This Phase 1/ 2a study is a multicenter study to evaluate the safety, tolerability and efficacy of SCG101 in subjects with hepatitis B virus-related hepatocellular carcinoma

Start Date26 Oct 2022

Sponsor / Collaborator

SCG Cell Therapy Pte. Ltd.

NCT06617000

/ RecruitingPhase 1

A Phase 1, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma

This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.

Start Date25 Oct 2022

Sponsor / Collaborator

SCG Cell Therapy Pte. Ltd.

NCT05339321

/ Unknown statusPhase 1IIT

A Phase 1 Clinical Study of Autologous HBV-specific TCR-T Cell Therapy (SCG101) in Patients With HBV-related HCC

Adoptive cell therapy with TCR-T cells targeting HBV antigens represents an innovative opportunity for treatment of HBV-related HCC. SCG101 is a genetically modified autologous TCR-T cell therapy with a natural high-avidity TCR directed towards the HLA-A*02-restricted HBsAg peptide. This is a phase 1 clinical study of SCG101 alone and with PD-1/PD-L1 checkpoint inhibitors in HBV-related HCC.

Start Date14 Apr 2021

Sponsor / Collaborator

Peking Union Medical College Hospital

100 Clinical Results associated with SCG101

100 Translational Medicine associated with SCG101

100 Patents (Medical) associated with SCG101

Literatures (Medical) associated with SCG101

01 Jan 2026·GUT

Clinical results of an HBV-specific T-cell receptor-T-cell therapy (SCG101) in patients with HBV-related hepatocellular carcinoma treated in an investigator-initiated, interventional trial

Article

Author: Li, Wei ; Du, Shunda ; Liu, Yun-Peng ; Wan, Xueshuai ; Yang, Lu ; Wu, Wei ; Quan, Dongmei ; Zhou, Yuhong ; Wisskirchen, Karin ; Zhang, Xuxu ; Wang, Xiaorui ; Zheng, Mengyao ; Wu, Xiang'an ; Qu, Xiujuan ; Zhang, Ke ; Protzer, Ulrike

Background:

SCG101 is an autologous T-cell therapy specifically targeting hepatitis B virus (HBV) using a natural, high-affinity T-cell receptor that is stably expressed.

Objective:

We evaluated the safety, pharmacokinetics, pharmacodynamics and efficacy of SCG101 in patients with HBV-related hepatocellular carcinoma (HCC) in an investigator-initiated trial.

Design:

Six human leucocyte antigen (HLA)-A*02:01-positive, serum hepatitis B surface antigen (HBsAg)-positive and hepatitis B e antigen-negative patients with advanced HBV-HCC, who had failed one to three prior systemic therapies, received SCG101 at doses of 5×10 7 or 1×10 8 TCR-T + cells/kg three days after lymphodepletion.

Results:

Within 1 week, all patients experienced a significant but transient alanine aminotransferase elevation paralleled by a 76±57 fold expansion of T cells detected in peripheral blood. No neurotoxicity, but a cytokine release syndrome reaching up to grade 3 was observed. However, these side effects were not dose-limiting and could be managed with corticosteroids, anti-interleukin-6 and/or vasopressor therapy. Indicating on-target activity of SCG101, serum HBsAg levels dropped by 1.96 (0.16–3.84) log 10 within 2 weeks. According to modified Response Evaluation Criteria in Solid Tumours, three of the six patients achieved tumour shrinkage with a best percentage change in target lesion size of −19.5%, −74.6% and −100%. One showed complete remission of the target lesion, remaining progression-free for 27 months and one other achieved a durable (>6 months) remission. During follow-up (median 10.9 months), three patients died, and one was lost to follow-up.

Conclusion:

As monotherapy for patients with HBV-HCC, SCG101 demonstrated pronounced antiviral and antitumour activities and a safety profile manageable with supportive care. SCG101’s T-cell expansion, serum HBsAg drop and tumour response collectively underscore on-target activity.

Trial registration number:

NCT05339321 .

