Efficacy and Safety of Activated T Lymphocytes (ATL) in Hepatocellular Carcinoma
NCT05304481 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95
Last updated 2025-03-06
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
Interventions
- BIOLOGICAL
-
ATL administration
Subjects have ATL administration using intravenous infusion
Sponsors & Collaborators
-
Virginia Contract Research Organization Co., Ltd.
collaborator OTHER -
Lukas Biomedical Inc.
lead INDUSTRY
Principal Investigators
-
Eric Tang, M.D. · Lukas Biomedical Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-14
- Primary Completion
- 2026-12-31
- Completion
- 2027-06-30
- FDA Drug
- Yes
Countries
- Taiwan
Study Locations
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