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

NCT03971747 | Unknown Phase 1

• 1 other identifier: 0421-011
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

A phase 1 study that aimed to assess the safety and anti-tumor activity of C-TCR055 injection in unresectable HCC patients.

Conditions

Hepatocellular Carcinoma

Keywords

Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment related adverse events as assessed by CTCAE v4.0[Safety of C-TCR055]

  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 Outcomes (4)

• ORR

  3 months and 6 months

• DOR

  12 months

• PFS

  12 months

• OS

  6 months and 12 months

Other Outcomes (1)

• DCR

  3 months and 6 months

Study Arms (1)

C-TCR055

EXPERIMENTAL

Autologous C-TCR055 administered by intravenous (IV) infusion

Biological: AFP Specific T Cell Receptor T Cells

Interventions

AFP Specific T Cell Receptor T Cells BIOLOGICAL

Autologous T cells transduced with lentivirus encoding AFP specific TCR gene

C-TCR055

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai AbelZeta Ltd.: lead
• Shanghai Zhongshan Hospital: collaborator

Study Sites (1)

Fudan University Affiliated ZhongShan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (2)

• Hussein MS, Li Q, Mao R, Peng Y, He Y. TCR T cells overexpressing c-Jun have better functionality with improved tumor infiltration and persistence in hepatocellular carcinoma. Front Immunol. 2023 May 4;14:1114770. doi: 10.3389/fimmu.2023.1114770. eCollection 2023.

  PMID: 37215108 DERIVED

• Luo X, Cui H, Cai L, Zhu W, Yang WC, Patrick M, Zhu S, Huang J, Yao X, Yao Y, He Y, Ji Y. Selection of a Clinical Lead TCR Targeting Alpha-Fetoprotein-Positive Liver Cancer Based on a Balance of Risk and Benefit. Front Immunol. 2020 Apr 27;11:623. doi: 10.3389/fimmu.2020.00623. eCollection 2020.

  PMID: 32425926 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Yuhong Zhou, MD, Ph.D

CONTACT

86-021-64041990; zhou.yuhong@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 3, 2019
• Study Start: August 6, 2019
• Primary Completion: June 1, 2020
• Study Completion: April 1, 2021
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)