01 Oct 2024·Clinical and Molecular Hepatology

Genetically-modified, redirected T cells target hepatitis B surface antigen-positive hepatocytes and hepatocellular carcinoma lesions in a clinical setting

Article

Author: Pang, Yong ; Du, Shunda ; Jin, Tao ; Ma, Christy ; Liu, Fang ; Wu, Yu ; Wisskirchen, Karin ; Li, Qi ; Wan, Xueshuai ; Zhang, Ke ; Wang, Xiaorui ; Protzer, Ulrike ; Yang, Lu ; Wu, Xiang'an

Background/Aims: Hepatitis B virus (HBV)-DNA integration in HBV-related hepatocellular carcinoma (HBV-HCC) can be targeted by HBV-specific T cells. SCG101 is an autologous, HBV-specific T-cell product expressing a T-cell receptor (TCR) after lentiviral transduction recognizing the envelope-derived peptide (S_20-28) on HLA-A2. We here validated its safety and efficacy preclinically and applied it to an HBV-related HCC patient (NCT05339321).Methods: Good Manufacturing Practice-grade manufactured cells were assessed for off-target reactivity and functionality against hepatoma cells. Subsequently, a patient with advanced HBV-HCC (Child-Pugh class A, Barcelona Clinic Liver Cancer stage B, Eastern Cooperative Oncology Group performance status 0, hepatitis B e antigen-, serum hepatitis B surface antigen [HBsAg]+, HBsAg+ hepatocytes 10%) received 7.9×10⁷ cells/kg after lymphodepletion. Safety, T-cell persistence, and antiviral and antitumor efficacy were evaluated.Results: SCG101, produced at high numbers in a closed-bag system, showed HBV-specific functionality against HBV-HCC cells in vitro and in vivo. Clinically, treatment was well tolerated, and all adverse events, including transient hepatic damage, were reversible. On day 3, ALT levels increased to 1,404 U/L, and concurrently, serum HBsAg started decreasing by 3.84 log¹⁰ and remained <1 IU/mL for over six months. HBsAg-expressing hepatocytes in liver biopsies were undetectable after 73 days. The patient achieved a partial response according to modified RECIST with a >70% reduction in target lesion size. Transferred T cells expanded, developed a stem cell-like memory phenotype, and were still detectable after six months in the patient’s blood.Conclusions: SCG101 T-cell therapy showed encouraging efficacy and safety in preclinical models and in a patient with primary HBV-HCC and concomitant chronic hepatitis B with the capability to eliminate HBsAg⁺ cells and achieve sustained tumor control after single dosing.

01 Aug 2023·Hepatology international

Messenger RNA electroporated hepatitis B virus (HBV) antigen-specific T cell receptor (TCR) redirected T cell therapy is well-tolerated in patients with recurrent HBV-related hepatocellular carcinoma post-liver transplantation: results from a phase I trial

Article

Author: Lu‑En Wai ; Jianxi Lu ; Sarene Koh ; Panlong Li ; Xiaofang Zheng ; Fan Yang ; Xiaoyan Chen ; Yunhao Chen ; Tingting Wang ; Qi Zhang ; Wanxin Chen ; Wenjie Chen ; Jintao Cheng ; Cong Du ; Regina Wanju Wong ; Li Yang

BACKGROUND AND AIMS:

Liver transplantation (LT) is the primary curative option for cirrhotic patients with early-stage hepatocellular carcinoma (HCC). However, tumor recurrence occurs in 15-20% of cases with unfavorable prognosis. We have developed a library of T cell receptors (TCRs) specific for different hepatitis B virus (HBV) antigens, restricted by different molecules of human leucocyte antigen (HLA)-class I, to redirect T cells against HBV antigens (Banu in Sci Rep 4:4166, 2014). We further demonstrated that these transiently functional T cells specific for HBV obtained through messenger RNA (mRNA) electroporation can eliminate HCC cells expressing HBV antigens in vitro and in vivo (Kah in J Clin Invest 127:3177-3188, 2017). A phase I clinical trial for patients with HCC recurrence post-liver transplant was conducted to assess the safety, tolerability, and anti-tumor efficacy of transiently functional HBV-TCR T cells. Here, we report the clinical findings with regard to the safety and anti-tumor efficacy of mRNA electroporated HBV-specific TCR-T cells. (ClinicalTrials.gov identifier: NCT02719782).

