Actively Recruiting
Efficacy and Safety of Activated T Lymphocytes (ATL) in Hepatocellular Carcinoma
Led by Lukas Biomedical Inc. · Updated on 2025-03-06
95
Participants Needed
13
Research Sites
267 weeks
Total Duration
On this page
Sponsors
L
Lukas Biomedical Inc.
Lead Sponsor
V
Virginia Contract Research Organization Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Efficacy and Safety of Activated T Lymphocytes (ATL) in Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent
- 20 years or older
- Diagnosed with HCC stage I, II, or IIIa by pathology or imaging
- Scheduled to receive or have received curative tumor removal (surgery, PEI, MWA, or RFA)
- Blood and organ function within specified limits: WBC > 3,000/μL, ANC ≥ 1,500/μL, Hb ≥ 9.0 g/dL, platelets > 50,000/μL, BUN and creatinine ≤ 1.5× ULN, AST and ALT ≤ 5× ULN
- Female patients with childbearing potential confirmed not pregnant at screening and during study
- Histological or cytological proof of HCC with total tumor removal confirmed by CT or MRI within 4 weeks before first dosing
- Hepatic function Child-Pugh class A
- ECOG performance status ≤ 1
- Expected life expectancy over 3 months
- Willing to comply with study requirements
- Use appropriate contraception during and for at least 24 weeks after treatment if of childbearing potential
You will not qualify if you...
- Infection with syphilis, HIV I/II, HTLV I/II, or risk of transmissible spongiform encephalopathy
- Active hepatitis including acute or chronic HBV/HCV, alcohol-associated or autoimmune hepatitis
- Clinically significant unstable gastrointestinal, renal, endocrine, pulmonary, or cardiovascular disease
- History of malignancy other than HCC except certain curatively treated cancers within 5 years
- Immune deficiency or autoimmune diseases such as rheumatoid arthritis, Burger's disease, multiple sclerosis, or Type I diabetes
- Use of systemic corticosteroids, immunosuppressants, anti-cancer treatments, or attenuated vaccines within specified timeframes before blood collection or treatment
- Participation in other investigational studies or therapies within 4 weeks prior to blood collection or dosing
- Known or suspected hypersensitivity to product ingredients
- Failure to provide adequate blood sample for ATL production
- Inability to undergo MRI or CT scans
- Serious mental, social, or psychological conditions interfering with study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Hualien Tzu Chi Hospital
Hualien City, Taiwan, Taiwan, 97002
Actively Recruiting
2
Cardinal Tien Hospital
New Taipei City, Taiwan, Taiwan, 23148
Not Yet Recruiting
3
National Taiwan University Hospital
Taipei, Taiwan, Taiwan, 100225
Actively Recruiting
4
Taipei City Hospital, RENAI Branch
Taipei, Taiwan, Taiwan, 10341
Actively Recruiting
5
E-Da Cancer Treatment Hospital
Kaohsiung City, Taiwan, 82445
Actively Recruiting
6
Far Estern Memorial Hospital
New Taipei City, Taiwan, 220216
Actively Recruiting
7
Taichung Veterans General Hospital
Taichung, Taiwan, 407219
Not Yet Recruiting
8
Chi Mei Hospital, Liouying
Tainan, Taiwan, 73657
Not Yet Recruiting
9
Taipei Medical University Hospital
Taipei, Taiwan, 110301
Actively Recruiting
10
Shin Kong Wu Ho Su Memorial Hospital
Taipei, Taiwan, 111
Not Yet Recruiting
11
Taipei Veterans General Hospital
Taipei, Taiwan, 112201
Actively Recruiting
12
Tri-Service General Hospital
Taipei, Taiwan, 114202
Actively Recruiting
13
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan, 333
Actively Recruiting
Research Team
E
Eric Tang, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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