CT011 Autologous CAR-T Cells in Patients With Hepatocellular Carcinoma at Risk of Recurrence Afte… (NCT06560827) | Clinical Trial Compass
RecruitingPhase 1
CT011 Autologous CAR-T Cells in Patients With Hepatocellular Carcinoma at Risk of Recurrence After Surgical Resection
China30 participantsStarted 2023-10-08
Plain-language summary
A Single-arm, Open-label, Multicenter, Phase Ib Clinical Trial to Evaluate the Safety and Efficacy of CT011 Autologous CAR-T Cells in Patients with Hepatocellular Carcinoma at Risk of Recurrence after Surgical Resection.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Volunteer to participate in the clinical trial; fully understand and are informed of this trial and sign the informed consent form; Willing to follow and able to complete all trial procedures;
✓. Age 18-75 years, inclusive, male or female;
✓. Initially diagnosed with CNLC stage IIIa HCC with any of the following vascular tumor thrombi and absence of atrial tumor thrombi on preoperative imaging:
✓. Has undergone surgical resection:
✓. The participant has recovered from liver resection and postoperative progressive increase in AFP level(including: a. AFP increase of at least 20% in any 3 months after surgery; or b. AFP increase of ≥ 10% in any 2 consecutive tests after surgery) with a potential tendency to recurrence as assessed by the investigator.
✓. Tumor tissue samples positive for GPC3 by immunohistochemistry (IHC) (staining intensity ≥ 1 +, percentage of stained tumor cells ≥ 10%);
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (within 7 days prior to apheresis);
✓. Child-Pugh score ≤ 7 points (within 7 days prior to apheresis);
Exclusion criteria
✕. Known fibrolamellar HCC, sarcomatoid HCC, or mixed hepatocellular-cholangiocarcinoma;
✕. Intrahepatic recurrence or extrahepatic metastasis, or residual hepatocellular carcinoma detected before apheresis (imaging evidence according to RECIST v1.1);
What they're measuring
1
Incidence and severity of treatment-emergent adverse events (TEAE)
Timeframe: Up to 12 months
2
Incidence and severity of treatment-related adverse events (TRAE)
Timeframe: Up to 12 months
3
Incidence and severity of adverse events of special interest (AESI)
✕. Positive test results for any of the following: human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody, hepatitis C virus (HCV) ribonucleic acid (RNA), hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) positive and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] ≥ 1000 IU/mL (HBsAg-positive or HBcAb-positive participants must receive antiviral therapy), cytomegalovirus (CMV) DNA, Epstein-Barr virus (EBV) DNA;
✕. Any uncontrolled active infection, including but not limited to active tuberculosis, infectious diseases requiring systemic treatment, etc.; Patients who use drugs to prevent infection can be enrolled at the discretion of the investigator;
✕. Subjects with clinically significant abnormal thyroid function (free triiodothyronine \[FT3\], free thyroxine \[FT4\] and serum thyroid stimulating hormone \[TSH\] for serum thyroid hormones, and total thyroxine \[TT4\] and total triiodothyronine \[TT3\] for serum thyroid hormones if necessary) judged by the investigator and not suitable for entry into the trial after assessment; Patients with stable thyroid function after treatment can be considered for inclusion;