PATIENTS AND METHODS:

A total of six patients with HBV-positive recurrent HCC post-liver transplant and HLA-matched to TCR targeting hepatitis B surface antigen (HBsAg) or hepatitis B core antigen (HBcAg) (HLA-A*02:01/HBsAg, HLA-A*11:01/HBcAg, HLA-B*58:01/HBsAg or HLA-C*08:01/HBsAg) were enrolled in this study. The primary objective was to assess the safety of short-lived mRNA electroporated HBV-TCR T cells based on the incidence and severity of the adverse event (AE) graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. The secondary objective was to determine the effectiveness of HBV-TCR T cells as per RECIST 1.1 criteria. Patients were followed up for survival for 2 years post-end of treatment.

RESULTS:

The median age of the six patients was 35.5 years (range: 28-47). The median number of HBV-TCR T cell infusions administered was 6.5 (range: 4-12). The treatment-related AE included grade 1 pyrexia. This study reported no cytokine release syndrome nor neurotoxicity. One patient remained alive and five were deceased at the time of the data cutoff (30 April 2020).

CONCLUSION:

This study has demonstrated that multiple infusions of mRNA electroporated HBV-specific TCR T cells were well-tolerated in patients with HBV-positive recurrent HCC post-liver transplant.

News (Medical) associated with SCG101

18 Oct 2025

·www.prnewswire.com

SCG announces presentation of clinical results of SCG142 in patients with HPV-related carcinoma at ESMO 2025

SINGAPORE, Oct. 18, 2025 /PRNewswire/ -- SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company developing next-generation immunotherapies for infectious diseases and their associated cancers, announced the presentation of first-in-human clinical data for SCG142 in an investigator-initiated Phase I trial (NCT06544720) in patients with recurrent or metastatic HPV-associated carcinomas. The poster will be presented at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin, Germany, on Saturday, 18 October 2025. This ongoing first-in-human trial evaluates the safety, tolerability and preliminary efficacy of SCG142, a novel human papillomavirus (HPV) E7-specific T-cell receptor-engineered T (TCR T) cell therapy armoured with a TGFβRII-41BB chimeric switch receptor. Eligible patients are HLA-A*02:01-positive with advanced HPV16- or HPV52-positive carcinomas who have progressed on or were intolerant to at least one prior systemic therapy. Key endpoints include safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity. As of the data cut-off, tumor shrinkage was observed in all seven treated patients, resulting in a disease control rate (DCR) of 100%. Four of the seven patients (57%) achieved >30% tumor reduction, including two confirmed partial responses (PR) and two unconfirmed PRs. No dose-limiting toxicities or serious adverse events were reported. These preliminary findings support continued clinical development of SCG142. "SCG142 is a novel and differentiated HPV-specific TCR T cell therapy with promising clinical activity." said Prof. Dr. Yang Li, Director of Medical Oncology, The First Affiliated Hospital of Guangxi Medical University. "We're excited that tumor shrinkage was observed in all seven treated patients and that SCG142 was well tolerated. These encouraging preliminary findings underscore the potential of SCG142 to provide new solutions for patients in a variety of HPV16 and HPV52 expressing cancers and support further evaluation in larger patient cohorts", she added. SCG142 was isolated with GianTCRTM, SCG's proprietary TCR screening platform with the ability to identify fully natural TCRs with high affinity and high avidity properties as well as potent antiviral and anti-tumor effects against infection-related solid tumors accompanied by a lower risk of off-target toxicity. "We are delighted that the excellent preclinical profile of our HPV-E7-specific TCR - including high avidity and dual functionality in both CD8+ and CD4+ T cells - has translated into clinical activity with SCG142" added Dr. Susanne Wilde, VP, Head of Preclinical Research of SCG Cell Therapy. Besides SCG142, SCG is also advancing SCG101, a hepatitis B virus (HBV)-specific TCR T cell therapy for the treatment of HBV-related hepatocellular carcinoma (HCC). – END – About Human Papillomavirus and Cancers Human papillomavirus (HPV) infection is the most common sexually transmitted infection. Nearly all sexually active people are infected with HPV and around half of these infections occur with a high-risk HPV type, which can lead to cancer development.1 As such, HPV infection accounts for more than 90% of anal and cervical cancers, about 70% of vaginal and vulvar cancers, and 60% of penile and oropharyngeal cancers, and it causes an estimated 690,000 cancers worldwide each year[1],[2]. About SCG Cell Therapy SCG is a leading biotechnology company focusing on the development of novel immunotherapies in infections and its associated cancers. The company targets the most common cancer-causing infections: HPV, HBV and EBV, and develops a broad and unique pipeline of TCR-based cellular immunotherapy products against infection- associated cancers. With the proprietary GianTCRTM TCR screening platform, in house viral vector production and AutoCellTM, a fully closed, automatic and low-cost cell therapy manufacturing system, the company covers the entire value chain from new target research and discovery, manufacturing, and clinical development. For more information about SCG, please visit us at . SOURCE SCG Cell Therapy Pte Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyPhase 1Cell TherapyClinical Result

