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

No results posted yet for this study

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05304481 on ClinicalTrials.gov