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HCCPhase 1NCT06560827

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

A Phase 1 study testing CT011 CAR-GPC3 T Cells Injection in people with HCC, run by CARsgen Therapeutics Co., Ltd. at 15 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
HCC
What is being tested?
CT011 CAR-GPC3 T Cells Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
15 sitesChina
Study dates
8 Oct 2023to 30 Jun 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be included in the trial, participants must meet all of the following 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:
  • Portal vein tumor thrombus (PVTT);
  • Hepatic vein tumor thrombus (HVTT);
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  • Inferior vena cava tumor thrombus (IVCTT);
  • Has undergone surgical resection:
  • Pathological evaluation of surgical resection specimen with negative margins;
  • Preoperative conversion/neoadjuvant therapy and/or postoperative therapy are allowed;
  • 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);
  • Estimated survival > 12 weeks;
  • Adequate venous access for apheresis;
  • 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;
  • 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.
  • 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.

Who cannot join

  • Participants were not included in the trial if they met any of the following 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);
  • More than 2 years since surgical resection;
  • Pregnant or lactating females;
  • 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;
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  • 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;
  • Previous or current hepatic encephalopathy;
  • Presence of clinically significant massive abdominal/pleural effusion, defined as: positive signs of pleural/peritoneal effusion on physical examination or pleural/peritoneal effusion requiring intervention (e.g., paracentesis or drug therapy) for control;
  • Toxicities caused by previous treatment have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 ≤ Grade 1, except for alopecia, pigmentation, other laboratory abnormalities that do not affect the tolerability of the participants as judged by the investigator;
  • Received anti-tumor treatment for the disease under study within 2 weeks prior to apheresis, including but not limited to surgery, systemic drug therapy (or within 5 half-lives of the drug, whichever is shorter), radiotherapy, interventional therapy, etc.;
  • Received immunotherapy including anti-PD-1/PD-L1, anti-CTLA-4, or any other investigational therapy within 4 weeks (or within 5 half-lives of the drug, whichever is shorter) prior to apheresis;
  • Previously received any cell therapy (including CAR-T cells, TCR-T cells, TILs, etc.);
  • Received systemic glucocorticoid therapy within 7 days prior to apheresis; Patients with recent or current use of inhaled or topical corticosteroids and physiologic dose replacement therapy may be enrolled;
  • Vaccination with live or live attenuated vaccines within 4 weeks prior to apheresis or planned during the trial;
  • Known active autoimmune disease, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, autoimmune hepatitis, interstitial lung disease, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, multiple sclerosis, glomerulonephritis, etc.; Or other participants who require chronic use of immunosuppressive therapy;
  • Participants with a history of organ transplantation, allogeneic hematopoietic stem cell transplantation or awaiting organ transplantation;
  • Previous allergies to immunotherapy, tocilizumab, cyclophosphamide or fludarabine and other related drugs, previous history of severe allergies, or known allergies to components of CT011 cell infusion preparation (such as albumin or dimethyl sulfoxide, etc.);
  • Presence of central nervous system metastasis or related symptoms, or clinically significant central nervous system disease or abnormal neurological examination results or psychiatric disease;
  • Need for long-term anticoagulation/thrombolysis/antiplatelet therapy (such as warfarin, heparin, rivaroxaban, aspirin, dipyridamole, clopidogrel, etc.); Patients receiving prophylactic anticoagulation to maintain patency of venous access devices may be included in this trial;
  • Major surgical procedure or significant trauma within 4 weeks prior to apheresis, or anticipation of the need for major surgery during the trial;
  • Pre-apheresis oxygen saturation ≤ 95% (under room air, the finger pulse oxygen test is accepted);
  • Any other disease, metabolic disorder, sign, or test result that contraindicates the use of the trial drug, affects the interpretation of the results, or places the participant at high risk of treatment complications, which, as assessed by the investigator, would not be appropriate for participation in the trial, including but not limited to: poorly controlled diabetes mellitus (treated glycosylated hemoglobin [HbA1c] > 8%), poorly controlled hypertension (blood pressure > 160 mmHg/100 mmHg), hypotension requiring vasopressor medication, uncontrolled congestive heart failure (New York Heart Association [NYHA] Class III-IV), Left ventricular ejection fraction [LVEF] < 50%, myocardial infarction within the past 6 months, arrhythmia not well controlled by drug therapy, unstable angina pectoris, or other serious heart disease, pulmonary embolism, chronic obstructive pulmonary disease, interstitial lung disease or clinically significant pulmonary function test abnormality as judged by the investigator; Presence of currently gastrointestinal obstruction or active/unstable gastrointestinal ulcer, gastrointestinal bleeding within the past 3 months or with bleeding risk (e.g., esophageal and gastric varices caused by portal hypertension or bleeding tendency; patients with liver cirrhosis are recommended to undergo additional gastroscopy during the screening period according to the judgment of the investigator to determine the condition of varices); The participant is in a severe inflammatory state overall (e.g., increased neutrophil count and/or C-reactive protein, fever ≥ 38 ℃ unrelated to the underlying disease);
  • Presence of other incurable malignancies within the past 5 years or at the same time, except for appropriately treated cervical carcinoma in situ, skin basal cell carcinoma and other malignancies with very low risk of metastasis/death;
  • Inability or unwillingness of the participant to comply with the requirements of the trial protocol as assessed by the investigator.

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lifeng Zhang contact

86-21-54489928

lifengzhang@carsgen.com

Tianci Su contact

86-21-64501828

tiancisu@carsgen.com

15 sites in 1 country

China15 sites, 15 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing

    hong Zhao

    Recruiting

  • Hunan Provincial People's Hospital

    Changsha

    Pin Lv

    Yong Zhou

    Recruiting

  • Sichuan Cancer Hospital

    Chengdu

    Tongyu Lin

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu

    Tianfu Wen

    Recruiting

  • Chongqing university ca cer hospital

    Chongqing

    Dewei Li

    Yongsheng Li

    Recruiting

  • Mengchao hepatobiliary hospital of fujian medical university

    Fuzhou

    Yongyi Zeng

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guanzhou

    Minshan Chen

    Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou

    xiujun Cai

    Recruiting

  • The second affiliated hospital zhejiang university school of medicine

    Hangzhou

    Sheng Yan

    Recruiting

  • Zhongshan Hospital Fudan University

    Shanghai

    Jia Fan

    Recruiting

  • Liaoning Cancer Hospital

    Shenyang

    Xiangdong Hua

    Recruiting

  • The first hospital of china medical university

    Shenyang

    Jialin Zhang

    Recruiting

  • Tianjin medical university cancer hospital

    Tianjin

    Tianqiang Song

    Recruiting

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Wuhan

    Zhiyong Huang

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Shuijun Zhang

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

This is a single-arm, open-label, multicenter, exploratory phase Ib clinical trial to evaluate the safety, efficacy, and cellular kinetics of CT011 CAR-GPC3 T cells (referred to as CT011) in participants with CNLC stage IIIa, GPC3-positive HCC at risk of recurrence after surgical resection.

Conditions
HCC
Being tested
CT011 CAR-GPC3 T Cells Injection
Keywords
IIIa, GPC3, HCC, CT011

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CT011 CAR-GPC3 T Cells InjectionBiological

    The dose selection for this trial was mainly based on the preliminary safety and efficacy results of CT011-HCC-01 trial in subjects with advanced HCC, in which 3 and 5 subjects in the 2.5 × 108 cell and 5.0 × 108 cell dose groups, respectively, completed a single infusion of CT011. The results showed that the two dose groups of CT011 were generally well tolerated in HCC subjects who failed to standard treatment, with controllable safety, and showed preliminary anti-tumor efficacy.

Study groups in NCT06560827
Study groupRoleWhat they receive
CT011 CAR-GPC3 T Cells InjectionExperimentalThis trial is a single-arm, open-label, exploratory trial, and no statistical hypothesis is made for sample size estimation. It is planned to enroll approximately 30 participants to receive CT011 infusion.
Receives: Biological: CT011 CAR-GPC3 T Cells Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of treatment-emergent adverse events (TEAE)

    According to the two-level classification of System Organ Classification (SOC) and Preferred Term, calculate the number and incidence of each type of AE separately; List and describe the severity of AE and its relationship with experimental treatment.

