A Phase III Multinational, Multicenter, Observer-Blinded, Randomized, Active-Controlled Trial to Evaluate the Immunogenicity and Safety of the Preventive COVID-19 Vaccine AdCLD-CoV19-1 OMI Administered as a Booster to Adults Aged 19 Years Old and Above

The immunogenicity and safety of AdCLD-CoV19-1 OMI (5.0x10^10 VP (0.5 mL)/dose/Vial) administered as a booster in healthy adults aged 19 years old and above will be evaluated. Outcome assessment will be performed in comparison with Comirnaty Bivalent.

开始日期2023-11-27

申办/合作机构

Cellid Co., Ltd.

NCT05576623 / Completed临床1/2期

A Phase I/II (Single Center, Open, Phase I and Multicenter, Double-Blinded, Randomized, Placebo-Controlled, Phase II) Trial to Evaluate the Safety and Immunogenicity of the AdCLD-CoV19-1 OMI Administered as a Booster to Healthy Adults Aged 19 Years Old and Above

The safety and immunogenicity of AdCLD-CoV19-1 OMI (5.0x10^10 VP (0.5 mL)/dose/Vial) administered as a booster in healthy adults aged 19 years old and above will be evaluated.

开始日期2022-09-14

申办/合作机构

Cellid Co., Ltd.

NCT05520970 / Terminated临床2期

A Phase IIb, Multicenter, Observer-Blinded, Randomized, Placebo-Controlled Trial to Evaluate the Immunogenicity and Safety of the AdCLD-CoV19-1 in Healthy Adults Aged 19 Years Old and Above

The immunogenicity and safety profiles of AdCLD-CoV19-1 (5.0×10^10 VP/dose) will be assessed for 1-dose or 2-dose regimen in SARS-CoV-2 seronegative healthy adults.

开始日期2022-08-19

申办/合作机构

Cellid Co., Ltd.

[+1]

100 项与 Cellid Co., Ltd. 相关的临床结果

登录后查看更多信息

0 项与 Cellid Co., Ltd. 相关的专利（医药）

登录后查看更多信息

项与 Cellid Co., Ltd. 相关的文献（医药）

2024-06-01·Journal of Clinical Oncology

An open label, single arm phase II, multicenter trial of durvalumab and BVAC-C, in patients with HPV 16- or 18-positive cervical cancer and failure of first-line platinum-based chemotherapy (DURBAC).

作者: Song, By-yeong ; Choi, Chel Hun ; Kang, Chang-Yuil ; Lee, Jung-Yun ; Kim, Dae-Yeon ; Kim, Tae-Joong ; Kim, Byoung-Gie ; Cho, Duck ; Lee, Jeong-Won ; Song, Sang Yong ; Park, Byoung-Kwan Hun ; Shin, Kwang-Soo ; Lim, Myong Cheol ; Lee, Yoo-Young ; Jeon, Insu ; Kim, Wuhyun ; Kim, Hee Seung ; Kim, Kidong

5513 Background: In the phase I/IIa study of HPV positive recurrent cervical carcinoma, BVAC-C, a pioneering B cell- and monocyte-based immunotherapeutic vaccine transfected with recombinant E6/E7 gene of HPV type 16/18, demonstrated favorable tolerability. The ongoing phase 2 clinical trial investigates the potential synergistic effects of combining BVAC-C with durvalumab (MEDI4736), an anti-PD-L1 therapy, to enhance anti-tumor immune responses. Methods: The trial comprises two parts. Part A, utilizing a 3+3 dose-escalation design, assesses BVAC-C combined with 1500 mg durvalumab to establish the maximum tolerated dose (MTD) and recommended dose for Part B. Part B, with an expansion phase involving up to 25 patients, focuses on safety and clinical efficacy, measured by the 6-month progression-free survival (PFS) rate. Part A enrollment commenced in September 2021 across six Korean centers, with 9 participants enrolled and MTD determined by November 2022. 25 patients were enrolled in Part B enrollment was completed with 25 patients by December 2023. Tumor response evaluation follows RECIST 1.1 criteria and iRECIST. The essential eligibility criteria comprise histologically confirmed cervical carcinoma with HPV 16/18 positivity, recurrence following or resistance to a solitary prior first-line platinum-based chemotherapy ± bevacizumab, lack of prior exposure to immune-oncology (IO) drugs, and the presence of measurable disease according to RECIST v1.1. Results: Among 29 patients available for this interim analysis, 6-month PFS-rate was 51% (95% CI 33 – 77). The objective response rate (ORR) was 29.2% (7/24), with 2 complete responses. The disease control rate (DCR) was 66.7% (16/24). With a median follow up of 7 months, the median duration of response (DOR) and PFS were not reached. All evaluated patients exhibited inflammatory cytokine responses (IFN-γ or TNF-α) and robust E6/E7-specific T cell responses following BVAC-C vaccinations. Notably, immune responses correlated with clinical outcomes. The most common treatment-emergent adverse events (TEAEs) were pyrexia and myalgia, mostly grade 1 and manageable. Conclusions: The combination of BVAC-C and durvalumab demonstrates promise as a second-line treatment option with a manageable safety profile for patients with recurrent HPV 16/18 positive cervical cancer. The survival data is scheduled to receive an update during the upcoming ASCO meeting. Further studies are warranted to identify potential biomarkers of treatment response. Clinical trial information: NCT04800978 .

