PA3-17 Injection for the Treatment of Subjects With Relapsed/Refractory T-Lymphoblastic Leukemia/Lymphoma: A Single-Arm, Open-Label Phase II Clinical Trial

**Translation:**
This clinical trial is designed as a single-arm, open-label, multicenter study. After signing the informed consent form, eligible subjects will undergo a single nucleated cell collection for the preparation of CAR-T cells. Following lymphodepletion pretreatment, a single infusion of PA3-17 injection will be administered. Blood samples will be collected from the subjects before and after the infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety evaluations. In addition to the baseline period, the treatment phase will involve efficacy assessments at 4 weeks, 2 months, 3 months, and every 3 months thereafter, up to 24 months post-cell infusion. Tumor assessments will continue until disease progression (PD), initiation of new antitumor treatment, death, unacceptable toxicity, investigator decision, or subject's voluntary withdrawal, whichever occurs first.

开始日期2025-10-01

申办/合作机构

博生吉医药科技（苏州）有限公司

NCT06871644

/ Not yet recruitingN/A

CD7CAR-T Cell Therapy As a Single-Arm, Open-Label, Single-Center Investigator-Initiated Early-Stage Clinical Study

The primary objective was to evaluate the safety of CD7 CAR-T cells for the treatment of subjects with relapsed/refractory AID. CD7 CAR-T cells were infused in a single infusion in subjects who were screened after signing an informed consent form and undergoing single nucleus cell collection and pretreatment, and blood was collected before and after the infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety evaluations.

开始日期2025-03-18

申办/合作机构

博生吉医药科技（苏州）有限公司

ChiCTR2200055775

/ Recruiting临床1期IIT

A phase I open-label, dose-escalation trial of PA3-17 injection in adult patients with CD7-positive relapsed/refractory lymphoid hematologic malignancies

开始日期2021-12-01

申办/合作机构

郑州大学第一附属医院

[+1]

100 项与 PA3-17 相关的临床结果

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100 项与 PA3-17 相关的转化医学

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100 项与 PA3-17 相关的专利（医药）

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项与 PA3-17 相关的文献（医药）

2022-07-01·CLINICAL CANCER RESEARCH1区 · 医学

Autologous Nanobody-Derived Fratricide-Resistant CD7-CAR T-cell Therapy for Patients with Relapsed and Refractory T-cell Acute Lymphoblastic Leukemia/Lymphoma

1区 · 医学

Article

作者: Chen, Dan ; Xiang, Shufen ; Nan, Feifei ; Zhang, Lei ; Li, Xin ; Wang, Xinhua ; Li, Ling ; Chang, Yu ; Yan, Jiaqin ; Wang, Yu ; Zhang, Mingzhi ; Meng, Huimin ; Wu, Xiaolong ; Yang, Lin ; Zhang, Bozhen ; Zhou, Zhiyuan ; Wang, Yinyan ; Li, Zhaoming ; Pan, Guifang ; Li, Jiwei ; Chen, YuSheng ; Wang, Min ; Yu, Hui ; Xu, Hanying ; Fu, Xiaorui ; Sun, Zhenchang ; You, Fengtao

Abstract:

Purpose::

Since CD7 may represent a potent target for T-lymphoblastic leukemia/lymphoma (T-ALL/LBL) immunotherapy, this study aimed to investigate safety and efficacy of autologous CD7–chimeric antigen receptor (CAR) T cells in patients with relapsed and refractory (R/R) T-ALL/LBL, as well as its manufacturing feasibility.

Patients and Methods::

Preclinical phase was conducted in NPG mice injected with Luc+ GFP+CCRF-CEM cells. Open-label phase I clinical trial (NCT04004637) enrolled patients with R/R CD7-positive T-ALL/LBL who received autologous CD7-CAR T-cell infusion. Primary endpoint was safety; secondary endpoints included efficacy and pharmacokinetic and pharmacodynamic parameters.

