Hepatocellular CarcinomaPhase 1NCT04368182
AFP Specific T Cell Receptor Transduced T Cells Injection(C-TCR055) in Unresectable Hepatocellular Carcinoma
A Phase 1 study testing Autologous C-TCR055 in people with Hepatocellular Carcinoma, run by Zhejiang University at 1 site in China.
Trial summary
A study that aimed to assess the safety and anti-tumor activity of C-TCR055 injection in unresectable HCC patients 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?
- Autologous C-TCR055
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2020to 30 Nov 2021
- 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
- 1. Able to provide written informed consent. 2. Age 18-70 years old, male or female. 3. Patients must meet the following criteria:
- Histologically confirmed HCC; b. Serum AFP > 200ng/mL; c. Child-Pugh score ≤ 6; d. BCLC stage B and stage C defined by Chinese Liver Cancer Guideline 2017; e. Systemic therapy failed for HCC: those who received standardized systemic treatment for unresectable HCC and subsequently relapsed/progressed, or were intolerable or unwilling to receive treatment. Front-line system treatment should be approved in China (Sorafenib, lenvastinib, platinum-containing chemotherapy, regofinil); f. Previous systemic therapy was discontinued at least 2 weeks before apheresis; g. Local treatment (including surgery, ablation, interventional therapy, local radiotherapy, etc.) must be completed at least 4 weeks before apheresis, and there is no unhealed wound.
- 4. Has at least 1 measurable lesion as defined per RECIST v1.1; 5. HLA-A 02:01 allele positive; 6. Liver AFP expression IHC tests
- ≥20% tumor cells positive, and ≤5% non-tumor tissue positive
- serum AFP ≥400ng/ml, and ≤5% non-tumor tissue positive. 7. ECOG score ≤ 1; 8. Expected survival > 12 weeks 9. Left ventricular ejection fraction (LVEF) ≥ 50% (measured by echocardiography). 10. No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air 11. Laboratory criteria:
- <!-- -->
Show all 13Show fewer
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
- Platelets ≥ 60 x 10^9/L
- Hemoglobin ≥ 90g/L
- Serum total bilirubin ≤ 2 x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase
- Creatinine ≤ 1.5 x ULN 12.If patient has previous HBV infection, patient should receive antivirals treatment following treatment guidelines during study period, and the HBV DNA copies should below the detection limit at screening.
- 13. Female subjects in childbearing age, their serum or urine pregnancy test must be negative, all subjects must agree to take effective contraceptive measures during the trial 14. Agree to abstain from alcohol during the study period 15. No contraindications for apheresis 16. Apheresis was received by laboratory, and passed QC.
Who cannot join
- 1. Have a history of allergy to cellular products. 2. Subject has liver transplantation history. 3. tumor volume was greater than 70% of liver tissue 4. Main portal vein carcinoma thrombus 5. Medium to severe ascites 6. subjects received other anti-tumor systemic therapies which were not recommended in guidelines. Or subjects received immunocheckpoint inhibitors which were discontinued less than 6 weeks or 2 drug half-lives before apheresis.
- 7. Subject has other primary cancer except for the following: A. Non-melanoma cured by excision, such as basal cell skin cancer. B.Cured in situ cancers such as cervical cancer, bladder cancer or breast cancer 8. Significant clinical gastrointestinal bleeding within 4 weeks before treatment. 9. Subjects with bone metastasis or central nervous system metastasis, or with hepatic encephalopathy, epilepsy, cerebrovascular accident and other central nervous system involvement diseases.
- 10. Prior treatment with genetically modified T cell therapy or stem cell therapy.
- 11. Uncontrolled active infection. Preventive antibiotics, antiviral and antifungal are permitted.
- 12. Active hepatitis virus infection. HCV RNA positive. 13. Subjects with syphilis or other acquired, congenital immunodeficiency disorders, including, but not limited to, HIV infected persons, systemic lupus erythematosus, psoriasis, etc.
- 14. Heart insufficiency subjects of Grade III or IV according to NYHA classification criteria.
- 15. Subjects received systemic therapeutic steroid doses (except for the recent or current use of inhaled steroids) or other immunotherapy (such as interleukin-interferon, thymosin, etc.) within 2 weeks before Leukocyte apheresis 16. Subjects received radiotherapy within 6weeks before Leukocyte apheresis 17. Subjects who are pregnant, lactating, or pregnant within 6 months 18. Any other disease that may increase the risk of the subject or interfere with the results of the study.
Trial locations and contacts
1 site in 1 country.
