Hepatocellular CarcinomaPhase 1NCT03899415
TCR-Redirected T Cells Therapy in Patient With HBV Related HCC
A Phase 1 study testing TCR redirected T cells in people with Hepatocellular Carcinoma, run by Beijing 302 Hospital at 1 site in China.
Trial summary
This is a single center. single arm, open-label study to determine the safety and clinical benefit of TCR-redirected T cell therapy in patient with HBV related HCC post hepatectomy or radiofrequency ablation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- TCR redirected T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2019to 1 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Expression of the specific human leukocyte antigen (HLA) class I profile
- Hepatocellular carcinoma (HCC) with positive test for hepatitis B virus surface antigen (HBsAg)
- BCLC stage C
- At least 1 month after surgical intervention or 2 weeks after TACE (may include other type of resection/ablation) No major post-operative complication
- Laboratory criteria:
- Liver function: Child A, ALT < 200 U/L, AST < 200 U/L, Tbil < 17.1umol/L
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- Renal Function: Creatinine clearance ≥ 60ml/minute
- Cardiac Function: No abnormality in cardiac enzyme and ECG
- Pulmonary Function (Lung): No abnormality in chest X-ray
- Sexually active subjects must be willing to use an acceptable method of contraception
- Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures
Who cannot join
- Subject experiencing acute infection or gastric bleeding within 30 days
- Mid to late stage cirrhosis, i.e. Child-Pugh Score ≥ 7
- Known history of testing positive for human immunodeficiency virus (HIV)
- Other liver complications, including alcoholic liver disease, non-alcoholic autoimmune liver disease, drug induced liver disease
- Serious systemic conditions, such as mental illness, cerebrovascular disease, coronary heart disease, diabetes, epilepsy
- Women who are pregnant or breast-feeding
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- History of allergic reaction to blood products or investigational products
- History of chronic alcoholism or drug abuse/addiction
- Require systemic medications, such as steroids during the period of study drug administration
- Exposure to any cell therapy such as, but not limited to NK, CIK, DC, CTL, stem cells therapy 6 months prior to study drug administration
- Use of any investigational product (IP) or investigational medical device
- Any condition which could jeopardize the safety of the patient and his/her compliance in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing 302 Hospital of China
Beijing, Beijing Municipality, 100039
Fusheng Wang, MD, 01066933328, fswang302@163.com
Fusheng Wang, MD
About this study
This is a single center. single arm, open-label study to determine the safety and clinical benefit of TCR-redirected T cell therapy in patient with HBV related HCC post hepatectomy or radiofrequency ablation.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- TCR redirected T cells
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCR redirected T cellsBiological
HBV antigen specific TCR redirected T cell Infusions. Subjects will receive 1x10^4 - 5x10^6 TCR redirected T cells by IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| TCR-Redirected T Cells | Experimental | HBV antigen specific TCR redirected T cells Receives: Biological: TCR redirected T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation based in Incidences of adverse events/serious adverse events
Review the safety profile of T-Cell Therapy by assessing adverse/serious adverse events reported.
Measured: Up to 1 month after the last infusion
Secondary outcomes (2)
Overall Response Rate
Tumour assessment will be according to mRECIST v1.1. This is based on percentage of participants with Complete Response (CR) and Partial Response (PR) according to mRECIST v1.1 from baseline.
Measured: Start of Treatment until first documented CR or PR, assessed up to 56 treatment weeks (protocol-defined treatment duration is until disease progression, death, or loss to follow up, whichever came first)
Overall survival rate
Overall Survival (OS) defined as the time from randomisation until death by any cause. Participants will be followed up for survival follow up for at least five years.
Measured: Up to 5 years from the last infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start20 Apr 2019 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lion TCR Pte. Ltd.