Results::

CD7 blockade strategy was developed using tandem CD7 nanobody VHH6 coupled with an endoplasmic reticulum/Golgi-retention motif peptide to intracellularly fasten CD7 molecules. In preclinical phase CD7 blockade CAR T cells prevented fratricide and exerted potent cytolytic activity, significantly relieving leukemia progression and prolonged the median survival of mice. In clinical phase, the complete remission (CR) rate was 87.5% (7/8) 3 months after CAR T-cell infusion; 1 patient with leukemia achieved minimal residual disease–negative CR and 1 patient with lymphoma achieved CR for more than 12 months. Majority of patients (87.5%) only had grade 1 or 2 cytokine release syndrome with no T-cell hypoplasia or any neurologic toxicities observed. The median maximum concentration of CAR T cells was 857.2 cells/μL at approximately 12 days and remained detectable up to 270 days.

Conclusions::

Autologous nanobody-derived fratricide-resistant CD7-CAR T cells demonstrated a promising and durable antitumor response in R/R T-ALL/LBL with tolerable toxicity, warranting further studies in highly aggressive CD7-positive malignancies.

2002-11-01·Molecular therapy : the journal of the American Society of Gene Therapy1区 · 医学

pa317 Retrovirus Packaging Cells

1区 · 医学

Article

作者: A.Dusty Miller

History of the retroviral vectors technol., focusing on the production of PA317 cells, is presented.PA317 cells and vectors produced from these cells have been the most thoroughly tested of any retroviral vector system in human clin. trials, and have exhibited an outstanding safety record.

2001-07-01·[Zhonghua yan ke za zhi] Chinese journal of ophthalmology

[Preparation of green fluorescent protein retrovirus and its application in mediating gene transfer into retinal pigment epithelial cells].

Article

作者: Tian, S ; Chen, X ; Wang, F ; Liu, W ; Li, C ; Xig, K ; Fan, Y ; Huang, Q ; Gu, Q ; Xu, P

OBJECTIVE:

To determine whether human retinal pigment epithelial (RPE) cells can be infected by retrovirus and modified by retrovirus-mediated gene transfer.

METHODS:

Recombination retroviral vector pLNCX-GFP (green fluorescent protein, GFP) was generated by inserting 780 bp GFP cDNA fragment into the MCS site of pLNCX. pLNCX-GFP was transfected into ecotropic packaging cell line PhiX-Eco and amphotropic packaging cell line PhiX-Ampho and PA317. Retroviral titer was tested by counting GFP expression of NIH3T3 cells. Then RPE cells were infected by using GFP retrovirus-containing supernatant.

RESULTS:

GFP was expressed and retrovirus was produced upon pLNCX-GFP being transfected into packaging cell line. The GFP retrovirus was able to infect primary cultured human RPE cells and immortalized RPE cell line.

CONCLUSION:

The retrovirus can introduce a foreign gene into RPE cells efficiently, thereby it can be used as an important tool to deliver gene into RPE for therapy of fundus diseases.

