NCT05652920 Ori-C101Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of HCC
| NCT ID | NCT05652920 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | OriCell Therapeutics Co., Ltd. |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 105 participants |
| Start Date | 2022-12-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 105 participants in total. It began in 2022-12-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. Confirmed pathologic or radiologic diagnosis of HCC ; 2. 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 for GPC3 expression test; 3. 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; 4. 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; 5. Child-Pugh A or B7, no history of hepatic encephalopathy; 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the time of ICF signature; 7. Estimated life expectancy of minimum of 12 weeks; 8. Must have at least 1 target lesion Exclusion Criteria: 1. Central nervous system metastatic disease, leptomeningeal disease, or metastatic cord compression; 2. Prior bone marrow or organ transplantation; 3. 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; cancer of the cervix in situ; 4. 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 therapies as per the local guidelines); 5. Positive hepatitis C (HCV) RNA, Human Immunodeficiency Virus (HIV) antibody, Cytomegalovirus(CMV) DNA or syphilis serology; 6. Have received prior cell-based therapies such as targeted GPC3 therapy, TCR-T therapy, CAR-T therapy; 7. Inadequate bone marrow reserve or organ function; 8. 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. 9. Pregnant or Breast-feeding women.
Frequently Asked Questions
Who can join the NCT05652920 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05652920 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05652920 currently recruiting?
Yes, NCT05652920 is actively recruiting participants. Visit ClinicalTrials.gov or contact OriCell Therapeutics Co., Ltd. to inquire about joining.
Where is the NCT05652920 trial being conducted?
This trial is being conducted at Beijing, China, Changsha, China, Changchun, China, Chengdu, China and 3 additional locations.
Who is sponsoring the NCT05652920 clinical trial?
NCT05652920 is sponsored by OriCell Therapeutics Co., Ltd.. The trial plans to enroll 105 participants.
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