Primary objective: To evaluate the safety and tolerability of E10H administered by intravenous infusion and dose escalation in patients with advanced gastrointestinal cancer. Secondary objectives: 1) To evaluate the preliminary efficacy of E10H administered by intravenous infusion in patients with advanced gastrointestinal cancer. 2) To evaluate the pharmacokinetic/pharmacodynamic (PK/PD) characteristics of E10H administered by intravenous infusion in patients with advanced gastrointestinal cancer.

Start Date18 Nov 2022

Sponsor / Collaborator

Guangzhou Doublle Bioproduct Co., Ltd.

JPRN-UMIN000014072 / RecruitingPhase 1/2IIT

A phase I/II clinical study of expanded autologous NK cell combined with rituximab-based chemotherapy in patients with CD20 positive B-cell lymphoma - A phase I/II clinical study of expanded autologous NK cell combined with rituximab-based chemotherapy in patients with B-cell lymphoma

Start Date01 Jun 2014

Sponsor / Collaborator-

100 Clinical Results associated with Autologous NK cell(Guangzhou DoublleBioproduct)

100 Translational Medicine associated with Autologous NK cell(Guangzhou DoublleBioproduct)

100 Patents (Medical) associated with Autologous NK cell(Guangzhou DoublleBioproduct)

Literatures (Medical) associated with Autologous NK cell(Guangzhou DoublleBioproduct)

Frontiers in Immunology

Sintilimab plus autologous NK cells as second-line treatment for advanced non-small-cell lung cancer previous treated with platinum-containing chemotherapy

Article

Author: Cui, Jiuwei ; Lu, Jin ; Xu, Yinghui ; Chen, Xiao ; Chen, Naifei ; Liu, Zengguang ; Cong, Xiaofeng ; Liu, Ziling ; Zhao, Yuguang ; Jia, Lin ; Cui, Guozhen ; Ma, Kewei ; Wang, Xu ; Song, Wei ; Niu, Chao ; Yang, Lei ; Chen, Chen ; Chen, Rongrong ; Li, Wei ; Wang, Nanya

This pilot study (NCT03958097; https://www.clinicaltrials.gov/ct2/show/NCT03958097) was aimed to evaluate the efficacy and safety of PD-1 antibody combined autologous NK cells in the treatment of patients with stage IIIB/IIIC or IV non-small-cell lung cancer (NSCLC) who failed the first-line platinum-based chemotherapy. All patients received both sintilimab 200mg and 3×109 NK cells every 3 weeks. 20 patients were enrolled, median follow up time was 22.6 months. The median PFS was 11.6 months, ORR was 45%. Median OS was 17.7 months, 6-month OS rate and 12-month OS rate was 95.0% and 80.0%. Unexpected adverse events were not observed. 2 patients reported grade 3 adverse events (hypertriglyceridemia, neutropenia and increased creatine kinase). The autologous NK cells did not add extra adverse events to the ICI treatment. Autologous NK plus sintilimab showed promising antitumor activity and an acceptable safety profile in advanced driven-mutation negative NSCLC who failed on the first line treatment.

100 Deals associated with Autologous NK cell(Guangzhou DoublleBioproduct)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Colorectal Cancer	Phase 1	CN	Guangzhou Doublle Bioproduct Co., Ltd.	18 Nov 2022
Stomach Cancer	Phase 1	CN	Guangzhou Doublle Bioproduct Co., Ltd.	18 Nov 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2013	Phase 2	Advanced Lung Non-Small Cell Carcinoma Second line \| Third line	19	Autologous ex vivo expanded NK cell-enriched lymphocytes + Docetaxel	(smfjooqizn) = awdqajibel tnylsbvpif (shegmmmadr ) View more	-	20 May 2013
				Docetaxel	(smfjooqizn) = ptvpnjodku tnylsbvpif (shegmmmadr ) View more

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