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Hepatocellular CarcinomaPhase 2NCT05304481

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

A Phase 2 study testing ATL administration in people with Hepatocellular Carcinoma, run by Lukas Biomedical Inc. at 14 sites in Taiwan.

Recruiting

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

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
ATL administration
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
14 sitesTaiwan
Study dates
14 May 2022to 30 Oct 2028
Phase
Phase 2
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be able to understand and sign the informed consent documents and aware of the investigational nature of the study.
  • Patient is ≥ 20 years old.
  • 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).
  • 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]).
  • 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
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  • Female patient with childbearing potential should be confirmed of not being pregnant at the screening and during the study.
  • Patient must be able to understand and has signed the informed consent documents and been aware of the investigational nature of the study.
  • 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.
  • Hepatic function of Child-Pugh class A
  • ECOG Performance status (ECOG-PS) score ≤ 1
  • Patient's remaining life-time is expected at least more than 3 months.
  • 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
  • Female patient with childbearing potential should be confirmed of not being pregnant or not lactating at the screening and during the study.
  • Patient is willing to comply with protocol-stated requirements, instructions and restrictions.
  • 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.
  • 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).
  • 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.
  • 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
  • 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).

Who cannot join

  • 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)
  • 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
  • Patient who has clinically significant and unstable gastrointestinal, renal, endocrine, pulmonary, or cardiovascular disease judged by the investigator
  • 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
  • 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)
  • Patient with the following medication or treatment should be excluded as the donor:
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  • Systemic corticosteroids within 4 weeks prior to blood collection
  • Immunosuppressive treatment within 4 weeks prior to blood collection
  • Other anti-cancer treatments within 3 months prior to blood collection
  • Attenuated vaccines within 4 weeks prior to blood collection
  • Patient who has participated in other investigational studies and received any investigational therapy within 4 weeks prior to blood collection
  • Patient who has known or suspected hypersensitivity to any ingredient in the product (e.g. kanamycin, streptomycin or albumin, etc.)
  • Patient who has clinically significant and unstable gastrointestinal, renal, endocrine, pulmonary, or cardiovascular disease judged by the investigator
  • 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.
  • Patient who has known or suspected hypersensitivity to any ingredient in the product (e.g. kanamycin, streptomycin or albumin, etc.)
  • Patient with the following medication or treatment should be excluded:
  • Systemic corticosteroids within 4 weeks prior to receiving ATL or are scheduled to do so during the study.
  • Immunosuppressive treatment within 4 weeks prior to receiving ATL or are scheduled to do so during the study.
  • Other anti-cancer treatment within 4 weeks except for curative treatment prior to receiving ATL or are scheduled to do so during the study.
  • Attenuated vaccines within 4 weeks prior to administration or is scheduled to do so during the study
  • Patient who fails to provide blood collection as a self-donor whose blood collection sample fails to generate adequate amount of ATL
  • Patient who is not able to take MRI or CT scan examination
  • Patient who has serious mental, social or psychological factors that may interfere with compliance and assessments of the study in the investigator's opinion
  • Patient who has participated in other investigational studies and received any investigational therapy within 4 weeks prior to the study dosing.

Trial locations and contacts

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

Eric Tang, M.D contact

+886-2-2950-0027

service@lukas-biomedical.com

14 sites in 1 country

Taiwan14 sites, 13 recruiting

  • Hualien Tzu Chi Hospital

    Hualien City, Taiwan, 97002

    Yen-Cheng Chen, MD, 886-3-8561825 ext. 16351, yccmdsurg@tzuchi.com.tw

    Yen-Cheng Chen, MD

    Recruiting

  • E-Da Cancer Treatment Hospital

    Kaohsiung City, 82445

    Cheng-Hao Tseng, M.D., +886-975-106-256, chenhaug@gmail.com

    Cheng-Hao Tseng, M.D.

    Recruiting

  • Cardinal Tien Hospital

    New Taipei City, Taiwan, 23148

    Withdrawn

  • MacKay Memorial Hospital Tamsui Branch

    New Taipei City, Taiwan, 251020

    Jiunn-Chang Lin, MD, PhD, +886-975-836-661, steven4375@gmail.com

    Jiunn-Chang Lin, MD, PhD

    Recruiting

  • Far Estern Memorial Hospital

    New Taipei City, 220216

    Yen-Ling Chiu, M.D., +886-984-098-322, yenling.chiu@gmail.com

    Yen-Ling Chiu, M.D.

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 407219

    Shao-Ciao Luo, M.D., +886-975-358-920, ytppytpp@hotmail.com

    Shao-Ciao Luo, M.D.

    Recruiting

  • Chi Mei Hospital, Liouying

    Tainan, 73657

    Chu-Hsin Chuang, M.D., +886-918-346-987, chuang0105@gmail.com

    Chu-Hsin Chuang, M.D.

    Recruiting

  • National Taiwan University Hospital

    Taipei, Taiwan, 100225

    Kai-Wen Huang, MD, Ph.D., 886-2-23123456 ext. 66144, skywing@ntuh.gov.tw

    Kai-Wen Huang, MD, Ph.D.

