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CT011 Autologous CAR-T Cells in Patients With Hepatocellular Carcinoma at Risk of Recurrence After Surgical Resection

RecruitingPhase 1Ages 18 Years - 75 YearsAllCARsgen Therapeutics Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: To be included in the trial, participants must meet all of the following criteria: 1. 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; 2. Age 18-75 years, inclusive, male or female; 3. Initially diagnosed with CNLC stage IIIa HCC with any of the following vascular tumor thrombi and absence of atrial tumor thrombi on preoperative imaging: * Portal vein tumor thrombus (PVTT); * Hepatic vein tumor thrombus (HVTT); * Inferior vena cava tumor thrombus (IVCTT); 4. Has undergone surgical resection: * Pathological evaluation of surgical resection specimen with negative margins; * Preoperative conversion/neoadjuvant therapy and/or postoperative therapy are allowed; 5. 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. 6. Tumor tissue samples positive for GPC3 by immunohistochemistry (IHC) (staining intensity ≥ 1 +, percentage of stained tumor cells ≥ 10%); 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (within 7 days prior to apheresis); 8. Child-Pugh score ≤ 7 points (within 7 days prior to apheresis); 9. Estimated survival \> 12 weeks; 10. Adequate venous access for apheresis; 11. Laboratory test results within 7 days prior to apheresis should meet the following criteria (if the laboratory test results do not meet the following criteria, a repeat test within 1 week is allowed; if the laboratory test results still do not meet the criteria, it will be considered a screening failure): * Hematology (without transfusion, platelet transfusion, colony-stimulating factor and other supportive treatment within 7 days before detection, except recombinant human erythropoietin): neutrophil count (ANC) ≥ 1.5 × 109/L, lymphocyte count (LY) ≥ 0.5 × 109/L, platelet count (PLT) ≥ 75 × 109/L, hemoglobin (Hb) ≥ 9.0 g/dL; The results of hematology within 24 hours before apheresis shall also meet this standard; * Blood chemistry: serum creatinine ≤ 1. 5 × upper limit of normal (ULN), endogenous creatinine clearance ≥ 40 mL/min (using Cockcroft-Gault formula), alanine aminotransferase (ALT) ≤ 5×ULN, aspartate aminotransferase (AST) ≤ 5 × ULN, alkaline phosphatase (ALP) ≤ 5 × ULN, total bilirubin (TBil) ≤ 3 × ULN, serum albumin (ALB) ≥ 28 g/L, and serum lipase and amylase ≤ 2 × ULN; * Prothrombin time (PT) prolongation ≤ 4 s; 12. Female participants of childbearing potential must have a negative serum pregnancy test at screening and agree to remain abstinent or use highly effective and reliable contraception (\< 1% failure rate per year) during the treatment period and for at least 1 year after the last dose of trial treatment, during which time they must not donate eggs: * Women of childbearing potential are defined as women who have not reached post-menarche but have not reached a post-menopausal state (no menses for ≥ 12 consecutive months, with no cause other than menopause) and who have not been permanently infertile due to surgery (removal of ovaries, fallopian tubes, and/or uterus) or other reasons (e.g. M ü llerian agenesis, etc.) as determined by the investigator; * Contraceptive methods with an annual failure rate of \< 1% include: bilateral tubal ligation, male sterilization, approved hormonal contraceptives, hormone-releasing intrauterine devices, copper-containing intrauterine devices; Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation rhythm methods) and withdrawal are not adequate methods of contraception. 13. Male participants who are sexually active with a female of childbearing potential, who have not had a vasectomy, must agree to remain abstinent or to use contraception (e.g., condoms in combination with other contraceptive measures to achieve an annual failure rate of \< 1%, see inclusion criterion # 12) during the treatment period and for 1 year after the last dose of study treatment and refrain from donating sperm during this period. Exclusion Criteria: Participants were not included in the trial if they met any of the following criteria: 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed hepatocellular-cholangiocarcinoma; 2. Intrahepatic recurrence or extrahepatic metastasis, or residual hepatocellular carcinoma detected before apheresis (imaging evidence according to RECIST v1.1); 3. More than 2 years since surgical resection; 4. Pregnant or lactating females; 5. 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; 6. 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; 7. 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; 8. Previous or current hepatic encephalopathy; 9.
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What it tests

  • CT011 CAR-GPC3 T Cells Injection
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Where

15 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Hunan Provincial People's Hospital
Changsha, China
Sichuan Cancer Hospital
Chengdu, China
West China Hospital of Sichuan University
Chengdu, China
Chongqing university ca cer hospital
Chongqing, China
Mengchao hepatobiliary hospital of fujian medical university
Fuzhou, China
Sun Yat-sen University Cancer Center
Guanzhou, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, China

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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