- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03971747
AFP Specific T Cell Receptor Transduced T Cells Injection(C-TCR055) in Unresectable Hepatocellular Carcinoma
April 3, 2020 updated by: Cellular Biomedicine Group Ltd.
A Phase 1 Study of AFP Specific T Cell Receptor Transduced T Cells Injection in Unresectable Hepatocellular Carcinoma
A phase 1 study that aimed to assess the safety and anti-tumor activity of C-TCR055 injection in unresectable HCC patients.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This study plans to enroll 9 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 Type
Interventional
Enrollment (Anticipated)
9
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yuhong Zhou, MD, Ph.D
- Phone Number: 86-021-64041990
- Email: zhou.yuhong@zs-hospital.sh.cn
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Fudan University Affiliated Zhongshan Hospital
-
Contact:
- Yuhong Zhou, Ph.D
- Email: zhou.yuhong@zs-hospital.sh.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Able to provide written informed consent.
- Age 18-70 years old, male or female.
Patients must meet the following criteria:
- Histologically confirmed HCC
- Serum AFP >200 ng/mL
- Child-Pugh score ≤6
- BCLC stage B and stage C or stage Ⅱa/Ⅱb and Ⅲa/Ⅲb defined by Chinese Liver Cancer Guideline(2017)
- Clinical confirmed relapse or progression if patient had locoregional therapy previously
- Systemic therapy failed HCC Subject: 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 regimen, regofinil)
- . 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.
- Previous systemic therapy was discontinued at least 2 weeks before apheresis.
- Has at least 1 measurable lesion as defined per RECIST v1.1.
- HLA-A 02:01 allele positive.
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.
- ECOG score ≤ 1.
- Expected survival > 12 weeks
- Left ventricular ejection fraction (LVEF) ≥ 50% (measured by echocardiography).
- No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air.
Laboratory criteria
- Absolute neutrophil count (ANC) ≥ 1.5x10^9/ L
- Platelets≥ 60x10^9/L
- Hemoglobin≥ 90g/L
- Serum total bilirubin ≤ 2 x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5 x ULN
- Creatinine ≤1.5×ULN
- International normalized ratio (INR) or prothrombin time (PT) ≤1.5 x ULN
- 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.
- 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.
- Agree to abstain from alcohol during the study period
- No contraindications for apheresis
- Apheresis was received by laboratory ,and passed QC
Exclusion Criteria:
- Have a history of allergy to cellular products.
- Subject has liver transplantation history.
- tumor volume was greater than 70% of liver tissue
- main portal vein carcinoma thrombus
- Medium to severe ascites.
- subjects received other anti-tumor systemic therapy except standard systemic therapy. Or subjects received immunocheckpoint inhibitors was less than 6 weeks or 2 drug half-lives.
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
- Significant clinical gastrointestinal bleeding within 4 weeks before treatment.
- Subjects with bone metastasis or central nervous system metastasis, or with hepatic encephalopathy, epilepsy, cerebrovascular accident and other central nervous system involvement diseases.
- Prior treatment with genetically modified T cell therapy or stem cell therapy.
- Uncontrolled active infection. Preventive antibiotics, antiviral and antifungal are permitted.
- Active hepatitis virus infection. HCV RNA positive.
- Subjects with syphilis or other acquired, congenital immunodeficiency disorders, including, but not limited to, HIV infected persons, systemic lupus erythematosus, psoriasis, etc.
- Heart insufficiency subjects of Grade III or IV according to NYHA classification criteria.
- 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.
- Subjects received radiotherapy within 6weeks before Leukocyte apheresis
- Subjects who are pregnant, lactating, or pregnant within 6 months
- Any other disease that may increase the risk of the subject or interfere with the results of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: C-TCR055
Autologous C-TCR055 administered by intravenous (IV) infusion
|
Autologous T cells transduced with lentivirus encoding AFP specific TCR gene
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of treatment related adverse events as assessed by CTCAE v4.0[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 events(SAEs) as assessed by CTCAE v4.0
|
start treatment to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DOR
Time Frame: 12 months
|
Duration of remission
|
12 months
|
PFS
Time Frame: 12 months
|
Progression free survival
|
12 months
|
ORR
Time Frame: 3 months and 6 months
|
Overall response rate based on RECIST v1.1
|
3 months and 6 months
|
OS
Time Frame: 6 months and 12 months
|
Overall survival
|
6 months and 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DCR
Time Frame: 3 months and 6 months
|
Disease Control Rate based on RECIST v1.1
|
3 months and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 6, 2019
Primary Completion (Anticipated)
June 1, 2020
Study Completion (Anticipated)
April 1, 2021
Study Registration Dates
First Submitted
May 28, 2019
First Submitted That Met QC Criteria
May 30, 2019
First Posted (Actual)
June 3, 2019
Study Record Updates
Last Update Posted (Actual)
April 7, 2020
Last Update Submitted That Met QC Criteria
April 3, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0421-011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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