08 Jul 2025

·www.prnewswire.com

SCG Cell Therapy Announces Clearance of Investigational New Drug Application by the China NMPA for SCG101V

SINGAPORE, July 7, 2025 /PRNewswire/ -- SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company pioneering TCR T cell therapy for infectious diseases and associated cancers, announced today that the China National Medical Products Administration (NMPA) has cleared the Investigational New Drug (IND) application for SCG101V, marking the first-ever investigational cell therapy to enter regulatory approved Phase 1/2 clinical trial for chronic hepatitis B virus (HBV) infection. SCG101 is designed to cure chronic hepatitis B by eliminating HBV cccDNA and HBV-DNA integration within HBV-infected hepatocytes, which are the fundamental source of persistent infection and antigen production. These infected hepatocytes serve as the long-term viral reservoir that current antiviral therapies fail to eradicate. "SCG101 is designed to mimic the natural immune response observed in individuals who are able to clear HBV infection spontaneously. HBV-specific T cells play a central role in this process and, remarkably, through genetic engineering of T cells, we were able to replicate this natural process as demonstrated in our preclinical models and clinical data in hepatocellular carcinoma, providing strong evidence that this promise holds true in hepatitis B patients", said Professor Ulrike Protzer, Scientific Founder of SCG Cell Therapy and Director of Institute of Virology Technical University of Munich / Helmholtz Munich. In Phase 1 clinical trial of SCG101 in patients with HBV-related hepatocellular carcinoma (HCC), SCG101 demonstrated a good safety profile and sustained clearance of serum hepatitis B surface antigen (HBsAg), even in heavily pre-treated patients. Among the treated patients, 94% of patients had previously received nucleoside analogue (NA) antiviral therapy, and 72% presented with baseline liver cirrhosis. Following a single infusion of SCG101, all patients experienced a rapid decline in HBsAg level. Notably, 94% achieved a 1.0–4.6 log₁₀ reduction in HBsAg within 28 days, with HBsAg levels remained <100 IU/mL for up to one year without rebound. Furthermore, 23% of patients achieved complete HBsAg loss, a critical benchmark for a cure. Professor Niu Jinqi, Vice President and Chief Physician of The First Hospital of Jilin University, commented: "SCG101 has demonstrated significant breakthrough potential in HBV-related liver cancer, remarkably, achieving HBsAg loss following a single dose. This IND approval by the NMPA marks a pioneering step toward a functional cure for chronic hepatitis B. We are excited about the prospects of this therapy and the benefit it could bring to millions of patients, helping to reduce the burden of liver disease in China and globally". Chronic HBV infection affects an estimated 300 million people globally and is a leading cause of liver cirrhosis and hepatocellular carcinoma, contributing to more than 820,000 deaths each year. While current standard-of-care therapies can suppress viral replication, they rarely achieve a functional cure and therefore cannot fundamentally halt disease progression. "This IND clearance represents a historic milestone—not only for SCG but for the broader field of hepatitis B treatment. With indications across HBV-related hepatocellular carcinoma, HBV-related cholangiocarcinoma, and chronic hepatitis B, this IND clearance further validates our development strategy—expanding from virus-induced cancers to chronic infectious diseases", said Christy Ma, Chief Executive Officer of SCG Cell Therapy. "SCG101 is the first cell therapy product to receive regulatory approval to enter a Phase 1/2 clinical trial specifically for HBV and HBV-induced cancer, and we are proud to lead the way in advancing toward a long-term functional cure. We remain on track for initiation of a pivotal study, following the recent completion of our Phase 1 study in patients with HBV-HCC. We look forward to sharing additional clinical data as we continue to push the boundaries of what's possible in cell therapy." – END – About SCG101 SCG101 is an investigational autologous T cell receptor (TCR) T cell therapy designed to selectively target specific epitope of the hepatitis B surface antigen (HBsAg). Powered by SCG's proprietary GianTCR™ screening platform, which enables the discovery of natural, high-affinity, high-avidity TCRs against intracellular antigens presented via the major histocompatibility complex (MHC). SCG101 delivers precise immune-mediated clearance of infected and malignant cells demonstrating significant tumour inhibition and the eradication of HBV covalently closed circular DNA (cccDNA) in preclinical and clinical studies. About HBV Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection is a major global health issue, affecting nearly 300 million people across the world. Approximately 1.1 million people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options. About SCG Cell Therapy SCG Cell Therapy is a leading biotechnology company dedicated to developing novel immunotherapies for infectious diseases and associated cancers. The company focuses on targeting some of the most common cancer-causing infections, including Helicobacter pylori, HPV, HBV, and EBV. SCG is advancing a broad pipeline of TCR-based therapeutics aimed at preventing and curing infection-related cancers. Headquartered in Singapore, SCG operates across Singapore, China, and Germany, leveraging regional strengths to cover the entire value chain, from innovative drug research and discovery to manufacturing, clinical development, and commercialization. For more information, please visit . SOURCE SCG Cell Therapy Pte Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Cell TherapyImmunotherapyPhase 1INDClinical Result

28 Nov 2024

·pipelinereview.com

SCG Cell Therapy Presents Promising Phase 1 Data for a Novel HBV-Specific TCR-T Therapy (SCG101) at the AASLD Liver Meeting 2024