Xueli Bai contact
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
Liang TingBo, MD, PHD, 086-571-87236688, liangtingbo@zju.edu.cn
About this study
Official title: A Study of AFP Specific T Cell Receptor Transduced T Cells Injection in Unresectable Hepatocellular Carcinoma
A study that aimed to assess the safety and anti-tumor activity of C-TCR055 injection in unresectable HCC patients
Read the detailed description
This study plans to enroll 5 patients to assess the safety of C-TCR055. Subjects who meet the eligibility criteria will receive a single dose of C-TCR055 injection, and will be followed up post treatment for safety monitoring. The follow up period will last 12 months.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Autologous C-TCR055
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous C-TCR055Biological
Autologous C-TCR055 administered by intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Autologous C-TCR055 administered by intravenous (IV) infusion Receives: Biological: Autologous C-TCR055 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of C-TCR055
Determine if treatment with C-TCR055 is safe through assessment of adverse events(AEs) and serious adverse
Measured: start treatment to 12 months
Secondary outcomes (3)
ORR
Objective response rate based on RECIST v1.1
Measured: start treatment to 12 months
DCR
Disease control rate based on RECIST v1.1
Measured: 3 months and 6 months
DOR
Duration of remission
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start13 Apr 2020
- Primary completion31 Aug 2020 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368182
- Sponsor's protocol ID
- CISLD7
- Status last verified
- Apr 2020
- First submitted
- 27 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of AFP Specific T Cell Receptor Transduced T Cells Injection in Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04368182
- Acronym / sponsor ID
- CISLD7
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 29 Apr 2020 (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.
A study that aimed to assess the safety and anti-tumor activity of C-TCR055 injection in unresectable HCC patients
Detailed description
This study plans to enroll 5 patients to assess the safety of C-TCR055. Subjects who meet the eligibility criteria will receive a single dose of C-TCR055 injection, and will be followed up post treatment for safety monitoring. The follow up period will last 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Biological: Autologous C-TCR055Autologous C-TCR055 administered by intravenous (IV) infusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1. Able to provide written informed consent. 2. Age 18-70 years old, male or female. 3. Patients must meet the following criteria:
- 4. Has at least 1 measurable lesion as defined per RECIST v1.1; 5. HLA-A 02:01 allele positive; 6. Liver AFP expression IHC tests
- <!-- -->
- 13. Female subjects in childbearing age, their serum or urine pregnancy test must be negative, all subjects must agree to take effective contraceptive measures during the trial 14. Agree to abstain from alcohol during the study period 15. No contraindications for apheresis 16. Apheresis was received by laboratory, and passed QC.
Key exclusion criteria (7 listed)
- 1. Have a history of allergy to cellular products. 2. Subject has liver transplantation history. 3. tumor volume was greater than 70% of liver tissue 4. Main portal vein carcinoma thrombus 5. Medium to severe ascites 6. subjects received other anti-tumor systemic therapies which were not recommended in guidelines. Or subjects received immunocheckpoint inhibitors which were discontinued less than 6 weeks or 2 drug half-lives before apheresis.
- 7. Subject has other primary cancer except for the following: A. Non-melanoma cured by excision, such as basal cell skin cancer. B.Cured in situ cancers such as cervical cancer, bladder cancer or breast cancer 8. Significant clinical gastrointestinal bleeding within 4 weeks before treatment. 9. Subjects with bone metastasis or central nervous system metastasis, or with hepatic encephalopathy, epilepsy, cerebrovascular accident and other central nervous system involvement diseases.
- 10. Prior treatment with genetically modified T cell therapy or stem cell therapy.
- 11. Uncontrolled active infection. Preventive antibiotics, antiviral and antifungal are permitted.
- 12. Active hepatitis virus infection. HCV RNA positive. 13. Subjects with syphilis or other acquired, congenital immunodeficiency disorders, including, but not limited to, HIV infected persons, systemic lupus erythematosus, psoriasis, etc.
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 |
|---|---|---|
| Autologous C-TCR055Autologous C-TCR055 administered by intravenous (IV) infusion | Biological | Treatment group |
Primary outcome
Safety of C-TCR055
Time frame: start treatment to 12 months
Determine if treatment with C-TCR055 is safe through assessment of adverse events(AEs) and serious adverse
3 secondary outcomes
ORR
Time frame: start treatment to 12 months
DCR
Time frame: 3 months and 6 months
DOR
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Hepatocellular Carcinoma
RecruitingPhase 2/3
A Study of VRT106, Combined With Camrelizumab, and Apatinib for Advanced HCC
HCC
Not yet recruitingObservational study
A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.
Hepatocellular Carcinoma (HCC)
Active, not recruitingPhase 2
TheraSphere With Durvalumab and Tremelimumab for HCC
Hepatocellular Carcinoma
RecruitingPhase 1
A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC))
RecruitingPhase 2
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
Solid Tumors
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.
Xueli Bai contact
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 Autologous C-TCR055 in people with Hepatocellular Carcinoma, run by Zhejiang University 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 13 inclusion and 7 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 29 Apr 2020. 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 Tingbo Liang (0571-666128, liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of C-TCR055 (time frame: start treatment to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2020.