[Translation] An open-label, dose-escalation Phase I clinical study to evaluate the safety, tolerability, efficacy, and pharmacodynamics of CUD002 injection in subjects with refractory/resistant recurrent ovarian cancer

主要目的：评价CUD002注射液在难治性/耐药复发性卵巢癌受试者中的安全性和耐受性，并确定最大耐受剂量/推荐扩展剂量；次要目的：评价CUD002注射液在难治性/耐药复发性卵巢癌受试者中的药效动力学、免疫原性特征；探索性目的：评估抗肿瘤疗效；分析肿瘤标记物与疗效指标的关系。

[Translation]

Primary purpose: To evaluate the safety and tolerability of CUD002 injection in subjects with refractory/resistant recurrent ovarian cancer and determine the maximum tolerated dose/recommended extended dose; Secondary purpose: To evaluate the pharmacodynamics and immunogenicity characteristics of CUD002 injection in subjects with refractory/resistant recurrent ovarian cancer; Exploratory purpose: To evaluate the anti-tumor efficacy; to analyze the relationship between tumor markers and efficacy indicators.

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Sponsor / Collaborator

Sichuan Cunde Therapeutics Co., Ltd.Startup

100 Clinical Results associated with CUD002

100 Translational Medicine associated with CUD002

100 Patents (Medical) associated with CUD002

Literatures (Medical) associated with CUD002

01 Feb 2024·Cytotherapy

A critical time window for leukapheresis product transportation to manufacture clinical-grade dendritic cells with optimal anti-tumor activities

Article

Author: Li, Qintong ; Meng, Xiangjun ; Lei, Tingjun ; Wang, Wenxiang ; Yuan, Yuan ; Gao, Li ; Ding, Ping ; Jiang, Jinfeng ; Yin, Rutie ; Yang, Chao

BACKGROUND AIMSDendritic cell (DC)-based immunotherapy is a promising approach to treat cancer. However, key aspects governing the reproducible manufacturing of high-quality DC remain incompletely defined. Here, we show that the time window between leukapheresis and DC manufacturing is critical.METHODSTranscriptomic profiling by RNA-seq was used to unbiasedly characterize cellular states during each step of DC manufacturing process, and functional assays were used to determine the anti-tumor activities of DC.RESULTSDuring preclinical development of a DC-based cytotherapy platform, CUD-002 (NCT05270720), we found that DC quality varied among different batches, even though commonly used DC maturation markers CD80, CD83 and CD86 were indistinguishable. Multivariate analysis indicated that DC quality was negatively associated with the shipping time from the leukapheresis site to the manufacturing center. To investigate the potential effect of shipping time, we stored leukapheresis materials from three donors for 0, 1, 2 or 3 days before DC manufacturing. For each step, we carried out RNA-seq analysis to unbiasedly characterize cellular states. Integrated bioinformatic analyses indicated that longer storage time reduced the expression of several transcription factors to attenuate interferon pathways.CONCLUSIONSConsistently, we found that 3-day storage of leukapheresis materials significantly lowered the efficiency to generate DC but also impaired DC responses to inflammatory signals, resulting in inferior antigen-presentation and cytotoxic T-cell activities. Thus, we recommend using leukapheresis materials within 48 h to manufacture therapeutic DCs.

01 Feb 2023·Cytotherapy

Development of a personalized dendritic cell vaccine and single-cell RNA sequencing–guided assessment of its cell type composition

Article

Author: Yin, Rutie ; Li, Qingli ; Yang, Chao ; Zhu, Xiaofeng ; Li, Ping ; Ding, Ping ; Li, Qintong ; Lei, Tingjun ; Tian, Huan ; Jiang, Jinfeng ; Bai, Peng

BACKGROUND AIMSDendritic cell (DC)-based immunotherapy is a promising approach to treat cancer; however, there is no consensus on the manufacturing processes. Cell type heterogeneity in products manufactured by various methods is understudied and may elicit safety concerns from the regulatory perspective.METHODSWe characterized the cell type composition of a recently developed DC vaccine, CUD-002, consisting of DCs loaded with mRNA encoding personalized tumor neoantigens (NCT05270720).RESULTSUsing single-cell transcriptomic analysis as an unbiased approach, we found that >80% cells in the final product were DCs and the rest primarily comprised myelocytes and lymphocytes. Subsequent fluorescence-activated cell sorting analyses confirmed these cellular identities. These results indicate that unintended cells originate from leukapheresis, the first step of the manufacturing process, and thus likely safe. Consistently, no overt toxicity or tumorigenicity was observed in mice inoculated with CUD-002.CONCLUSIONSConsidering that leukapheresis is a widely used procedure for collecting diverse peripheral blood cell types to manufacture various cytotherapies, this study establishes a workflow to analyze and address regulatory considerations on cell type heterogeneity.

100 Deals associated with CUD002

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent ovarian cancer	Phase 1	CN	Sichuan Cunde Therapeutics Co., Ltd.Startup	29 May 2024
Refractory Ovarian Carcinoma	IND Approval	CN	Sichuan Cunde Therapeutics Co., Ltd.Startup	13 Sep 2023

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