    Recruiting

  • Taipei City Hospital, RENAI Branch

    Taipei, Taiwan, 10341

    Chin-Tsung Ting, M.D., +886-979-306-272, DAB74@tpech.gov.tw

    Chin-Tsung Ting, M.D.

    Recruiting

  • Taipei Medical University Hospital

    Taipei, 110301

    Wei-Yu Kao, M.D., +886-960-303-006, 121021@h.tmu.edu.tw

    Wei-Yu Kao, M.D.

    Recruiting

  • Shin Kong Wu Ho Su Memorial Hospital

    Taipei, 111

    Hung-Chih Lai, M.D., +886-984-160-745, ctpetlai@gmail.com

    Hung-Chih Lai, M.D.

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112201

    Hao-Jan Lei, M.D., +886-938-591-173, hjlei@vghtpe.gov.tw

    Hao-Jan Lei, M.D.

    Recruiting

  • Tri-Service General Hospital

    Taipei, 114202

    Hsiu-Lung Fan, M.D., +886-920-817-505, doc20450@gmail.com

    Hsiu-Lung Fan, M.D.

    Recruiting

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 333

    Wei-Chen Lee, M.D., +886-3-328-1200 ext. 3366, weichen@cgmh.org.tw

    Wei-Chen Lee, M.D.

    Recruiting

Other trials in Taiwan

About this study

Official title: 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).

Read the 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.

Being tested
ATL administration
Keywords
Oncology, Hepatocellular Carcinoma, Activated T lymphocytes
Medical subject headings
Carcinoma, Hepatocellular, Neoplasms

What participants receive

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

  • ATL administrationBiological

    Subjects have ATL administration using intravenous infusion

Study groups in NCT05304481
Study groupRoleWhat they receive
TreatmentExperimentalATL administration
Receives: Biological: ATL administration

What is being measured

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

  1. Relapse-free survival rate

    the Relapse-free survival rate of ATL treated HCC patients

    Measured: the baseline (the first dosing) to 12 months later from post-treatment

Secondary outcomes (15)

  1. Relapse-free survival

    the time from baseline (the first dosing) to the first recurrence or death from any cause

    Measured: up to 76 weeks

  2. Overall survival

    the time from baseline (the first dosing) to death from any cause

    Measured: up to 76 weeks

  3. Cancer-specific survival

    the time from baseline (the first dosing) to death resulting from HCC

    Measured: Up to 24 months (estimated according to the average survival time)

  4. Change of biomarkers

    α-fetoprotein (AFP) and Protein Induced by Vitamin K Absence or Antagonist-II (PIVKA-II) level

    Measured: up to 76 weeks

  5. Change in Eastern Cooperative Oncology Group (ECOG) performance status (for evaluation of change in the functional status)

    Assessment with Eastern Cooperative Oncology Group (ECOG) score, in a range from 0 to 5 representing a status from better to worse.

    Measured: up to 76 weeks

  6. Change in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire score (for evaluation of quality of life)

    Assessment with European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 version 3.0, while a higher score means a worse outcome.

    Measured: up to 76 weeks

  7. Number of Participants With Abnormal Laboratory Values

    Number of Participants who encounter abnormal lab test results which are clinically meaningful.

    Measured: up to 76 weeks

  8. Change in body weight from baseline

    body weight

    Measured: up to 76 weeks

  9. AE incidences

    Adverse event incidences

    Measured: up to 76 weeks

  10. Number of Participants With Abnormal physical examination result

    Number of Participants who encounter abnormal physical examination results which are clinically meaningful.

    Measured: up to 76 weeks

  11. Change in ECG examination results

    PR, QRS, QT, QTc, and RR intervals

    Measured: up to 76 weeks

  12. Changes in body temperature

    measurements of vital sign: body temperature

    Measured: up to 76 weeks

  13. Changes in pulse rate

    measurements of vital sign: pulse rate

    Measured: up to 76 weeks

  14. Changes in blood pressures

    measurements of vital sign: blood pressures including both systolic and diastolic pressure.

    Measured: up to 76 weeks

  15. Changes in respiratory rate

    measurements of vital sign: respiratory rate

    Measured: up to 76 weeks

Timeline

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

  1. First posted31 Mar 2022
  2. Study start14 May 2022
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion30 Oct 2028 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
95 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05304481
Sponsor's protocol ID
LUKACTZ20171215
Status last verified
Aug 2026
First submitted
12 Jan 2022
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ATL administration in people with Hepatocellular Carcinoma, run by Lukas Biomedical Inc. at 14 sites in Taiwan.

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 23 inclusion and 24 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 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Taiwan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Eric Tang, M.D (+886-2-2950-0027, service@lukas-biomedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse-free survival rate (time frame: the baseline (the first dosing) to 12 months later from post-treatment). 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 NCT05304481.

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 1 Sep 2026.

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