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

NCT05304481 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: LUKACTZ20171215
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 13

Brief 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. 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).

Conditions

Hepatocellular Carcinoma

Keywords

Oncology; Hepatocellular Carcinoma; Activated T lymphocytes

Outcome Measures

Primary Outcomes (1)

• Relapse-free survival rate

  the Relapse-free survival rate of ATL treated HCC patients

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

Secondary Outcomes (15)

• Relapse-free survival

  up to 76 weeks

• Overall survival

  up to 76 weeks

• Cancer-specific survival

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

• Change of biomarkers

  up to 76 weeks

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

  up to 76 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

ATL administration

Biological: ATL administration

Interventions

ATL administration BIOLOGICAL

Subjects have ATL administration using intravenous infusion

Treatment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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:
• 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 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

Sponsors & Collaborators

• Lukas Biomedical Inc.: lead
• Virginia Contract Research Organization Co., Ltd.: collaborator

Study Sites (13)

Hualien Tzu Chi Hospital

Hualien City, Taiwan, 97002, Taiwan

RECRUITING

Cardinal Tien Hospital

New Taipei City, Taiwan, 23148, Taiwan

NOT YET RECRUITING

National Taiwan University Hospital

Taipei, Taiwan, 100225, Taiwan

RECRUITING

Taipei City Hospital, RENAI Branch

Taipei, Taiwan, 10341, Taiwan

RECRUITING

E-Da Cancer Treatment Hospital

Kaohsiung City, 82445, Taiwan

RECRUITING

Far Estern Memorial Hospital

New Taipei City, 220216, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, 407219, Taiwan

NOT YET RECRUITING

Chi Mei Hospital, Liouying

Tainan, 73657, Taiwan

NOT YET RECRUITING

Taipei Medical University Hospital

Taipei, 110301, Taiwan

RECRUITING

Shin Kong Wu Ho Su Memorial Hospital

Taipei, 111, Taiwan

NOT YET RECRUITING

Taipei Veterans General Hospital

Taipei, 112201, Taiwan

RECRUITING

Tri-Service General Hospital

Taipei, 114202, Taiwan

RECRUITING

Chang Gung Memorial Hospital, Linkou

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Eric Tang, M.D.

  Lukas Biomedical Inc.

  STUDY DIRECTOR

Central Study Contacts

Eric Tang, M.D

CONTACT

+886-2-2950-0027; service@lukas-biomedical.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: March 31, 2022
• Study Start: May 14, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (13)