bilirubin is =\< 1.5 x institutional upper limit of normal (ULN), AST (serum glutamic oxaloacetic transaminase \[SGOT\]) and ALT (serum glutamic pyruvic transaminase \[SGPT\]) must be =\< 3 X institutional upper limit of normal, and HBV deoxyribonucleic acid (DNA) \<100 IU/mL (if hepatitis B positive) within 4 weeks before enrollment. There must be no evidence of cirrhosis present
* Participants with hepatitis B core antibody positive must be on an antiviral agent to suppress hepatitis B throughout the study and be willing to continue therapy for at least one year after axicabtagene infusion
* Participants who are willing to continue ART during leukapheresis, manufacturing and infusion and post infusion of axicabtagene ciloleucel
Exclusion Criteria:
* Participants felt to have a high prospect of clinically benefiting from autologous transplantation
* Participants with central nervous system (CNS)-only involvement by malignancy (note: participants with secondary CNS involvement are allowed on study
* Participants with a second prior or concurrent malignancy that, in the opinion of the investigator, has a natural history or treatment course that has the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Treatment with alemtuzumab within 6 months before anticipated leukapheresis, or treatment with fludarabine or cladribine within 3 months before anticipated leukapheresis
* Participants with uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate antibiotics or other treatment at the time of enrollment
* Presence of acute or chronic graft-versus-host disease
* History of any one of the following cardiovascular conditions within the past 6 months: class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
* History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
* Pregnant or nursing women. NOTE: Women of reproductive potential must have a negative serum pregnancy test performed within 48 hours before starting conditioning chemotherapy. Pregnant women are excluded from this study because axicabtagene ciloleucel has not been studied in pregnant women. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with axicabtagene ciloleucel, breastfeeding should be discontinued if the mother is treated with axicabtagene ciloleucel. These potential risks may also apply to other agents used in this study
* Use of the following:
* Therapeutic doses of corticosteroids (defined as \> 20 mg/day prednisone or equivalent) within 7 days before leukapheresis or 72 hours before axicabtagene ciloleucel administration. Physiologic replacement, topical, and inhaled steroids are permitted
* Chemotherapy given after leukapheresis to maintain disease control must be stopped \>= 7 days before conditioning chemotherapy
* Cytotoxic chemotherapeutic agents that are not considered lymphotoxic (see below) within 1 week before leukapheresis. Oral chemotherapeutic agents, including lenalidomide and ibrutinib, are allowed if at least 3 half-lives have elapsed prior to leukapheresis
* Lymphotoxic chemotherapeutic agents (e.g., cyclophosphamide, ifosfamide, bendamustine) within 2 weeks before leukapheresis
* Experimental agents received within 4 weeks before leukapheresis unless no response or disease progression is documented while on the experimental therapy and at least 3 half-lives have elapsed before leukapheresis
* Immunosuppressive therapies within 4 weeks before leukapheresis and axicabtagene ciloleucel administration (e.g., calcineurin inhibitors, methotrexate, or other chemotherapeutics, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti-IL6, or anti-IL6R)
* Donor lymphocyte infusions (DLI) within 6 weeks before axicabtagene ciloleucel administration
* Radiation within 1 week before leukapheresis. Subjects must have progressive disease in irradiated lesions or have additional non-irradiated, PET-positive lesions to be eligible. However, palliative radiation to a single lesion, if additional non-irradiated PET-positive lesions are present, is allowed up to 2 weeks before leukapheresis
* Prior receipt of CAR T-cell therapy
* Participants with signs or symptoms indicative of active CNS involvement are excluded from the protocol, with the following exceptions: The following patients are included in the protocol:
* Participants with previously treated CNS involvement by lymphoma or leukemia, who and have no neurologic symptoms and no evidence of active lymphoma or leukemia in the CNS by total spine and brain gadolinium enhanced magnetic resonance imaging (MRI) within 2 weeks before leukapheresis and no neurologic progression prior to axicabtagene ciloleucel (axi-cel) infusion
* Participants with active CNS involvement and stable neurologic symptoms for at least 3 weeks before leukapheresis and without neurologic progression prior to axi-cel infusion. These patients should have assessment by a total spine and brain gadolinium enhanced MRI within 5 days before axi-cel infusion to document the extent of CNS disease prior to axi-cel infusion. Cerebrospinal fluid (CSF) sampling for cell count, cytology and cell markers by flow cytometry should also be included within 5 days of axi-cel infusion if previously positive
* Inhaled or topical steroids and adrenal replacement doses =\< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, including if \>= 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted. Use of anabolic steroids is permitted
* The participant has not recovered to baseline or CTCAE =\< grade 1 from toxicity due to all prior therapies except =\< grade 2 alopecia, neuropathy, and other non-clinically significant adverse events (AEs), provided that all other eligibility criteria are met
* Opportunistic infection within the last 3 months, with the exception of oropharyngeal candidiasis
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to axicabtagene ciloleucel or other agents used in study
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness with potential to limit compliance with study requirements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：Safety of chimeric antigen receptor (CAR) T-cell therapy · Safety defined as blood count recovery of neutrophils and platelets to grade 2 or less within 6 weeks of CAR-T cell administration; incidence of infections; and cytokine release syndrome as defined by the 2019 American Society for Transplantation and Cellular Therapy harmonized system. The incidence of toxicity will be summarized using frequency and percentage and presented by overall and for each CD4 cohort. · Up to 2 years；Feasibility of CAR-T Therapy · Feasibility defined as ability of enrolled participants in each cohort to receive axicabtagene ciloleucel. Feasibility will be estimated as the proportion of participants who receive axicabtagene ciloleucel among all enrolled participants who undergo leukapheresis. A two-sided 95% exact confidence interval will also be reported together with the estimated proportion. Production failure will be defined as the number of episodes of "inability to collect sufficient T-cells and/or create products." It will be summarized using descriptive statistics. · Up to 2 years
次要终点：Complete response rate；Event-free survival (EFS)；Duration of response (DOR)；CD4 and CD8 counts
患者在第-5、-4和-3天接受30分钟静脉注射氟达拉滨和1小时静脉注射环磷酰胺。随后患者在第0天接受30分钟静脉注射axicabtagene ciloleucel。
这项I期试验评估axicabtagene clioleucel（一种CAR-T疗法）的副作用和有效性，并查明其在治疗复发或难治性HIV相关侵袭性B细胞非霍奇金淋巴瘤患者方面有何效果（如有）。T细胞是能够杀死肿瘤细胞的抗感染血细胞。Axicabtagene ciloleucel由经过基因修饰的T细胞组成，这些T细胞被修饰以识别CD-19，即癌细胞表面的一种蛋白质。这些CD-19特异性T细胞可能帮助人体免疫系统识别并杀死CD-19阳性B细胞非霍奇金淋巴瘤细胞。
This phase I trial evaluates the side effects and usefulness of axicabtagene clioleucel (a CAR-T therapy) and find out what effect, if any, it has on treating patients with HIV-associated aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or not responded to treatment (refractory). T cells are infection fighting blood cells that can kill tumor cells. Axicabtagene ciloleucel consists of genetically modified T cells, modified to recognize CD-19, a protein on the surface of cancer cells. These CD-19-specific T cells may help the body's immune system identify and kill CD-19-positive B-cell non-Hodgkin lymphoma cells.
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