Efficacy and Safety of Activated T Lymphocytes (ATL) in Hepatocellular Carcinoma

August 28, 2026 updated by: Lukas Biomedical Inc.

A Phase II Study to Evaluate the Efficacy and Safety of Activated T Lymphocytes (ATL) in Hepatocellular Carcinoma (HCC) Patients After Curative Treatment

This is an open-label, single arm, multicenter, Phase II clinical study to investigate the efficacy and safety profiles of autologous ATL administration in HCC patients after curative treatment. Among all the eligible patients, ratio of 7:2:1 for Stage I:II:IIIa of the HCC will be the enrolled strategy of the study to reflect the results of the previous study (Lee, Lee et al. 2015).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Eligible patients with HCC received curative treatment will be given ATL administration in this study. The investigational product ATL revealed great efficacy in previous clinical trials. This study aims to treat eligible patients, who had undergone curative treatment for HCC, with ATL as a preventive immunotherapy and to evaluate the effectiveness on the basis of patients' RFS rate in 12 months. The administration of the subject will be in a staggered manner for the first 3 patients. The 2nd and 3rd subject will not be dosed until the prior subject has taken the 4th dose of investigational products for at least 4 weeks. During the pretreatment period, peripheral blood for manufacturing the individualized ATL agent will be collected from patients at least 28 days before starting treatment. Patients will receive 200 mL of the ATL agent intravenously within 40 to 60 minutes without any premedication. They will be scheduled to receive the ATL 10 times at Weeks 1, 2, 3, 4, 6, 8, 10, 14, 18, and 22. A Data and Safety Monitoring Board (DSMB) will be appointed while 10% of schedule subjects were enrolled and complete 4 times of ATL infusions, the DSMB will convene a meeting to review safety data to date, including AEs and toxicities to indicate whether the study would advance unaltered, amend the protocol, or halt recruitment until a resolution of a specific issue.

Study Type

Interventional

Enrollment (Estimated)

95

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Kaohsiung City, Taiwan, 82445
        • Recruiting
        • E-Da Cancer Treatment Hospital
        • Contact:
        • Principal Investigator:
          • Cheng-Hao Tseng, M.D.
      • New Taipei City, Taiwan, 220216
        • Recruiting
        • Far Estern Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Yen-Ling Chiu, M.D.
      • Taichung, Taiwan, 407219
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:
        • Principal Investigator:
          • Shao-Ciao Luo, M.D.
      • Tainan, Taiwan, 73657
        • Recruiting
        • Chi Mei Hospital, Liouying
        • Contact:
        • Principal Investigator:
          • Chu-Hsin Chuang, M.D.
      • Taipei, Taiwan, 110301
        • Recruiting
        • Taipei Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Wei-Yu Kao, M.D.
      • Taipei, Taiwan, 111
        • Recruiting
        • Shin Kong Wu Ho Su Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Hung-Chih Lai, M.D.
      • Taipei, Taiwan, 112201
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
        • Principal Investigator:
          • Hao-Jan Lei, M.D.
      • Taipei, Taiwan, 114202
        • Recruiting
        • Tri-Service General Hospital
        • Contact:
        • Principal Investigator:
          • Hsiu-Lung Fan, M.D.
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital, Linkou
        • Contact:
        • Principal Investigator:
          • Wei-Chen Lee, M.D.
    • Taiwan
      • Hualien City, Taiwan, Taiwan, 97002
        • Recruiting
        • Hualien Tzu Chi Hospital
        • Principal Investigator:
          • Yen-Cheng Chen, MD
        • Contact:
      • New Taipei City, Taiwan, Taiwan, 23148
        • Withdrawn
        • Cardinal Tien Hospital
      • New Taipei City, Taiwan, Taiwan, 251020
        • Recruiting
        • MacKay Memorial Hospital Tamsui Branch
        • Principal Investigator:
          • Jiunn-Chang Lin, MD, PhD
        • Contact:
      • Taipei, Taiwan, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Principal Investigator:
          • Kai-Wen Huang, MD, Ph.D.
      • Taipei, Taiwan, Taiwan, 10341
        • Recruiting
        • Taipei City Hospital, RENAI Branch
        • Contact:
        • Principal Investigator:
          • Chin-Tsung Ting, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria for Donor

  1. Patients must be able to understand and sign the informed consent documents and aware of the investigational nature of the study.
  2. Patient is ≥ 20 years old.
  3. Patient has been diagnosed as HCC by pathological data or radiological test in the stage of I, II or IIIa according to the American Joint Committee on Cancer staging system (8th Edition).
  4. Patient is scheduled to or has received tumor removal by curative treatments (e.g., surgical operation, percutaneous ethanol injection [PEI], microwave ablation [MWA], or radiofrequency ablation [RFA]).