2024-03-01·International Journal of Antimicrobial Agents

Boosting with variant-matched adenovirus-based vaccines promotes neutralizing antibody responses against SARS-CoV-2 Omicron sublineages in mice

Article

作者: Chang, Soojeong ; Kim, Jae-Ouk ; Park, Hyemin ; Han, Sang Jun ; Jung, In Kyung ; Shin, Jieun ; Kang, Chang-Yuil ; Park, Seowoo ; Kim, Jong Heon ; Kim, Byung-Seok ; Park, Bongju ; Shin, Kwang-Soo ; Lee, Tae-Young ; Lee, Jung-Ah

Global spread of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) Omicron subvariants, such as BA.4, BA.5 and XBB.1.5, has been leading the recent wave of coronavirus disease 2019 (COVID-19). Unique mutations in the spike proteins of these emerging Omicron subvariants caused immune evasion from the pre-existing protective immunity induced by vaccination or natural infection. Previously, we developed AdCLD-CoV19-1, a non-replicating recombinant adenoviral vector that encodes the receptor binding domain of the spike protein of the ancestral SARS-CoV-2 strain. Based on the same recombinant adenoviral vector platform, updated vaccines that cover unique mutations found in each Omicron subvariant, including BA.1, BA.2, BA.4.1 and BA.5, were constructed. Preclinical studies revealed that each updated vaccine as a booster shot following primary vaccination targeting the ancestral strain improved neutralizing antibody responses against the pseudovirus of its respective strain most effectively. Of note, boosting with a vaccine targeting the BA.1 or BA.2 Omicron subvariant was most effective in neutralization against the pseudovirus of the BA.2.75 strain, whereas BA.4.1/5-adapted booster shots were most effective in neutralization against the BQ.1, BQ1.1 and BF.7 strains. Therefore, it is imperative to develop a vaccination strategy that can cover the unique spike mutations of currently circulating Omicron subvariants in order to prevent the next wave of COVID-19.

2024-01-15·Cancer Research and Treatment

First-in-Human Phase 1 Study of a B Cell– and Monocyte-Based Immunotherapeutic Vaccine against HER2-Positive Advanced Gastric Cancer

Article

作者: Choi, Ki-Young ; Kang, Chang-Yuil ; Lee, Jii Bum ; Kim, Hyun Ok ; Kwon, Woo Sun ; Kim, Sinyoung ; Park, Myunghwan ; Rha, Sun Young ; Chung, Hyun Cheol ; Kim, Wuhyun ; Kim, Hyo Song ; Oh, Taegwon ; Jung, Minkyu

Purpose BVAC-B is an autologous B cell– and monocyte-based immunotherapeutic vaccine that contains cells transfected with a recombinant human epidermal growth factor receptor 2 (HER2) gene and loaded with the natural killer T cell ligand alpha-galactosylceramide. Here, we report the first BVAC-B study in patients with HER2-positive advanced gastric cancer.Materials and Methods Patients with advanced gastric cancer refractory to standard treatment with HER2+ immunohistochemistry ≥ 1 were eligible for treatment. Patients were administered low (2.5×107 cells/dose), medium (5.0×107 cells/dose), or high dose (1.0×108 cells/dose) of BVAC-B intravenously four times every 4 weeks. Primary endpoints included safety and maximum tolerated BVAC-B dose. Secondary endpoints included preliminary clinical efficacy and BVAC-B-induced immune responses.Results Eight patients were treated with BVAC-B at low (n=1), medium (n=1), and high doses (n=6). No dose-limiting toxicity was observed, while treatment-related adverse events (TRAEs) were observed in patients treated with medium and high doses. The most common TRAEs were grade 1 (n=2) and grade 2 (n=2) fever. Out of the six patients treated with high-dose BVAC-B, three had stable disease with no response. Interferon gamma, tumor necrosis factor-α, and interleukin-6 increased after BVAC-B treatment in all patients with medium and high dose, and HER2-specific antibody was detected in some patients.Conclusion BVAC-B monotherapy had a safe toxicity profile with limited clinical activity; however, it activated immune cells in heavily pretreated patients with HER2-positive gastric cancer. Earlier treatment with BVAC-B and combination therapy is warranted for evaluation of clinical efficacy.

100 项与 Cellid Co., Ltd. 相关的药物交易

登录后查看更多信息

100 项与 Cellid Co., Ltd. 相关的转化医学

登录后查看更多信息

组织架构

使用我们的机构树数据加速您的研究。

或

查看完整样例数据

管线布局

2024年12月26日管线快照

管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期

临床3期

其他

登录后查看更多信息

当前项目

药物(靶点)	适应症	全球最高研发状态

AdCLD-CoV19(Cellid) ( SARS-CoV-2 S protein )	新型冠状病毒感染更多	临床3期
BVAC-Neo	肿瘤更多	无进展
BVAC-P ( ACP3 x PSMA )	肾细胞癌更多	无进展
BVAC-B ( HER2 )	复发性胃癌更多	无进展
BVAC-M ( MAGEA3 x gp100 )	黑色素瘤更多	无进展