    Measured: Up to 12 months

  2. Incidence and severity of treatment-related adverse events (TRAE)

    List the AE related to the experimental treatment separately, and calculate the number and incidence of adverse events (TRAEs) related to the experimental treatment.

    Measured: Up to 12 months

  3. Incidence and severity of adverse events of special interest (AESI)

    Regardless of the causal relationship, the following events occurring after CAR-T cell infusion until 12 months after the last infusion are considered AESI: any ≥ grade 3 CRS; ≥ Level 3 HLH; Any ICANS level ≥ 3; Any grade ≥ 2 infusion related reaction (IRR); Any grade 3 or higher allergic reactions, etc. Evaluate the incidence and rate of AESI.

    Measured: Up to 12 months

Secondary outcomes (14)

  1. Recurrence free survival (RFS)

    The time from the first infusion (D0) to the occurrence of intrahepatic recurrence/extrahepatic metastasis or death from any cause, whichever occurs first.

    Measured: Up to 12 months

  2. W24, W48, and W72 RFS rates

    The proportion of participants who survived and did not experience intrahepatic recurrence/extrahepatic metastasis at W24, W48, and W72 after the first infusion (D0).

    Measured: Up to 12 months

  3. Time to recurrence (TTR)

    The time from the first infusion (D0) to the first recording of intrahepatic recurrence and/or extrahepatic metastasis (whichever occurs first).

    Measured: Up to 12 months

  4. Time to intrahepatic recurrence (TT-IHR)

    The time from the first infusion (D0) to the first recording of intrahepatic recurrence.

    Measured: Up to 12 months

  5. Time to extrahepatic spread (TT-EHS)

    The time from the first infusion (D0) to the first recording of extrahepatic spread.

    Measured: Up to 12 months

  6. Postoperative recurrence free survival (RFS2)

    The time from liver resection surgery to the occurrence of intrahepatic recurrence/extrahepatic metastasis or death from any cause, whichever occurs first.

    Measured: Up to 12 months

  7. Overall survival (OS)

    The time from the first infusion (D0) to the participant's death from any cause.

    Measured: Up to 12 months

  8. OS rates of W24, W48, and W72

    the proportion of participants who survived W24, W48, and W72 after the first infusion (D0).

    Measured: Up to 12 months

  9. AFP control rate (ACR) of W24, W48, and W72

    The proportion of participants whose AFP levels reached remission, decrease, and stability at W24, W48, and W72 after the first infusion (D0).

    Measured: Up to 12 months

  10. To evaluate the cellular metabolic kinetics of CT011

    Time to peak expansion (Tmax)

    Measured: Up to 12 months

  11. To evaluate the cellular metabolic kinetics of CT011

    peak expansion (Cmax)

    Measured: Up to 12 months

  12. To evaluate the cellular metabolic kinetics of CT011

    area under the curve (AUC)

    Measured: Up to 12 months

  13. To evaluate the cellular metabolic kinetics of CT011

    continuous survival time (Tlast) of CT011 cells after infusion

    Measured: Up to 12 months

  14. To evaluate the immunogenicity of CT011

    Positive rate of anti-drug antibodies (ADA) after CT011 cell infusion

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2024
  2. Study start8 Oct 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
It is planned to enroll approximately 30 participants to receive CT011 infusion. During the trial, the sample size may be appropriately adjusted as assessed by the sponsor and the investigator.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06560827
Sponsor's protocol ID
CT011-HCC-03
Status last verified
Aug 2024
First submitted
25 Jul 2024
Last updated
19 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CT011 CAR-GPC3 T Cells Injection in people with HCC, run by CARsgen Therapeutics Co., Ltd. at 15 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lifeng Zhang (86-21-54489928, lifengzhang@carsgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of treatment-emergent adverse events (TEAE) (time frame: Up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06560827.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.

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