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AFP Specific T Cell Receptor Transduced T Cells Injection(C-TCR055) in Unresectable Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368182
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
TingBo Liang, Zhejiang University

Brief Summary:
A study that aimed to assess the safety and anti-tumor activity of C-TCR055 injection in unresectable HCC patients

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Biological: Autologous C-TCR055 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of AFP Specific T Cell Receptor Transduced T Cells Injection in Unresectable Hepatocellular Carcinoma
Actual Study Start Date : April 13, 2020
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : November 30, 2021

Arm Intervention/treatment
Experimental: Treatment group
Autologous C-TCR055 administered by intravenous (IV) infusion
Biological: Autologous C-TCR055
Autologous C-TCR055 administered by intravenous (IV) infusion




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. ORR [ Time Frame: start treatment to 12 months ]
    Objective response rate based on RECIST v1.1

  2. DCR [ Time Frame: 3 months and 6 months ]
    Disease control rate based on RECIST v1.1

  3. DOR [ Time Frame: 12 months ]
    Duration of remission



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Able to provide written informed consent. 2. Age 18-70 years old, male or female. 3. Patients must meet the following criteria:

    a. 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

    1. ≥20% tumor cells positive, and ≤5% non-tumor tissue positive
    2. 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:
    1. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
    2. Platelets ≥ 60 x 10^9/L
    3. Hemoglobin ≥ 90g/L
    4. Serum total bilirubin ≤ 2 x ULN
    5. Aspartate aminotransferase (AST) and alanine aminotransferase
    6. 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.

      Exclusion Criteria:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368182


Contacts
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Contact: Tingbo Liang 0571-666128 liangtingbo@zju.edu.cn
Contact: Xueli Bai shirleybai@zju.edu.cn

Locations
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China, Zhejiang
the First Affiliated Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Liang TingBo, MD, PHD    086-571-87236688    liangtingbo@zju.edu.cn   
Sponsors and Collaborators
Zhejiang University
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Responsible Party: TingBo Liang, Professor, Zhejiang University
ClinicalTrials.gov Identifier: NCT04368182    
Other Study ID Numbers: CISLD7
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases