CAR-T治疗复发耐药CD19+淋巴瘤的IIa期临床试验结果

橙色雨丝

来自2015年美国临床肿瘤学会年会的最新报道：

Background: Autologous T cells expressing a chimeric antigen receptor with an external anti-CD19 single chain antibody domain and CD3ζ and 4-1BB signaling domains (CTL019 cells) mediate anti-tumor effects in patients (pts) with relapsed/refractory (r/r) CD19+ leukemias. We are conducting a phase IIa clinical trial of CTL019 cells in r/r CD19+ non-Hodgkin lymphomas.


Methods: Eligible pts have CD19+ follicular lymphoma (FL), diffuse large B cell lymphoma (DLBCL), or mantle cell lymphoma (MCL) with anticipated survival less than 2 years. After collection of peripheral blood leukocytes, pts receive lymphodepleting chemotherapy based on histology and past therapies. One to 4 days after chemotherapy, pts receive 5 x 108CTL019 cells intravenously. Blood and marrow samples are collected for correlative studies. Response assessment is 3 months (mo) after infusion. Enrollment began February 2014; data reported are through January 2015.  

Results: Twenty-nine pts (19 DLBCL; 8 FL; 2 MCL) have enrolled. Median age is 56 (range: 25-77), male:female ratio 17:12, median prior therapies 4 (range: 1-8), and pts with prior ASCT 9 (31%). At enrollment, stages were: IV, 16 pts (55%); III, 5 pts (17%); II, 6 pts (21%); IE, 2 pts (7%); LDH was increased in 20 pts (69%). Eight pts are not evaluable for response (DLBCL 7; FL 1): 3 pts removed from study before T cell infusion due to progressive disease; 1 pt withdrew consent; 3 pts had inadequate T cell expansion; 1 pt received < protocol-specified cell dose. Twenty pts received CTL019 per protocol dose (12 DLBCL; 7 FL; 1 MCL). Pre-infusion chemotherapy regimens were EPOCH (2); cyclophosphamide (9); radiation + cyclophosphamide (2); bendamustine (6); cyclophosphamide-fludarabine (1). Cytokine release syndrome occurred in 15 pts (13 grade 2; 2 grade 3); neurologic toxicity in 3 pts: transient delirium (1 grade 2, 1 grade 3) and 1 possibly related, grade 5 encephalopathy. For 18 pts evaluable for response at 3 mo (12 DLBCL; 6 FL), overall response rate is 67% (DLBCL 50%; FL 100%). At median follow up 6 mo, progression-free survival for evaluable pts is 59% (DLBCL 37%; FL 100%).

Conclusions: CTL019 cells induce durable responses in pts with r/r DLBCL and FL with acceptable toxicity.


试验入组的病人是CD19+的B细胞淋巴瘤患者，预期生存期小于两年。共有29例入组，包括19例弥漫大B，8例滤泡，2例套细胞，中位接受过的治疗次数为4次，31%接受过自体干细胞移植。部分病人因各种原因退组或不能进行评估，18例完成标准治疗的病人中有15例出现细胞因子风暴，在3个月评估时总应答率为67%（弥漫大B50%；滤泡100%），中位随访期6个月时可评估病人的无进展生存率为59%（弥漫大B37%，滤泡100%）。结论：CART细胞对复发耐药弥漫大B和滤泡性淋巴瘤可诱导持续的应答，毒性反应可以接受。

乐山乐水

现在很期待cd19 cart治疗后复发患者再次治疗的消息

乐乐123

真好。滤泡不用担心了

linjiagenga1

希望这个方案资费早日降下来

小草乐乐

国内有这个方案吗？费用大概是多少？

期待康复

健康快乐人 发表于 2015-5-15 18:44
真好。滤泡不用担心了

我记得你的cd19+都被美罗华打没了

期待康复

健康快乐人 发表于 2015-5-15 18:44
真好。滤泡不用担心了

你再看看你检测的t细胞亚群

乐乐123

期待康复 发表于 2015-5-15 21:28
我记得你的cd19+都被美罗华打没了

期待叔，我没什Cd19的免疫组化，当时要求做，但没给做

乐乐123

期待康复 发表于 2015-5-15 21:30
你再看看你检测的t细胞亚群

我看不懂

期待康复

健康快乐人 发表于 2015-5-15 21:32
我看不懂

你有一个t细胞亚群的报告

乐乐123

期待康复 发表于 2015-5-15 21:30
你再看看你检测的t细胞亚群

对哟我现在才看到T细胞亚群的CD19没了，这是不是，我没可用Car—T

期待康复

健康快乐人 发表于 2015-5-15 21:35
对哟我现在才看到T细胞亚群的CD19没了，这是不是，我没可用Car—T

有新靶点，咨询乐山乐水

乐乐123

期待康复 发表于 2015-5-15 21:37
有新靶点，咨询乐山乐水

谢谢期待叔

期待康复

期待康复 发表于 2015-5-15 21:28
我记得你的cd19+都被美罗华打没了

按理美罗华是针对cd20+，可能都打光了，使cd19+也没了

橙色雨丝

乐山乐水 发表于 2015-5-15 18:19
现在很期待cd19 cart治疗后复发患者再次治疗的消息

我也在找相关的消息，不过还没有见到。

橙色雨丝

小草乐乐 发表于 2015-5-15 20:44
国内有这个方案吗？费用大概是多少？

北肿和301在做，论坛上有相关的帖子。