- Responsible party
- Sponsor
- Investigators
- Fusheng Wang, MD, Principal investigator, Beijing 302 Hospital of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899415
- Sponsor's protocol ID
- LTCR-HCC-3-1
- Status last verified
- Jan 2019
- First submitted
- 17 Jan 2019
- Last updated
- 10 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meng F, Zhao J, Tan AT, Hu W, Wang SY, Jin J, Wu J, Li Y, Shi L, Fu JL, Yu S, Shen Y, Liu L, Luan J, Shi M, Xie Y, Zhou CB, Wong RW, Lu-En W, Koh S, Bertoletti A, Wang T, Zhang JY, Wang FS. Immunotherapy of HBV-related advanced hepatocellular carcinoma with short-term HBV-specific TCR expressed T cells: results of dose escalation, phase I trial. Hepatol Int. 2021 Dec;15(6):1402-1412. doi: 10.1007/s12072-021-10250-2. Epub 2021 Nov 30.
PubMed 34850325
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TCR-Redirected T Cells Therapy in Patient With HBV Related HCC
- ClinicalTrials.gov ID
- NCT03899415
- Acronym / sponsor ID
- LTCR-HCC-3-1
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Collaborators
- Lion TCR Pte. Ltd.
- Study start
- 20 Apr 2019 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center. single arm, open-label study to determine the safety and clinical benefit of TCR-redirected T cell therapy in patient with HBV related HCC post hepatectomy or radiofrequency ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TCR-Redirected T Cells | Experimental | Biological: TCR redirected T cellsHBV antigen specific TCR redirected T cells |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Expression of the specific human leukocyte antigen (HLA) class I profile
- Hepatocellular carcinoma (HCC) with positive test for hepatitis B virus surface antigen (HBsAg)
- BCLC stage C
- At least 1 month after surgical intervention or 2 weeks after TACE (may include other type of resection/ablation) No major post-operative complication
- Laboratory criteria:
Key exclusion criteria (12 listed)
- Subject experiencing acute infection or gastric bleeding within 30 days
- Mid to late stage cirrhosis, i.e. Child-Pugh Score ≥ 7
- Known history of testing positive for human immunodeficiency virus (HIV)
- Other liver complications, including alcoholic liver disease, non-alcoholic autoimmune liver disease, drug induced liver disease
- Serious systemic conditions, such as mental illness, cerebrovascular disease, coronary heart disease, diabetes, epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCR redirected T cellsHBV antigen specific TCR redirected T cell Infusions. Subjects will receive 1x10^4 - 5x10^6 TCR redirected T cells by IV infusion. | Biological | TCR-Redirected T Cells |
Primary outcome
Safety evaluation based in Incidences of adverse events/serious adverse events
Time frame: Up to 1 month after the last infusion
Review the safety profile of T-Cell Therapy by assessing adverse/serious adverse events reported.
2 secondary outcomes
Overall Response Rate
Time frame: Start of Treatment until first documented CR or PR, assessed up to 56 treatment weeks (protocol-defined treatment duration is until disease progression, death, or loss to follow up, whichever came first)
Overall survival rate
Time frame: Up to 5 years from the last infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Derived from this study: PubMed 34850325Meng F, Zhao J, Tan AT, Hu W, Wang SY, Jin J, Wu J, Li Y, Shi L, Fu JL, Yu S, Shen Y, Liu L, Luan J, Shi M, Xie Y, Zhou CB, Wong RW, Lu-En W, Koh S, Bertoletti A, Wang T, Zhang JY, Wang FS. Immunotherapy of HBV-related advanced hepatocellular carcinoma with short-term HBV-specific TCR expressed T cells: results of dose escalation, phase I trial. Hepatol Int. 2021 Dec;15(6):1402-1412. doi: 10.1007/s12072-021-10250-2. Epub 2021 Nov 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fusheng Wang, MD principal investigator
Beijing 302 Hospital of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TCR redirected T cells in people with Hepatocellular Carcinoma, run by Beijing 302 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Shi (86-10-63879735, shiming302@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety evaluation based in Incidences of adverse events/serious adverse events (time frame: Up to 1 month after the last infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03899415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.