Chimeric antigen receptor-T (CAR-T) therapy remains to be investigated in T-cell malignancies. CD7 is an ideal target for T-cell malignancies but is also expressed on normal T cells, which may cause CAR-T cell fratricide. Donor-derived anti-CD7 CAR-T cells using endoplasmic reticulum retention have shown efficacy in patients with T-cell acute lymphoblastic leukemia (ALL). Here we launched a phase I trial to explore differences between autologous and allogeneic anti-CD7 CAR-T therapies in T-cell ALL and lymphoma. Ten patients were treated and 5 received autologous CAR-T therapies. No dose-limiting toxicity or neurotoxicity was observed. Grade 1–2 cytokine release syndrome occurred in 7 patients, and grade 3 in 1 patient. Grade 1–2 graft-versus-host diseases were observed in 2 patients. Seven patients had bone marrow infiltration, and 100% of them achieved complete remission with negative minimal residual disease within one month. Two-fifths of patients achieved extramedullary or extranodular remission. The median follow-up was 6 (range, 2.7–14) months and bridging transplantation was not administrated. Patients treated with allogeneic CAR-T cells had higher remission rate, less recurrence and more durable CAR-T survival than those receiving autologous products. Allogeneic CAR-T cells appeared to be a better option for patients with T-cell malignancies.
嵌合抗原受体T细胞（CAR-T）疗法在T细胞恶性肿瘤中的疗效仍有待探索。CD7是T细胞恶性肿瘤的理想靶点，但在正常T细胞上也有表达，可能导致CAR-T细胞自相残杀。采用内质网滞留技术的供者来源抗CD7 CAR-T细胞已在T细胞急性淋巴细胞白血病患者中显示疗效。本研究开展了一项I期临床试验，旨在比较自体与异体抗CD7 CAR-T疗法治疗T细胞急淋和淋巴瘤的差异。共入组10例患者，其中5例接受自体CAR-T治疗。未观察到剂量限制性毒性或神经毒性。7例患者出现1-2级细胞因子释放综合征，1例出现3级。2例患者发生1-2级移植物抗宿主病。7例存在骨髓浸润的患者均在一个月内达到完全缓解且微小残留病灶阴性。五分之二的患者实现髓外或结外病灶缓解。中位随访时间为6个月（范围2.7-14个月），期间未进行桥接移植。与接受自体治疗的患者相比，异体CAR-T治疗组缓解率更高、复发更少、CAR-T细胞存活更持久。对于T细胞恶性肿瘤患者，异体CAR-T细胞似乎是更优选择。
Allogenic and autologous anti-CD7 CAR-T cell therapies in relapsed or refractory T-cell malignancies
肿瘤(癌症)患者之家