Delving into the Latest Updates on Multiple antigen specific cell therapy(Hengrui Yuanzheng Bio-Technology Co., Ltd.) with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine, Dendritic cell vaccine

Synonyms

Cytotoxic T-cell therapy, Dendritic cell therapy, MASCT I

+ [6]

Target-

Action

stimulants

Mechanism

Cytotoxic T lymphocytes stimulants, Immunologic cytotoxicity, Immunostimulants

Therapeutic Areas

NeoplasmsNervous System DiseasesSkin and Musculoskeletal Diseases+ [3]

Active Indication

Desmoplastic Small Round Cell TumorEndometrial Stromal SarcomaHemangiosarcoma+ [10]

Inactive Indication

Advanced gastric carcinomaAdvanced Malignant Solid NeoplasmHepatocellular Carcinoma+ [5]

Originator Organization

HRYZ (Shanghai) Biotech Co., Ltd.

Active Organization

HRYZ (Shanghai) Biotech Co., Ltd.

Inactive Organization

The First People's Hospital of Lianyungang

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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主要目的：评估接受标准一线化疗结束后临床获益的尿路上皮癌受试者使用MASCT-I+BSC 维持治疗较单采PBMC 细胞+BSC 对PFS 的改善情况；次要目的：评估MASCT-I+BSC 用于标准一线化疗结束后维持治疗的其他疗效指标，并进一步评估MASCT-I 用于这一人群的安全性。

[Translation]

The primary objective is to evaluate the improvement in PFS of MASCT-I+BSC maintenance therapy compared with single-collected PBMC cells+BSC in subjects with urothelial carcinoma who have achieved clinical benefits after standard first-line chemotherapy. The secondary objective is to evaluate other efficacy indicators of MASCT-I+BSC for maintenance therapy after standard first-line chemotherapy, and further evaluate the safety of MASCT-I in this population.

Start Date09 Jan 2023

Sponsor / Collaborator

Hengruiyuanzheng (Shenzhen) Biotechnology Co., Ltd.

[+1]

CTR20190852

/ CompletedPhase 1

单中心，I期临床研究，评价多抗原自体免疫细胞注射液（MASCT-I）对晚期实体瘤患者的安全性和耐受性

[Translation] A single-center, phase I clinical study evaluating the safety and tolerability of multi-antigen autologous immune cell injection (MASCT-I) in patients with advanced solid tumors

主要目的: MASCT-I对晚期转移或复发且各种标准治疗失败的实体瘤患者的安全性和耐受性。次要目的：MASCT-I给药后的免疫响应。探索性目的: 初步探索MASCT-I的疗效。

[Translation]

Primary objective: To investigate the safety and tolerability of MASCT-I in patients with solid tumors that have advanced metastatic or recurrent disease and have failed various standard treatments. Secondary objective: To investigate the immune response after administration of MASCT-I. Exploratory objective: To preliminarily explore the efficacy of MASCT-I.

Start Date21 Apr 2020

Sponsor / Collaborator

Hengruiyuanzheng (Shenzhen) Biotechnology Co., Ltd.

[+1]

100 Clinical Results associated with Multiple antigen specific cell therapy(Hengrui Yuanzheng Bio-Technology Co., Ltd.)

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100 Translational Medicine associated with Multiple antigen specific cell therapy(Hengrui Yuanzheng Bio-Technology Co., Ltd.)

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100 Patents (Medical) associated with Multiple antigen specific cell therapy(Hengrui Yuanzheng Bio-Technology Co., Ltd.)

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3

Literatures (Medical) associated with Multiple antigen specific cell therapy(Hengrui Yuanzheng Bio-Technology Co., Ltd.)

01 Sep 2019·Cancer Immunology, ImmunotherapyQ2 · MEDICINE

Safety and efficacy of PD-1 blockade-activated multiple antigen-specific cellular therapy alone or in combination with apatinib in patients with advanced solid tumors: a pooled analysis of two prospective trials

Q2 · MEDICINE

Article

Author: Wen, Yixuan ; Geng, Xiaowei ; Hui, Kaiyuan ; Xia, Youyou ; Wang, Lei ; Hu, Chenxi ; Chen, Ting ; Qiao, Yun ; Jiang, Xiaodong ; Liang, Lijun ; Fei, Jiayan ; Hu, Rong

