Clinical Trials for Liver Cancer Drug Development
Clinical Trials for Liver Cancer Drug Development
In 2018, we obtained orphan drug designation (ODD) from the FDA for liver cancer. In 2021, we received approval for Phase II clinical trials from both the FDA and the TFDA. Additionally, we collaborated with 13 medical centers in Taiwan to conduct multi-center competitive patient enrollment and trials. This is currently the largest clinical trial program in Taiwan's cell therapy industry.
After completing Phase II clinical trials, we plan to apply for conditional drug approval in Taiwan. Upon completing Phase III clinical trials, we will also enjoy a 7-year exclusive market period in the U.S. through the orphan drug designation.
After completing Phase II clinical trials, we plan to apply for conditional drug approval in Taiwan. Upon completing Phase III clinical trials, we will also enjoy a 7-year exclusive market period in the U.S. through the orphan drug designation.
📋Clinical Trial Name
A Phase II clinical trial to evaluate the efficacy and safety of activated T lymphocytes (ATL) in liver cancer patients post-curative treatment.
| Trial Applicant | Lukas Biomedical Inc. |
|---|---|
| Trial Sponsor | Same as the trial applicant |
| Trial Protocol Number | LUKACTZ20171215 |
| Approval Document Number | 1106808507 |
| Approval Registration Date | 19 August 2021 |
| Estimated Trial Period | 1 December 2021 to 31 December 2026 |
Trial Objectives
Primary Objective
To evaluate the efficacy of ATL cell therapy in improving recurrence-free survival rates in liver cancer patients who have undergone curative tumor treatment.
Secondary Objective
To assess the efficacy and safety data of ATL cell therapy in liver cancer patients who have undergone curative tumor treatment
Trial Phase
Phase Ⅱ
Drug Name
Autologous Activated T Lymphocytes (ATL)
Proposed IndicationsLiver cancer post-curative treatment
Trial Hospitals
| Trial Hospitals |
|---|
| Tri-Service General Hospital Outpatient Service Center |
| Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital |
| Taipei Chang Gung Memorial Hospital and Linkou Chang Gung Memorial Hospital |
| Cardinal Tien Hospital |
| Chi Mei Hospital, Liouying |
| Far Eastern Memorial Hospital |
| Shin Kong Wu Ho-Su Memorial Hospital |
| National Taiwan University Hospital |
| E-Da Cancer Hospital |
| Taichung Veterans General Hospital |
| Taipei City Hospital Renai Branch |
| Taipei Veterans General Hospital |
| Taipei Medical University Hospital |
Number of Subjects in the TrialThis program expects to enroll 95 subjects in Taiwan and 95 subjects globally.