[Translation] A multicenter, open-label, dose-escalation, single/multiple-dose clinical trial to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of recombinant human calcineurin B for injection in the treatment of Chinese patients with advanced liver cancer and gastric cancer

主要目的： ①本研究选择中国晚期肝癌、胃癌患者为试验对象，考察中国晚期肝癌、胃癌患者单药给予注射用重组人钙调蛋白磷酸酶B的安全性、耐受性，确定最大耐受剂量（MTD）； ②评价注射用重组人钙调蛋白磷酸酶B单/多次给药在中国晚期肝癌、胃癌患者体内的药代动力学（pharmacokinetics，PK）特征。次要目的： ①评价注射用重组人钙调蛋白磷酸酶B在中国晚期肝癌、胃癌患者的单/多次给药后免疫原性特征； ②初步评价注射用重组人钙调蛋白磷酸酶B在中国晚期肝癌、胃癌患者的药效动力学（pharmacodynamics，PD）指标。探索性目的： ①初步探索注射用重组人钙调蛋白磷酸酶B治疗晚期肝癌、胃癌患者的临床有效性及有效剂量范围； ②初步探索注射用重组人钙调蛋白磷酸酶B疗效的生物标志物。

[Translation]

Main objectives: ①This study selected Chinese patients with advanced liver cancer and gastric cancer as test subjects to investigate the safety and tolerability of single-drug recombinant human calcineurin B for injection in Chinese patients with advanced liver cancer and gastric cancer, and determine the maximum tolerated dose (MTD); ②Evaluate the pharmacokinetic (PK) characteristics of single/multiple administration of recombinant human calcineurin B for injection in Chinese patients with advanced liver cancer and gastric cancer. Secondary objectives: ①Evaluate the immunogenicity characteristics of recombinant human calcineurin B for injection after single/multiple administration in Chinese patients with advanced liver cancer and gastric cancer; ②Preliminary evaluation of the pharmacodynamics (PD) indicators of recombinant human calcineurin B for injection in Chinese patients with advanced liver cancer and gastric cancer. Exploratory objectives: ①Preliminary exploration of the clinical efficacy and effective dose range of recombinant human calcineurin B for injection in the treatment of patients with advanced liver cancer and gastric cancer; ②Preliminary exploration of biomarkers of the efficacy of recombinant human calcineurin B for injection.

Start Date02 Mar 2021

Sponsor / Collaborator

Beijing Normal University

[+1]

100 Clinical Results associated with Recombinant human Calcineurin B subunit(Haikou Qili Pharmaceutical)

100 Translational Medicine associated with Recombinant human Calcineurin B subunit(Haikou Qili Pharmaceutical)

100 Patents (Medical) associated with Recombinant human Calcineurin B subunit(Haikou Qili Pharmaceutical)

Literatures (Medical) associated with Recombinant human Calcineurin B subunit(Haikou Qili Pharmaceutical)

01 Jan 2023·PloS one

An oral cholera vaccine in the prevention and/or treatment of inflammatory bowel disease.

Article

Author: Schwamborn, Klaus ; Hanson, Melissa ; Rousseaux, Christel ; Meunier, Marine ; Spillmann, Adrian

The oral cholera vaccine WC-rBS consists of 4 different inactivated strains of Vibrio cholerae (LPS source) admixed with recombinant cholera toxin B subunit. Because of its unique composition and anti-inflammatory properties reported for both CTB and low doses of LPS from other Gram-negative bacteria, we speculated that WC-rBS might have anti-inflammatory potential in a chronic autoimmune disease such as inflammatory bowel diseases. First in vitro endotoxin tolerance experiments showed the surprising WC-rBS potential in the modulation of inflammatory responses on both PBMCs and THP1 cells. WC-rBS was further evaluated in the Dextran Sodium Sulfate colitis mouse model. Administrated orally at different dosages, WC-rBS vaccine was safe and showed immunomodulatory properties when administered in a preventive mode (before and during the induction of DSS colitis) as well as in a curative mode (after colitis induction); with improvement of disease activity index (from 27 to 73%) and histological score (from 65 to 88%). Interestingly, the highest therapeutic effect of WC-rBS vaccine was observed with the lowest dosage, showing even better anti-inflammatory properties than mesalamine; an approved 5-aminosalicylic acid drug for treating IBD patients. In summary, this is the first time that a prophylactic medicine, safe and approved for prevention of an infectious disease, showed a benefit in an inflammatory bowel disease model, potentially offering a novel therapeutic modality for IBD patients.