BACKGROUNDThe lethal effects of multiple antigen-specific cellular therapy (MASCT) may be enhanced by blocking PD-1 in vitro and vascular endothelial growth factor receptor 2 inhibitor (apatinib). We analyzed the pooled data from our phase I/II trials to determine the toxicity and efficacy of PD-1 blockade (SHR-1210)-activated MASCT (aMASCT) alone or in combination with apatinib in advanced solid tumors.METHODSPatients with advanced solid tumors received aMASCT alone (n = 32) or aMASCT plus apatinib (500 mg q.d., n = 38) after standard treatment. The safety profile was the primary end point. The secondary end points were antitumor response, progression-free survival (PFS), and overall survival (OS). The circulating T cells were quantified before and after aMASCT infusion.RESULTSTreatment-related adverse events (AEs) occurred in 18/32 (56.3%) and 25/38 (65.8%) patients in the aMASCT and aMASCT plus apatinib groups, respectively. No serious AEs were reported, and apatinib did not increase immunotherapy-related toxicity. The objective response rate (34.2% and 18.8%) and PFS (median 6.0 and 4.5 months, P = 0.002) were improved in the aMASCT plus apatinib group compared with the aMASCT group; however, the OS was not improved (median 10.0 and 8.2 months, P = 0.098). Multivariate analyses indicated that two or more cycles of aMASCT treatment was an independent and favorable prognostic factor of PFS and OS. The circulating T cells increased and Tregs decreased in both groups after one cycle of aMASCT treatment.CONCLUSIONSTreatment with aMASCT plus apatinib was safe and effective for the management of advanced solid tumors.

01 Jan 2018·Journal of CancerQ3 · MEDICINE

Multiple Antigen Stimulating Cellular Therapy (MASCT) For Hepatocellular Carcinoma After Curative Treatment: A Retrospective Study

Q3 · MEDICINE

ArticleOA

Author: Hu, Xiaoyun ; Hou, Jinlin ; Liu, Li ; He, Yajing ; Li, Xiaoshuang ; Zhang, Xiaoyong ; Kong, Yanjun ; Zhou, Xiangjun ; Guo, Yabing ; Chen, Jinzhang

Background & Aims: The prognosis of hepatocellular carcinoma (HCC) remains poor and available treatment options are limited. This retrospective study evaluated the efficacy of Multiple Antigen Stimulating Cell Therapy (MASCT) as an adjuvant therapy for the treatment of HCC after curative treatment. Methods: Patients who underwent HCC curative treatments were classified into two groups: the MASCT group, in which patients received MASCT treatment after curative treatment (n = 47), and the control group, in which patients did not receive any treatment after curative treatment (n = 99). Patients who received ≥ 5 courses of MASCT treatment before recurrence or death (n = 26) were further stratified into a subgroup (multiple-course MASCT group) for analysis. The primary endpoint was overall survival (OS). The secondary endpoints were disease-free survival (DFS) and safety. Results: Kaplan-Meier analysis showed no statistically significant difference in OS between the MASCT group and the control group (P = 0.132), nor in DFS (P = 0.310) (median: 36.17 vs. 24.27 months). However, when comparing the multiple-course MASCT treated group to the control group, Kaplan-Meier analysis showed a significant difference in OS (P = 0.011), but not in DFS (P = 0.104) (median: 47.10 vs. 24.27 months). The overall incidences of treatment-related adverse events in the MASCT group and control group were 14.89% (7/47) and 19.19% (19/99), respectively. No MASCT treatment-related serious adverse events were reported. Conclusions: Although the MASCT group was not associated with significantly longer OS or DFS, the multiple-course MASCT group showed significantly improved overall survival after curative treatment, and the treatment procedures were well-tolerated. Multiple-course MASCT may therefore provide another choice for patients with HCC after curative treatment.

BMC Medicine

A pilot study of multi-antigen stimulated cell therapy-I plus camrelizumab and apatinib in patients with advanced bone and soft-tissue sarcomas

Article

Author: Wang, Yaling ; Tang, Lina ; Hu, Haiyan ; Zheng, Shuier ; Yao, Yang ; Qian, Guowei ; Yang, Qingcheng ; Zhang, Bing ; Yu, Wenxi ; Zhou, Chenliang ; Huang, Yujing ; He, Aina ; Li, Xiaoshuang ; Li, Hongtao ; Yang, Cheng ; Zhou, Yan ; Li, Mei ; Wang, Yonggang ; Shen, Zan ; Zhang, Jianjun