项与 PA3-17 相关的新闻（医药）

2025-10-10

·细胞基因治疗前沿

国产首款自体CD7-CAR-T细胞药物II期关键临床正式启动

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。 2025年10月7日，博生吉医药与安科生物联合主办、默天旎协办的“全球首款自体CD7-CAR-T细胞（PA3-17注射液）II期关键临床全国多中心启动会” 隆重召开。 PA3-17注射液是博生吉医药完全自主研发的全球首款进入II期关键临床的自体CD7-CAR-T细胞治疗产品，PA3-17为靶向CD7自体CAR-T细胞疗法，其纳米抗体技术增强CAR-T细胞对肿瘤的杀伤力与渗透力，能更精准、有效地攻击肿瘤细胞。同时其PEBL阻断技术采用非基因编辑方式，巧妙防止CAR-T细胞自相残杀，显著提升治疗的安全性，为患者带来更可靠的治疗保障。该产品凭借两大核心技术突破：创新非基因编辑策略：成功解决CAR-T细胞自相残杀及肿瘤细胞污染的行业共性难题；全新质控体系：保障细胞产品高质量、高稳定性制备。今年5月公司公布了13例经多线治疗失败的晚期R/R T-ALL/LBL患者结果：客观缓解率（ORR）：84.6%（11/13），其中76.9%完全缓解（CR）。长期缓解：在3m完全缓解的患者中，50%持续缓解超过15个月，且均未进行干细胞移植。安全性可控：治疗过程中未发生3级及以上的ICANS；3级及以上CRS发生率仅为23.1%，无4级CRS。 PA3-17注射液II期关键临床试验的启动，不仅是一个研究阶段的进阶，更是中国原创细胞治疗药物走向全球市场的关键一步。博生吉医药与安科生物的这一重大进展，标志着我国在CAR-T研发领域已从“跟跑”转向“并跑”甚至“领跑”。期待，不久的未来，这款具备全球竞争力的“中国造”细胞药物能够早日上市，为无数T细胞恶性肿瘤患者带来新曙光。文章来源：公司公告扫码进群掌握CAR-T疗法、干细胞疗法、基因疗法、溶瘤病毒、核酸药物全方位信息

细胞疗法基因疗法免疫疗法临床1期临床2期

2025-10-10

·同写意

国产首款自体CD7-CAR-T细胞药物PA3-17注射液II期关键临床正式启动

临床1期免疫疗法细胞疗法CSCO会议临床2期

2025-09-18

·细胞基因治疗前沿

安科生物：参股公司CD7 CAR-T开展关键性Ⅱ期临床

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。 9月17日，安科生物(300009.SZ)公告称，公司参股公司博生吉医药科技（苏州）有限公司、博生吉安科细胞技术有限公司收到国家药品监督管理局药品审评中心签发的PA3-17注射液II期沟通交流会议纪要，同意申请人开展PA3-17注射液关键性II期临床试验。 PA3-17注射液是博生吉安科自主研发的全球首款获得新药临床试验批准的靶向CD7的自体CAR-T细胞治疗产品，用于治疗成人复发、难治性CD7阳性血液淋巴系统恶性肿瘤。该产品利用先进的基因工程技术改造患者自身的T细胞，使其能够特异性识别并杀伤表达CD7阳性的肿瘤细胞。该品已完成针对成人复发/难治性T淋巴母细胞白血病/淋巴瘤（R/R T-ALL/LBL）患者的I期注册临床试验，展现了显著的缓解率和可控的安全性，最佳客观缓解率（ORR）高达84.6%，并被CDE纳入突破性治疗品种名单。本次沟通交流会议与CDE达成共识后，博生吉安科将开展针对成人复发/难治性T淋巴母细胞白血病/淋巴瘤（R/R T-ALL/LBL）患者的关键性II期临床试验。安科生物集团董事长宋礼华博士指出：“PA3-17注射液的突破性进展，为全球T细胞肿瘤CAR-T疗法的研发树立了标杆，证实了该治疗路径的可行性，将极大地鼓舞和推动整个行业在该领域的发展。安科生物非常高兴能够在这一过程中为博生吉医药和博生吉安科的发展提供支持。” 博生吉创始人兼董事长杨林博士表示： “本项目进入关键临床试验II期，意味着PA3-17注射液的科学价值、临床潜力以及公司开发策略获得了多方肯定。这背后，凝聚着博生吉团队在艰难技术领域持续探索、攻坚克难的不懈努力，更离不开黄晓军院士、张明智教授、梅恒教授、邹德慧教授等临床PI团队的卓越贡献和坚定支持。我们备受鼓舞，将以患者需求为核心，加速推进Ⅱ期临床试验，同步完善商业化生产布局，全力推动这一源自中国的创新细胞治疗产品早日上市，不仅惠及中国患者，更为解决全球T细胞肿瘤患者的治疗难题贡献中国智慧与方案。” 文章来源：博生吉扫码进群掌握CAR-T疗法、干细胞疗法、基因疗法、溶瘤病毒、核酸药物全方位信息

