BridgeMD
New treatment option for Hepatocellular Carcinoma
Official title Ori-C101Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of HCC
ClinicalTrials.gov ID: NCT05652920
What this study is testing
What is Ori-C101?
Ori-C101 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase I, open-label, multi-center study to assess the safety, pharmacokinetics, and preliminary efficacy of GPC3-directed chimeric antigen receptor modified T cells injection (Ori-C101) in Advanced Hepatocellular Carcinoma(HCC).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Confirmed pathologic or radiologic diagnosis of HCC ;
- Tumor tissue GPC3 expression positive by immunohistochemistry(IHC) at the local laboratory (Tumor samples ≤1 years prior to ICF signature are...
- Unresectable stage B (intermediate) or C (advanced) HCC according to the Barcelona Clinic Liver Cancer (BCLC) staging. If stage B, must have...
- Received at least two prior line of systemic therapy (included but not limited to target therapy, immunotherapy or chemotherapy) with radiologic...
- Child-Pugh A or B7, no history of hepatic encephalopathy;
You likely can't join if
- Central nervous system metastatic disease, leptomeningeal disease, or metastatic cord compression;
- Prior bone marrow or organ transplantation;
- Have a history of another primary malignancy within 5 years prior to starting study treatment. Exceptions here are as follows: the disease under...
- Active hepatitis B infection (If Hepatitis B surface antigen [HBsAg] or Hepatitis B core antibody [HBcAb] positive, then HBV-DNA must be \< 20 IU/mL...
- Positive hepatitis C (HCV) RNA, Human Immunodeficiency Virus (HIV) antibody, Cytomegalovirus(CMV) DNA or syphilis serology;
- Have received prior cell-based therapies such as targeted GPC3 therapy, TCR-T therapy, CAR-T therapy;
See the full eligibility criteria
- Confirmed pathologic or radiologic diagnosis of HCC ;
- Tumor tissue GPC3 expression positive by immunohistochemistry(IHC) at the local laboratory (Tumor samples ≤1 years prior to ICF signature are acceptable), if no archived tumor tissue samples, tumor biopsy is required...
- Unresectable stage B (intermediate) or C (advanced) HCC according to the Barcelona Clinic Liver Cancer (BCLC) staging. If stage B, must have progressed after, or not be eligible for, surgical or locoregional therapy;
- Received at least two prior line of systemic therapy (included but not limited to target therapy, immunotherapy or chemotherapy) with radiologic disease progression during or following systemic therapy;
- Child-Pugh A or B7, no history of hepatic encephalopathy;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the time of ICF signature;
- Estimated life expectancy of minimum of 12 weeks;
- Must have at least 1 target lesion
- Central nervous system metastatic disease, leptomeningeal disease, or metastatic cord compression;
- Prior bone marrow or organ transplantation;
- Have a history of another primary malignancy within 5 years prior to starting study treatment. Exceptions here are as follows: the disease under study; adequately treated basal or squamous cell carcinoma of the skin...
- Active hepatitis B infection (If Hepatitis B surface antigen [HBsAg] or Hepatitis B core antibody [HBcAb] positive, then HBV-DNA must be \< 20 IU/mL, and HBsAg-positive patients should have been treated with antiviral...
- Positive hepatitis C (HCV) RNA, Human Immunodeficiency Virus (HIV) antibody, Cytomegalovirus(CMV) DNA or syphilis serology;
- Have received prior cell-based therapies such as targeted GPC3 therapy, TCR-T therapy, CAR-T therapy;
- Inadequate bone marrow reserve or organ function;
- History or current evidence of any condition or disease that could confound the results of the study or, in the opinion of Investigator, is not in the best interest of the patient to participate.
- Pregnant or Breast-feeding women.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Changsha, Hunan, China
- Changchun, Jilin, China
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, China
- Lishui, Zhejiang, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Changsha, Hunan, China; Changchun, Jilin, China; Chengdu, Sichuan, China; Hangzhou, Zhejiang, China; Lishui, Zhejiang, China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.