AbstractBackgroundCell-based immunotherapy shows the therapeutic potential in sarcomas, in addition to angiogenesis-targeted tyrosine kinase inhibitor (TKI) and immune checkpoint inhibitor (ICI). Multi-antigen stimulated cell therapy-I (MASCT-I) technology is a sequential immune cell therapy for cancer, which composes of multiple antigen-loaded dendritic cell (DC) vaccines followed by the adoptive transfer of anti-tumor effector T-cells.MethodsIn this phase 1 study, we assessed MASCT-I plus camrelizumab (an ICI against PD-1) and apatinib (a highly selective TKI targeting VEGFR2) in patients with unresectable recurrent or metastatic bone and soft-tissue sarcoma after at least one line of prior systemic therapy. One MASCT-I course consisted of 3 DC subcutaneous injections, followed by 3 active T cell infusions administered 18–27 days after each DC injection. In schedule-I group, 3 DC injections were administered with a 28-day interval in all courses; in schedule-II group, 3 DC injections were administered with a 7-day interval in the first course and with a 28-day interval thereafter. All patients received intravenous camrelizumab 200 mg every 3 weeks and oral apatinib 250 mg daily.ResultsFrom October 30, 2019, to August 12, 2021, 19 patients were enrolled and randomly assigned to schedule-I group (n = 9) and schedule-II group (n = 10). Of the 19 patients, 11 (57.9%) experienced grade 3 or 4 treatment-related adverse events. No treatment-related deaths occurred. Patients in schedule-II group showed similar objective response rate (ORR) with those in schedule-I group (30.0% versus 33.3%) but had higher disease control rate (DCR; 90.0% versus 44.4%) and longer median progression-free survival (PFS; 7.7 versus 4.0 months). For the 13 patients with soft-tissue sarcomas, the ORR was 30.8%, DCR was 76.9%, and median PFS was 12.9 months; for the 6 patients with osteosarcomas, the ORR was 33.3%, the DCR was 50.0%, and median PFS was 5.7 months.ConclusionsOverall, MASCT-I plus camrelizumab and apatinib was safe and showed encouraging efficacy in advanced bone and soft-tissue sarcoma, and schedule-II administration method was recommended.Trial registrationClinicalTrials.gov, NCT04074564.

100 Deals associated with Multiple antigen specific cell therapy(Hengrui Yuanzheng Bio-Technology Co., Ltd.)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Desmoplastic Small Round Cell Tumor	Phase 2	China	HRYZ (Shanghai) Biotech Co., Ltd.	01 Feb 2024
Hemangiosarcoma	Phase 2	China	HRYZ (Shanghai) Biotech Co., Ltd.	01 Feb 2024
Locally Advanced Soft Tissue Sarcoma	Phase 2	China	HRYZ (Shanghai) Biotech Co., Ltd.	01 Feb 2024
Advanced Urothelial Carcinoma	Phase 2	China	HRYZ (Shanghai) Biotech Co., Ltd.	09 Jan 2023
metastatic non-small cell lung cancer	Phase 1	China	The First People's Hospital of Lianyungang	01 Aug 2017
metastatic non-small cell lung cancer	Phase 1	China	HRYZ (Shanghai) Biotech Co., Ltd.	01 Aug 2017
Hepatocellular Carcinoma	Phase 1	-	HRYZ (Shanghai) Biotech Co., Ltd.	01 Aug 2016
Relapsed Solid Neoplasm	Phase 1	-	HRYZ (Shanghai) Biotech Co., Ltd.	01 Aug 2016
Advanced Malignant Solid Neoplasm	Phase 1	China	HRYZ (Shanghai) Biotech Co., Ltd.	01 Jul 2016
T-Cell Lymphoma	Phase 1	China	HRYZ (Shanghai) Biotech Co., Ltd.	01 Jul 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03034304 (MASCT-I-1001, ASCO2023) Manual	Phase 1	Metastatic urothelial carcinoma	39	platinum based-chemotherapy+MASCT-I+camrelizumab	(ytkznhrlok) = gnjcsrknml ehvgnfyxzq (qhkeugdqsy ) View more	Positive	26 May 2023
NCT02844881 (Pubmed \| Cancer Immunol Immunother) Manual	Phase 1/2	Solid tumor	70	MASCT	(mbdgfmbiuu) = zazzalonpw fvrjfvjfxm (tcsnwdcxga ) View more	Positive	01 Sep 2019
NCT02844881 (Pubmed \| Cancer Immunol Immunother) Manual	Phase 1/2	Solid tumor	70	apatinib+MASCT	(mbdgfmbiuu) = ooewoehtxi fvrjfvjfxm (tcsnwdcxga ) View more	Positive	01 Sep 2019