细胞疗法临床1期免疫疗法临床2期基因疗法

100 项与 PA3-17 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
T细胞急性淋巴细胞白血病/淋巴瘤	临床2期	中国	博生吉安科细胞技术有限公司	2025-10-11
CD7阳性T细胞白血病	临床2期	-	博生吉医药科技（苏州）有限公司	2025-10-01
T细胞淋巴瘤	临床2期	中国	博生吉医药科技（苏州）有限公司	2021-08-05
混合表型急性白血病	临床2期	中国	博生吉医药科技（苏州）有限公司	2021-06-01
CD7阳性肿瘤	临床1期	中国	博生吉医药科技（苏州）有限公司	2022-02-21
ALK阳性间变性大细胞淋巴瘤	临床1期	中国	博生吉医药科技（苏州）有限公司	2020-11-24
间变性大细胞淋巴瘤	临床1期	中国	博生吉医药科技（苏州）有限公司	2020-11-24
CD7阳性血液肿瘤	临床1期	中国	博生吉医药科技（苏州）有限公司	2020-11-24
肠病相关的T细胞淋巴瘤	临床1期	中国	博生吉医药科技（苏州）有限公司	2020-11-24
免疫母细胞性淋巴结病	临床1期	中国	博生吉医药科技（苏州）有限公司	2020-11-24

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临床结果

适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05170568 (PS1369, EHA2025)	临床1期	T细胞急性淋巴细胞白血病/淋巴瘤 CD7	13	PA3-17 Injection	蓋構淵憲鏇夢餘淵壓遞(襯鬱蓋簾襯餘選鏇觸憲) = Cytokine release syndrome (CRS) incidence was 84.6% (G3:23.1%, no G4) 窪廠繭廠選壓鹹築淵餘 (顧積齋簾鏇壓積膚膚艱 ) 更多	积极	2025-05-14
NCT05170568 (ASCO2024) 人工标引	临床1期	前体T淋巴细胞白血病淋巴瘤 \| 淋巴瘤 CD7	12	PA3-17 Injection 0.5×10^6 CAR-T/kg	願醖願觸廠襯襯蓋廠選(範鑰積觸範餘鹽淵淵壓) = None 廠網觸觸艱簾糧觸餘選 (襯窪鹽觸繭齋範遞顧獵 ) 更多	积极	2024-05-24
NCT05170568 (ASH2023)	临床1期	难治性T淋巴细胞淋巴瘤	9	DL: 0.5×10^6 CAR-T/kg	觸衊觸廠鹽夢顧壓窪壓(夢鑰獵鏇遞鏇簾觸鏇遞) = 憲鹹範糧鑰顧淵廠窪鏇網壓製鹹醖鑰鹽鏇築積 (憲鑰壓餘鑰鬱廠鹽鬱構 )	-	2023-12-10
NCT04004637 (PA3-17, CSCO2022)	临床1期	T细胞急性淋巴细胞白血病/淋巴瘤	11	PA3-17 注射液	窪獵觸鹽夢繭鹽積淵鹹(齋衊壓艱簾憲廠廠蓋積) = 患者均出现了CRS(1-2级, n=10；4级, n=1) 鑰夢淵膚獵製襯廠衊獵 (蓋構醖淵簾遞糧鹽觸鹹 ) 更多	-	2022-09-21
NCT04004637 (Pubmed \| Clin Cancer Res) 人工标引	临床1期	T细胞急性淋巴细胞白血病/淋巴瘤 CD7 Positive	8	PA3-17	廠製築構網繭鹽繭築遞(構淵網齋顧衊遞築獵遞) = 構製鑰遞衊夢鏇製壓顧鹽糧鹽顧廠淵簾膚獵鏇 (繭壓遞淵夢觸鬱餘夢齋 ) 更多	积极	2022-07-01