A Study to Evaluate CG-102-12C in Glypican-3 (GPC3) Positive Advanced Hepatocellular Carcinoma (HCC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang University
About this trial
This study is a single-centre, single-arm, open-label, dose-escalation exploratory study with single-dose administration. Its objective is to evaluate the safety, tolerability, dose, anti-tumor efficacy, and pharmacokinetic characteristics of CG-102-12C in the participants with GPC3-positive advanced hepatocellular carcinoma who previously received adequate but uneffective systemic standard treatments.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. The study participant has fully understood the potential risks and benefits of participating in this study and has signed the informed consent form.
2. Aged 18-75 years (inclusive of 18 and 75 years old).
3. Patients with advanced hepatocellular carcinoma (HCC) confirmed by histopathological or cytological examination to be GPC3-positive (advanced HCC is defined as Barcelona Clinic Liver Cancer (BCLC) stage C or stage B that is unsuitable for or has progressed after local treatment, including ablation therapy, interventional therapy, and radiotherapy). Patients must have previously received systemic standard treatment and experienced treatment failure or intolerance (systemic treatments include, but are not limited to, chemotherapy and molecular targeted therapy). Treatment failure is defined as disease progression during or after the most recent treatment.
4. Immunohistochemical analysis of tumor tissue samples must show GPC3 positivity (defined as >25% of pathological specimens with IHC-detected GPC3-positive cells and staining intensity ≥1+). Preferably ,target lesion specimens will be used, including freshly obtained tumor pathology samples or archived tumor pathology samples deemed acceptable by the investigator.
Disqualifiers
1. History of a second primary malignancy is permitted, unless the patient has undergone potentially curative treatment and has been free of the disease for 5 years.
2. Prior treatment with CAR-T or TCR-T cell therapy targeting any antigen or therapeutic cancer vaccines; or prior treatment with any therapy targeting GPC3.
3. Prior to apheresis, the patient has received the following antitumor therapies: Cytotoxic therapy within 14 days; Small molecule targeted therapy, epigenetic therapy, or experimental drug therapy within 14 days or at least 5 half-lives (whichever is longer), or treatment with invasive experimental medical devices; Monoclonal antibody therapy within 21 days; Immunomodulatory therapy within 7 days; Radiotherapy within 14 days.
4. Toxicities from prior antitumor therapies have not recovered to ≤ Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 5.0), except for alopecia, Grade 2 peripheral neuropathy, and hypothyroidism controlled by hormone replacement therapy.
Trial design
Design model
Single group
Treatments tested in this trial
CG-102-12C
Biological/VaccineChimeric Antigen Receptor Autologous T-cell
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose limiting toxicity (DLT)
Describe the adverse events of limiting further increases in the dose of CG-102-12C
Time frame
Within 28 days of CG-102-12C infusion2
Treatment-emergent adverse events (TEAEs)
Describe adverse events (AEs) and serious adverse events (SAEs) that are related to the study treatment during the treatment period.
Time frame
Within 24 months after the treatmentSecondary outcomes
1
Objective response rate (ORR)
Objective response rate by RECIST 1.1.
Time frame
From treatment of the first subject to completion of follow-up of the last subject (up to 5 years)2
Disease control rate (DCR)
The proportion of patients whose disease is controlled, which includes those who achieve a complete response (CR), partial response (PR), or stable disease (SD), out of the total number of evaluable patients.
Time frame
within 1 year after the last subject was treated3
Duration of remission (DOR)
Duration of response by RECIST 1.1
Time frame
From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)4
Time to remission (TTR)
Time to remission by RECIST 1.1
Time frame
From enrollment of the first subject to completion of follow-up of the last subject (up to 3 years)Other outcomes
1
Immune cell subsets endpoint
The proportion of peripheral blood immune cells at different sampling points before and after the reinfusion of CG-102-12C injection.
Time frame
Within 28 days of CG-102-12C infusion2
Cytokine / inflammation related protein endpoint
IL-2, IL-2 and IL-2 before and after reinfusion of CG-102-12C injection The concentration levels of IL-6, IL-15, IL-21, IFN-γ, TNF α, C-reactive protein, ferritin.
Time frame
Within 28 days of CG-102-12C infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhejiang University
Lead sponsor
Cells & Genes Biotech
Collaborator
Source ClinicalTrials.gov