A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related
Launched by SCG CELL THERAPY PTE. LTD. · Sep 25, 2024

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Nctid: NCT06617000

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(cyclophosphamide and fludarabine)\n* Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation"}, "identificationModule"=>{"nctId"=>"NCT06617000", "briefTitle"=>"A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"SCG Cell Therapy Pte. Ltd."}, "officialTitle"=>"A Phase 1, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma", "orgStudyIdInfo"=>{"id"=>"SCG-101-CR-102"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"SCG101", "interventionNames"=>["Biological: SCG101"]}], "interventions"=>[{"name"=>"SCG101", "type"=>"BIOLOGICAL", "description"=>"Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.", "armGroupLabels"=>["SCG101"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"100020", "city"=>"Beijing", "state"=>"Beijing", "status"=>"RECRUITING", "country"=>"China", "facility"=>"Beijing", "geoPoint"=>{"lat"=>39.9075, "lon"=>116.39723}}, {"zip"=>"510000", "city"=>"Guangzhou", "state"=>"Guangdong", "status"=>"RECRUITING", "country"=>"China", "facility"=>"Guangzhou", "geoPoint"=>{"lat"=>23.11667, "lon"=>113.25}}, {"zip"=>"450003", "city"=>"Zhengzhou", "state"=>"Henan", "status"=>"RECRUITING", "country"=>"China", "facility"=>"Zhengzhou", "geoPoint"=>{"lat"=>34.75778, "lon"=>113.64861}}, {"zip"=>"130000", "city"=>"Chang chun", "state"=>"Jilin", "status"=>"RECRUITING", "country"=>"China", "facility"=>"Changchun", "geoPoint"=>{"lat"=>42.74694, "lon"=>126.24667}}, {"zip"=>"110000", "city"=>"Shenyang", "state"=>"Liaoning", "status"=>"RECRUITING", "country"=>"China", "facility"=>"Shenyang", "geoPoint"=>{"lat"=>41.79222, "lon"=>123.43278}}, {"zip"=>"250000", "city"=>"Ji'nan", "state"=>"Shandong", "status"=>"RECRUITING", "country"=>"China", "facility"=>"Ji'nan", "geoPoint"=>{"lat"=>36.66833, "lon"=>116.99722}}, {"zip"=>"200000", "city"=>"Shanghai", "state"=>"Shanghai", "status"=>"RECRUITING", "country"=>"China", "facility"=>"Shanghai", "geoPoint"=>{"lat"=>31.22222, "lon"=>121.45806}}], "centralContacts"=>[{"name"=>"SCG Cell Therapy", "role"=>"CONTACT", "email"=>"clinicaltrials@scgcell.com", "phone"=>"021-50339500"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"SCG Cell Therapy Pte. Ltd.", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}

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Trial Information

Current as of December 21, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called SCG101 TCR-T Cell Therapy for patients with Hepatitis B virus-related liver cancer, specifically a type known as Hepatocellular Carcinoma (HCC). The main goal of this study is to see how safe the treatment is, how well it works, and how well patients can tolerate it. The trial is currently looking for participants between the ages of 18 and 75 who have been diagnosed with HCC and have had standard treatments in the past. To be eligible, patients must have certain health conditions and lab results, including a specific type of immune marker, and should not have any other major health issues that could complicate their participation.

Participants in this trial can expect to receive the SCG101 treatment and will be monitored closely by medical staff to ensure their safety and to assess how well the treatment is working. It's important to note that this is an early-stage trial, meaning it’s one of the first steps in testing this new therapy. If you or a loved one meet the eligibility criteria and are interested, discussing this opportunity with a healthcare provider may be a good next step.

Gender

ALL

Eligibility criteria

Inclusion Criteria:
• Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
• Subjects with HCC who have received standard systemic therapies
• HLA-A \*02
• BCLC stage B or C
• Child-pugh score ≤ 7 ol
• Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be ≤ 1 × 1000 IU/ml
• Have at least one measurable leasion at baseline as per mRECIST and iRECIST
• Life expectancy of 3 months or greater
• The organ function is in good condition.
Exclusion Criteria:
• Subjects with history of another primary cancer within 5 years
• Central nervous system metastasis and clinically significant central nervous system disease
• Previous or current coexistence of hepatic encephalopathy
• Currently present with symptomatic third space fluid accumulation
• Hypertension that is poorly controlled, as determined by researchers (i.e., arterial hypertension that remains uncontrolled despite standard treatment)
• Known history of neurological or mental disorder, including epilepsy or dementia
• Suffering from active autoimmune diseases, or other significant ongoing immune rejection based on pathology and clinical diagnosis
• Prior exposure to any cell therapy such as, but not limited to killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DC), cytotoxic T lymphocytes (CTL), stem cell therapy
• Positive for HCV - RNA test or positive for HAV IgM antibody or positive for HDV IgM antibody; or there is current evidence indicating the presence of HEV infection
• Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine)
• Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation

About Scg Cell Therapy Pte. Ltd.

SCG Cell Therapy Pte. Ltd. is a pioneering clinical trial sponsor dedicated to advancing innovative cell-based therapies for the treatment of various diseases. With a strong focus on research and development, the company leverages cutting-edge technology and scientific expertise to design and conduct rigorous clinical trials that aim to evaluate the safety and efficacy of its therapeutic products. Committed to improving patient outcomes, SCG Cell Therapy collaborates with leading research institutions and healthcare professionals to drive the translation of groundbreaking research into effective treatment options, ultimately contributing to the next generation of regenerative medicine.

Locations

Shanghai, , China

Beijing, Beijing, China

Guangzhou, Guangdong, China

Zhengzhou, Henan, China

Chang Chun, Jilin, China

Shenyang, Liaoning, China

Ji'nan, Shandong, China

People applied

0 patients applied

Timeline

First submit

September 23, 2024

Trial launched

October 25, 2022

Trial updated

September 25, 2024

Estimated completion

Not reported

Discussion 0

A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related Launched by SCG CELL THERAPY PTE. LTD. · Sep 25, 2024

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A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related
Launched by SCG CELL THERAPY PTE. LTD. · Sep 25, 2024