  5. Patient meets below conditions by blood test, kidney and liver function test:

    White blood cell (WBC) count > 3,000/μL Absolute neutrophil count (ANC) ≥ 1,500/μL Hemoglobin (Hb) ≥ 9.0 g/dL Thrombocyte count > 50,000/μL Blood urea nitrogen (BUN) and serum Creatinine ≤ 1.5× Upper Limit of Normal (ULN) AST and ALT ≤ 5×ULN

  6. Female patient with childbearing potential should be confirmed of not being pregnant at the screening and during the study.

Exclusion Criteria for Donor

  1. Patient with syphilis, human immunodeficiency virus I/II (HIV-I/II), human T-lymphotropic virus I/II (HTLV-I/II), or an increased risk (or has been diagnosed) for human transmissible spongiform encephalopathy (TSE); including Creutzfeldt-Jakob disease (CJD)
  2. Patient with ongoing active hepatitis including acute or active chronic HBV/HCV infection, alcohol-associated hepatitis, and autoimmune hepatitis, etc., according to site-specific diagnostic criteria and laboratory parameters at screening
  3. Patient who has clinically significant and unstable gastrointestinal, renal, endocrine, pulmonary, or cardiovascular disease judged by the investigator
  4. Patient who has disease history of malignancy other than HCC except for curatively treated non-melanoma skin cancer, cervical carcinoma in situ, or superficial bladder tumors within 5 years before participating in this clinical trial
  5. Patient who has medical history of immune deficiency or auto-immune disease (including but not limited to: rheumatoid arthritis , Burger's disease, multiple sclerosis and Type I diabetes)

  6. Patient with the following medication or treatment should be excluded as the donor:

    1. Systemic corticosteroids within 4 weeks prior to blood collection
    2. Immunosuppressive treatment within 4 weeks prior to blood collection
    3. Other anti-cancer treatments within 3 months prior to blood collection
    4. Attenuated vaccines within 4 weeks prior to blood collection
  7. Patient who has participated in other investigational studies and received any investigational therapy within 4 weeks prior to blood collection
  8. Patient who has known or suspected hypersensitivity to any ingredient in the product (e.g. kanamycin, streptomycin or albumin, etc.)

Inclusion Criteria for subject

  1. Patient must be able to understand and has signed the informed consent documents and been aware of the investigational nature of the study.
  2. Patient who has the histopathological or cytological proof (e.g. liver biopsy test) of HCC in the stage of I, II or IIIa. Patient's tumor has been totally removed by curative treatment (surgical operation, PEI, MWA or RFA) in 12 weeks based on the agreement date for written consent and the tumor's removal should be perfectly confirmed by medical imaging (Computed tomography (CT) scan or Magnetic resonance imaging (MRI)) within 4 weeks of first dosing.
  3. Hepatic function of Child-Pugh class A
  4. ECOG Performance status (ECOG-PS) score ≤ 1
  5. Patient's remaining life-time is expected at least more than 3 months.

  6. Patient meets below conditions by blood test, kidney and liver function test:

    WBC count > 3,000/μL ANC ≥ 1,500/μL Hb ≥ 9.0 g/dL Thrombocyte count > 50,000/μL BUN and serum Creatinine ≤ 1.5× ULN AST and ALT ≤ 5×ULN

  7. Female patient with childbearing potential should be confirmed of not being pregnant or not lactating at the screening and during the study.
  8. Patient is willing to comply with protocol-stated requirements, instructions and restrictions.

  9. All male and female patients with child-bearing potential (between puberty and 2 years after menopause) are willing to use at least any one of the appropriate contraception methods shown below, for during and at least 24 weeks after ATL treatment.

    1. Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception).
    2. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
    3. Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject
    4. Combination of any two of the following listed methods: (d.1+d.2 or d.1+d.3, or d.2+d.3):

    d.1Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.

    d.2Placement of an intrauterine device (IUD) or intrauterine system (IUS). d.3Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps).