SINGAPORE I November 25, 2024 I SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company focused on developing innovative immunotherapies for infectious diseases and associated cancers, announced late-breaking data from its Phase 1 trial of SCG101, a first-in-class autologous hepatitis B virus (HBV)-specific T-cell receptor-engineered T Cell (TCR-T) therapy targeting hepatitis B surface antigen (HBsAg). The data was presented at the 2024 AASLD Liver Meeting in San Diego, United States. In the Phase 1 clinical trial, SCG101 exhibited promising antiviral activity in patients with advanced HBV-related hepatocellular carcinoma (HBV-HCC). Among the 12 patients treated with a single intravenous dose of SCG101 at 5.0×10 7 ~ 1.0×10 8 TCR + T cells/kg, all patients demonstrated a significant reduction in serum HBsAg levels, with 11 out of 12 (92%) patients achieving a reduction of 1.0 to 4.6 log 10 , and the levels remaining below 100 IU/mL throughout the follow-up period of up to one year. Notably, four patients (33%) experienced HBsAg loss within 21 days following a single infusion of SCG101 and which persisted throughout the follow-up. The safety profile of SCG101 was generally favourable, with the therapy being well tolerated. The most commonly reported treatment-related adverse events included transient elevations in liver enzymes, pyrexia, cytopenia, cytokine release syndrome (CRS), hypoalbuminemia, and hyponatremia—consistent with SCG101’s mechanism of action, which involves the HBsAg-targeted immune activation and its mediated clearance of diseased hepatocytes and HCC cells. HBV remains a major global health burden, affecting over 250 million people worldwide. It is a leading cause of liver cancer, responsible for 50%–80% of hepatocellular carcinoma cases globally. 1 Chronic HBV infection leads to the integration of HBV DNA into the host genome, resulting in persistent HBsAg expression, chromosomal instability, and activation of oncogenes, thereby contributing to the development of hepatocellular carcinoma. 2 SCG101 is designed to target a specific HBV peptide presented on infected cells, as well as hepatocytes with HBV DNA integration. By triggering both cytolytic and non-cytolytic mechanisms, SCG101 effectively eliminates HBV-infected hepatocytes as well as premalignant and HBV-HCC cells with HBV-DNA integration. “The positive data from our Phase 1 trial marks a significant milestone in the development of SCG101, our first-in-class HBV-specific TCR-T therapy. These results not only demonstrate the potential of SCG101 to achieve meaningful and durable antiviral responses in patients, but also underscore the unique approach we are taking in HBV-specific TCR T cell therapy. We are encouraged by these early findings and are committed to advancing SCG101 through clinical development as we work towards providing a new therapeutic option for patients suffering from this challenging disease”, said Christy Ma, Chief Executive Officer of SCG Cell Therapy. “We believe our GianT TM TCR discovery platform has the potential to address a broad spectrum of