抗 CD22/CD19 CAR-T 细胞疗法 CART2219.1 在成人和儿童复发/难治性 B-ALL 中的 I/II 期试验
A Phase I/II Trial of Anti-CD22/CD19 CAR-T Cell Therapy, CART2219.1, in Adult and Pediatric Relapsed/Refractory B-ALL.
在一项多中心I/II期试验中,所有患者(n=11;7名儿童,4名成人)在第28天均达到完全缓解(91%为微小残留病阴性)。
英文原题:A phase I/II feasibility vaccine study by autologous leukemic apoptotic corpse-pulsed dendritic cells for elderly AML patients.
现在需要更大规模的2期研究,以明确含白血病凋亡小体的DC疫苗在老年及年轻AML人群中的作用。
这是一项I/II期研究,旨在测试自体白血病凋亡小体脉冲树突状细胞(DC)疫苗在首次或第二次完全缓解的老年急性髓系白血病(AML)患者中的可行性。脉冲DC以9 × 10 6皮下(1 mL)和1 × 10 6皮内(0.1 mL)的剂量给药。计划在第+1、+7、+14、+21和+35天接种五剂疫苗。为纳入研究的全部五名患者生产并注射了五剂DC疫苗。未记录到严重不良事件。现在需要更大规模的2期研究,以明确携带白血病凋亡小体的DC疫苗在老年及年轻AML人群中的作用。(Clinicaltrials.gov NCT01146248)。
This was a phase I/II study testing the feasibility of a vaccine by autologous leukemic apoptotic corpse-pulsed dendritic cells (DC) in elderly acute myeloid leukemia (AML) patients in first or second complete remission. Pulsed DC were administered at doses of 9 × 10 6 subcutaneously (1 mL) and 1 × 10 6 intra-dermally (0.1 mL). Five doses of vaccine were planned on days +1 + 7 + 14 + 21 and +35. Five DC-vaccines were produced and injected for all five patients included in the study. No severe adverse event was documented. Larger Phase 2 studies are now required to precise the role of DC-vaccines with leukemic apoptotic bodies in older as well as younger AML populations. (Clinicaltrials.gov NCT01146262).
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