This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation.
Understand and voluntarily sign the informed consent form prior to participating in any trial-related activities;
Be between 18 and 75 years of age; gender is not restricted;
Diagnosed with hepatocellular carcinoma (HCC) based on histopathological or cytological examination: Patients classified as inoperable Stage IIa, IIb, IIIa, or IIIb according to the Chinese National Liver Cancer (CNLC) staging system, or Stage C according to the Barcelona Clinic Liver Cancer (BCLC) staging system, or Stage B patients who are inoperable or unsuitable for local treatment; Child-Pugh liver function score ≤ 7;
Previous failure of or intolerance to at least two lines of standard systemic therapy;
The subject has undergone major surgery within 2 weeks prior to apheresis, or is expected to undergo major surgery during the trial;
The subject is allergic to any component of the drugs to be used in this study, including but not limited to cyclophosphamide, fludarabine, CAR-T products, or their excipients;
Has not recovered from adverse reactions related to prior surgery or treatment to Grade ≤ 2; exceptions include alopecia, hyperpigmentation, and other conditions deemed by the investigator not to affect the subject's tolerability;
Has a clinically significant central nervous system (CNS) disorder (e.g., epilepsy, severe cerebrovascular stenosis) or other diseases presenting with significant neurological symptoms (including psychiatric disorders);
Single group
Super CAR-T
Biological/VaccineAll participators received lymphoid-depleted preconditioning before Super CAR-T cells infusion. Super CAR-T cells were infused 3 days later.
Dose Limiting Toxicity (DLT)
Determining the DLT of Super CAR-T adoptive Immunotherapy.
Maximum Tolerated Dose (MTD)
Determining the MTD of Super CAR-T adoptive Immunotherapy.
Objective Response Rate(ORR)
ORR defined as the proportion of subjects with a confirmed PR or better best response.
Progression Free Survival(PFS)
PFS defined the time from the subject's treatment to the occurrence of PD or death from any cause, whichever occurred first. If no event (PD or death) occurred, the date of the last response assessment was the censored time for PFS.
Overall Survival (OS)
OS defined time from subject's treatment to death. Participants with no death recorded at the time of statistical analysis were censored at the time of the last follow-up. In cases of loss to follow-up, data were censored at the date of the last contact with the participant.
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Guangzhou FineImmune Biotechnology Co., LTD.
Lead sponsor
Sun Yat-Sen University Cancer Center
Collaborator