infection-associated cancers, such as human papillomavirus (HPV) associated cervical cancer and head and neck cancer, and Epstein-Barr virus (EBV) associated nasopharyngeal carcinoma and gastric cancer, paving the way for a new paradigm in immune-based cancer treatment”. About SCG101 SCG101 is an investigational autologous T-cell receptor (TCR) T cell therapy that targets a specific epitope of the hepatitis B surface antigen (HBsAg). Leveraging SCG’s proprietary GianT TM technology, our TCR screening platform identifies high-affinity and high-avidity natural TCRs against intracellular antigens presented via the major histocompatibility complex (MHC) in solid tumors. Both preclinical and clinical studies of SCG101 have demonstrated significant tumor inhibition and the eradication of HBV covalently closed circular DNA (cccDNA). SCG101 has received clinical trial approvals from the U.S. Food and Drug Administration (FDA), the China National Medical Products Administration (NMPA), the Singapore Health Sciences Authority (HSA), and the Hong Kong Department of Health (DOH) for the treatment of patients with HBV-related hepatocellular carcinoma (HCC). A Phase 1/2 clinical trial evaluating SCG101 is currently underway (NCT05417932). About Hepatocellular carcinoma Hepatocellular carcinoma (HCC) is the most common type of liver cancer. In 2020, it was estimated that over 905,000 new cases of liver cancer were diagnosed, and more than 830,100 deaths occurred globally, making it one of the leading causes of cancer-related mortality. 3 Chronic hepatitis B virus (HBV) infection is responsible for at least 50% of HCC cases worldwide. 1 HCC is typically diagnosed at an advanced stage, contributing to a poor prognosis with a five-year survival rate of less than 15%. 4 About SCG Cell Therapy SCG Cell Therapy is a leading biotechnology company dedicated to developing novel immunotherapies for infectious diseases and associated cancers. The company focuses on targeting some of the most common cancer-causing infections, including Helicobacter pylori, HPV, HBV, and EBV. SCG is advancing a broad pipeline of TCR-based therapeutics aimed at preventing and curing infection-related cancers. Headquartered in Singapore, SCG operates across Singapore, China, and Germany, leveraging regional strengths to cover the entire value chain, from innovative drug research and discovery to manufacturing, clinical development, and commercialization. For more information, please visit www.scgcell.com . [1] Y, Xie. (2017). Hepatitis B virus-associated hepatocellular carcinoma. Advances in experimental medicine and biology. [2] Jiang, Y., Han, Q., Zhao, H., Zhang, J. (2021, May 20). The mechanisms of HBV-induced hepatocellular carcinoma. Journal of hepatocellular carcinoma. [3] Liver cancer statistics: World cancer research fund international. WCRF International. (2022, April 14). [4] Golabi P, Fazel S, Otgonsuren M, Sayiner M, Locklear CT, Younossi ZM. (2017). Mortality assessment of patients with hepatocellular carcinoma according to underlying disease and treatment modalities. SOURCE: SCG Cell Therapy