Exclusion Criteria for Subjects

  1. Patient who has clinically significant and unstable gastrointestinal, renal, endocrine, pulmonary, or cardiovascular disease judged by the investigator
  2. Patient with ongoing active hepatitis including acute or active chronic HBV/HCV infection, alcohol-associated hepatitis, and autoimmune hepatitis, etc., according to site-specific diagnostic criteria and laboratory parameters at screening.
  3. Patient who has known or suspected hypersensitivity to any ingredient in the product (e.g. kanamycin, streptomycin or albumin, etc.)

  4. Patient with the following medication or treatment should be excluded:

    1. Systemic corticosteroids within 4 weeks prior to receiving ATL or are scheduled to do so during the study.
    2. Immunosuppressive treatment within 4 weeks prior to receiving ATL or are scheduled to do so during the study.
    3. Other anti-cancer treatment within 4 weeks except for curative treatment prior to receiving ATL or are scheduled to do so during the study.
    4. Attenuated vaccines within 4 weeks prior to administration or is scheduled to do so during the study
  5. Patient who fails to provide blood collection as a self-donor whose blood collection sample fails to generate adequate amount of ATL
  6. Patient who is not able to take MRI or CT scan examination
  7. Patient who has serious mental, social or psychological factors that may interfere with compliance and assessments of the study in the investigator's opinion
  8. Patient who has participated in other investigational studies and received any investigational therapy within 4 weeks prior to the study dosing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
ATL administration
Biological: ATL administration
Subjects have ATL administration using intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse-free survival rate
Time Frame: the baseline (the first dosing) to 12 months later from post-treatment
the Relapse-free survival rate of ATL treated HCC patients
the baseline (the first dosing) to 12 months later from post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse-free survival
Time Frame: up to 76 weeks
the time from baseline (the first dosing) to the first recurrence or death from any cause
up to 76 weeks
Overall survival
Time Frame: up to 76 weeks
the time from baseline (the first dosing) to death from any cause
up to 76 weeks
Cancer-specific survival
Time Frame: Up to 24 months (estimated according to the average survival time)
the time from baseline (the first dosing) to death resulting from HCC
Up to 24 months (estimated according to the average survival time)
Change of biomarkers
Time Frame: up to 76 weeks
α-fetoprotein (AFP) and Protein Induced by Vitamin K Absence or Antagonist-II (PIVKA-II) level
up to 76 weeks
Change in Eastern Cooperative Oncology Group (ECOG) performance status (for evaluation of change in the functional status)
Time Frame: up to 76 weeks
Assessment with Eastern Cooperative Oncology Group (ECOG) score, in a range from 0 to 5 representing a status from better to worse.
up to 76 weeks
Change in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire score (for evaluation of quality of life)
Time Frame: up to 76 weeks
Assessment with European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 version 3.0, while a higher score means a worse outcome.
up to 76 weeks
Number of Participants With Abnormal Laboratory Values
Time Frame: up to 76 weeks
Number of Participants who encounter abnormal lab test results which are clinically meaningful.
up to 76 weeks
Change in body weight from baseline
Time Frame: up to 76 weeks
body weight
up to 76 weeks
AE incidences
Time Frame: up to 76 weeks
Adverse event incidences
up to 76 weeks
Number of Participants With Abnormal physical examination result
Time Frame: up to 76 weeks
Number of Participants who encounter abnormal physical examination results which are clinically meaningful.
up to 76 weeks
Change in ECG examination results
Time Frame: up to 76 weeks
PR, QRS, QT, QTc, and RR intervals
up to 76 weeks
Changes in body temperature
Time Frame: up to 76 weeks
measurements of vital sign: body temperature
up to 76 weeks
Changes in pulse rate
Time Frame: up to 76 weeks
measurements of vital sign: pulse rate
up to 76 weeks
Changes in blood pressures
Time Frame: up to 76 weeks
measurements of vital sign: blood pressures including both systolic and diastolic pressure.
up to 76 weeks
Changes in respiratory rate
Time Frame: up to 76 weeks
measurements of vital sign: respiratory rate
up to 76 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lukas Biomedical Inc.

Collaborators

Virginia Contract Research Organization Co., Ltd.

Investigators

  • Study Director: Eric Tang, M.D., Lukas Biomedical Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

October 30, 2028

Study Registration Dates

First Submitted

January 12, 2022

First Submitted That Met QC Criteria

March 21, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 28, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUKACTZ20171215

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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