肿瘤细胞治疗研究
英文原题：CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma
CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma
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这是一项 I 期注册临床试验，评估自体细胞治疗用于急性淋巴细胞白血病、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 10 例。试验地点：欧洲 · 布拉格（共 1 个中心）。登记号：NCT05054257。
不限性别 · ≥ 18 Years 且 ≤ 80 Years
纳入标准： 1. CD19阳性B-ALL或B-NHL患者，且符合以下任一条件： 1. B-ALL难治或第二次及以上复发（血液学或分子学复发）； 2. B-NHL难治，或首次复发但不适合自体干细胞移植（ASCT），或第二至第四次复发； 3. B-ALL或B-NHL在自体或异基因造血细胞移植（HCT）后复发； 2. 流式细胞术或免疫组化证实恶性细胞表达CD19； 3. 年龄≥18岁且≤80岁； 4. 患者能够理解并签署知情同意书； 5. 有生育能力的女性：入组访视（PSV）及访视1时妊娠检测均须阴性。 一般排除标准： 1. 已知对研究药品（IMP）任何成分过敏； 2. IMP给药前3个月内接受过自体或异基因HCT； 3. 严重且未控制的活动性感染； 4. 预期生存期<6周； 5. 脑实质中枢神经系统受累； 6. 呼吸功能不全（需要氧疗）； 7. 严重肝功能损害：胆红素>50 μmol/L，或AST/ALT>正常值上限4倍； 8. 急性肾损伤，血清肌酐>180 μmol/L、少尿或需要急性透析； 9. 超声心动图显示心力衰竭且射血分数（EF）<30%； 10. 活动性3–4级急性GVHD； 11. 严重且未控制的神经系统合并症； 12. IMP给药前4周内或给药后90天内接种活病毒疫苗； 13. 女性妊娠或哺乳； 14. 有生育能力者不愿在研究期间采取高效避孕措施；永久禁欲为其生活方式选择者除外。女性患者或男性患者有生育能力的女性伴侣不愿采取高效避孕措施者排除。 IMP制备起始材料采集排除标准： 1. 严重且未控制的活动性感染； 2. HIV-1/2、乙肝/丙肝或梅毒检测阳性； 3. 白细胞单采前近期/同时接受下列治疗：自体或异基因HCT在12周内；克拉屈滨、氟达拉滨或阿仑单抗在8周内；供者淋巴细胞输注在4周内；聚乙二醇化天冬酰胺酶在4周内；维持化疗在2周内；长效G-CSF在2周内；长春新碱在2周内；鞘内甲氨蝶呤在1周内；G-CSF在5天内；治疗剂量皮质类固醇在3天内；短效细胞抑制剂在3天内。 IMP给药排除标准： 1. 严重且未控制的活动性感染； 2. 预期生存期<6周； 3. 脑实质中枢神经系统受累； 4. 呼吸功能不全（需要氧疗）； 5. 严重肝功能损害：胆红素>50 μmol/L或AST/ALT>正常值上限4倍； 6. 急性肾损伤，血清肌酐>180 μg/L、少尿或需要急性透析； 7. 超声心动图显示心力衰竭且EF<30%； 8. 活动性3–4级急性GVHD； 9. 严重且未控制的神经系统合并症。
Inclusion Criteria:
1. Patient with refractory or relapsing CD19 positive B-ALL or B-NHL defined as:
1. B-ALL refractory to treatment or in the second or subsequent relapse (hematological OR molecular), OR
2. B-NHL refractory to treatment or in first relapse ineligible for autologous stem cell transplantation (ASCT) or in second to fourth relapse, OR
3. B-ALL or B-NHL relapsing after autologous or allogeneic hematopoietic cell transplantation (HCT).
2. CD19 expression on malignant cells confirmed by flow cytometry or by immunohistochemistry.
3. Age ≥18 years and ≤ 80 yearss.
4. Patient able to understand and sign informed consent.
5. Women of child-bearing potential: negative pregnancy test at enrolment (PSV) and at Visit 1.
General Exclusion Criteria:
1. Known hypersensitivity to any component of the Investigational Medicinal Product (IMP).
2. Autologous or allogeneic HCT in 3 months prior to IMP administration.
3. Severe, uncontrolled active infection.
4. Life expectancy \< 6 weeks.
5. Parenchymal central nervous system involvement.
6. Respiratory insufficiency (need for oxygen therapy).
7. Significant liver impairment: bilirubin \> 50 µmol/L, AST or ALT \> 4times normal upper limit.
8. Acute kidney injury with serum creatinine \> 180 µmol/L, oliguria or need for acute dialysis.
9. Heart failure with EF \< 30% by echocardiography.
10. Presence of active grade 3-4 acute GvHD.
11. Serious uncontrolled neurological comorbidity.
12. Vaccination with live virus vaccines in the 4 weeks before IMP administration and within 90 days after the IMP dose.
13. Women: pregnancy or breast-feeding.
14. Subjects of fertile age, unless permanent sexual abstinence is their lifestyle choice:
* female patients of childbearing potential not willing to use a highly effective method of contraception during the study,
* male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a highly effective method of contraception during the study.
Exclusion criteria to Procurement of IMP manufacture starting material
1. Severe uncontrolled active infection.
2. Positive test results for HIV1/2, Hepatitis B/C and lues.
3. Concurrent or recent prior therapies before apheresis:
* Autologous or allogeneic hematopoietic cell transplantation within 12 weeks.
* Clofarabine, Fludarabine, Alemtuzumab within 8 weeks.
* Donor lymphocyte infusions within 4 weeks.
* Pegylated asparaginase within 4 weeks.
* Maintenance chemotherapy within 2 weeks.
* Long-acting Granulocyte Colony Stimulating Factor (G-CSF) within 2 weeks.
* Vincristine within 2 weeks.
* Intrathecal methotrexate within 1 week.
* Granulocyte Colony Stimulating Factor (G-CSF) within 5 days.
* Therapeutic dose of corticosteroids within 3 days.
* Short-acting cytostatics within 3 days
Exclusion criteria to IMP administration
1. Severe, uncontrolled active infections.
2. Life expectancy \< 6 weeks.
3. Parenchymal central nervous system involvement
4. Respiratory insufficiency (need for oxygen therapy).
5. Significant liver impairment: bilirubin \> 50 µmol/L, Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \> 4times normal upper limit.
6. Acute kidney injury with serum creatinine \> 180 µg/L, oliguria or need for acute dialysis.
7. Heart failure with Ejection Fraction (EF) \< 30% by echocardiography.
8. Presence of active grade 3 - 4 acute GvHD
9. Serious uncontrolled neurological comorbidity.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：Incidence of adverse events · Cumulative incidence of IMP-related adverse events (AEs) graded by ASTCT consensus grading criteria for Cytokine Release Syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS) and by Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 for other AEs. Toxicities will be followed from the start of Blood Collection or Apheresis until the end of the study. · Up to 2 years post treatment；Assessment of Dose-Limiting Toxicities (DLTs) · Incidence of Dose-limiting toxicities (DLTs) during the first 28 days after IMP administration · Up to 28 days after IMP administration
次要终点：Complete remission ( CR) rate；Overall Survival；Quality of life using the European Organization for the Research and Treatment of Cancer 30 item questionnaire (EORTC QLQ-C30).
表达CD19特异性嵌合抗原受体的人自体T淋巴细胞。
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一项I期剂量递增研究，评估CAR-T19细胞治疗成人复发/难治性急性淋巴细胞白血病和非霍奇金淋巴瘤。
Phase I Dose Escalation Study of CART19 Cells for Adult Patients With Relapsed / Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma.
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