ImmunotherapyCell TherapyPhase 1Clinical ResultAACR

100 Deals associated with SCG101

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis B, Chronic	Phase 2	China	Xinghande Biomedical (Shanghai) Co., Ltd.	24 Jul 2026
Hepatitis B	Phase 2	United States	SCG Cell Therapy Pte. Ltd.	26 Oct 2022
Hepatitis B	Phase 2	Hong Kong	SCG Cell Therapy Pte. Ltd.	26 Oct 2022
Hepatitis B	Phase 2	Singapore	SCG Cell Therapy Pte. Ltd.	26 Oct 2022
Hepatitis B Virus-Related Hepatocellular Carcinoma	Phase 2	United States	SCG Cell Therapy Pte. Ltd.	26 Oct 2022
Hepatitis B Virus-Related Hepatocellular Carcinoma	Phase 2	Hong Kong	SCG Cell Therapy Pte. Ltd.	26 Oct 2022
Hepatitis B Virus-Related Hepatocellular Carcinoma	Phase 2	Singapore	SCG Cell Therapy Pte. Ltd.	26 Oct 2022
Intrahepatic Cholangiocarcinoma	IND Approval	China	Xinghande Biomedical (Shanghai) Co., Ltd.	23 Nov 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06617000 (PRNewswire) Manual	Phase 1	Hepatitis B Virus-Related Hepatocellular Carcinoma	17	SCG101	frdygbzghq(ipvpffovwr) = dbkcttfixt bqnrwwlmju (ljzserfjjr ) View more	Positive	07 May 2025
NCT06617000 (PRNewswire) Manual	Phase 1	Hepatitis B Virus-Related Hepatocellular Carcinoma	12	SCG101	wrfqfsmfvs(zlebybudnd) = wzzbxvvdrc xbtqhhnvmt (wvyfshvlsf )	Positive	24 Nov 2024
CTR20222173 (PRNewswire) Manual	Phase 1	Liver Cancer	6	SCG101	lqkhijpamq(fsyzrwhgvs) = kporfxfdkj jofqevilua (dpblhkkcqa ) View more	Positive	07 Jun 2024
NCT06617000 (PRNewswire) Manual	Phase 1	Advanced Hepatocellular Carcinoma	-	SCG101	oskpvaqwwt(kelppoqynp) = generally well tolerated with no cases of serious adverse events or immune effector cell-associated neurotoxicity syndrome. The most common treatment-related adverse events were transient liver enzymes evaluation, cytokine release syndrome (CRS), and fever libfzvqnri (jqaajajlcj )	Positive	13 Nov 2023
NCT06617000 (PRNewswire) Manual	Phase 1	Advanced Hepatocellular Carcinoma	-	SCG101 (HBsAg reduction >1 log)		Positive	13 Nov 2023
PRNewswire Manual	Not Applicable	Hepatocellular Carcinoma	-	SCG101	hsfwlemvdy(kiwccqhcyq) = qltoclscsa vzcpdutnjf (uuoomlpkwd ) View more	Positive	05 Jun 2023
NCT05339321 (PRNewswire) Manual	Phase 1	Hepatitis B \| Liver Cancer	3	SCG101	llcsugmmwt(tsfycmrhqs) = whhbjbvsyd gihcbquudm (jyvgvovhkr )	Positive	23 Jun 2022

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