27 Sep 2022·Evidence-Based Complementary and Alternative Medicine

rhCNB Improves Cyclophosphamide-Induced Immunodeficiency in BALB/c Mice

Article

Author: Huang, Hui ; Zhong, Wenhua ; Yang, Zhaoxin ; Chang, Penghuan

Background. This study aims to explore the immunomodulatory effect of rhCNB on mice with cyclophosphamide (CTX)-induced immunodeficiency through TLR4/MAPK pathway. Methods. BALB/c mice were randomly divided into three groups: a negative control group, an immunosuppression model group, and a rhCNB treatment group. Tail vein injection of cyclophosphamide (40 mg/kg) was used to establish a mouse immunosuppression model. Intraperitoneal injection of rhCNB (20 mg/kg) was administered to the treatment group, whereas equal quantities of normal saline were given to the control group and model group. Perform peripheral blood routine of CD4, CD8, and CD19 lymphocyte subsets and peripheral blood Th1/Th2 cell subsets 24 hours after the last administration. RT-PCR was used to detect mRNA levels of TLR4, P38, JNK, T-bet, and GATA3, the spleen immune organ index was measured, and the histopathological status of the spleen and thymus was observed. Results. The results showed that compared with the control group, WBC, PLT, LYM, NEU, immune organ index, CD4+/CD8+ and CD19+ subgroup ratio, and peripheral blood Th1/Th2 cell subgroups decreased in the model group. The mRNA levels of TLR4, P38, JNK, T-bet, and GATA3 decreased compared with the model group, while they increased in the treatment group. Conclusions. rhCNB has an immunomodulatory effect by regulating the expression of Th1/Th2 cytokine balance through the TLR4/MAPK signaling pathway and promoting the differentiation and proliferation of lymphocytes, thereby improving the immune function.

01 Jan 2020·International Journal of Pharmaceutics

The roles of mesoporous silica and carbon nanoparticles in antigen stability and intensity of immune response against recombinant subunit B of cholera toxin in a rabbit animal model

Article

Author: Karimi Bavandpour, Ali ; Bakhshi, Bita ; Najar-Peerayeh, Shahin

Vaccines are the front line in the fight against diseases. However, setbacks with existing cholera vaccines have ignited a considerable effort to develop more suitable vaccine formulations. In this study, we aim to investigate the effect of antigen stability and controlled release in inducing an immune response. Therefore, two types of silica and carbon mesoporous nanoparticles of the same size and shape but different pore architectures were synthesized and loaded with recombinant cholera toxin subunit B to serve as a model for antigen stability and controlled release of antigenic CTB. In order to evaluate immune response efficacy for these model formulations, IgG and IgA responses and fluid accumulation (FA) index were measured in immunized rabbits, which were challenged with wild-type Vibrio cholerae. Our result suggests that mesoporous silica nanoparticles have greater efficacy in inducing mucosal immune responses, and it proved more proficiency in overall immune responses in challenge experiments and FA index (p < 0.05). These findings indicate that mesoporous nanoparticles and, in particular, mesoporous silica nanoparticles, could be used in oral vaccine formulation against cholera.

100 Deals associated with Recombinant human Calcineurin B subunit(Haikou Qili Pharmaceutical)

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Indication	Highest Phase	Country/Location	Organization	Date
Liver Cancer	Phase 2	CN	Haikou Qili Pharmaceutical Co., Ltd.	02 Mar 2021
Liver Cancer	Phase 2	CN	Beijing Normal University	02 Mar 2021
Stomach Cancer	Phase 2	CN	Haikou Qili Pharmaceutical Co., Ltd.	02 Mar 2021
Stomach Cancer	Phase 2	CN	Beijing Normal University	02 Mar 2021

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