TCR-Redirected T Cells Therapy in Patient With HBV Related HCC

NCT03899415 | Unknown Phase 1

• 1 other identifier: LTCR-HCC-3-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1 month after the last infusion

Secondary Outcomes (2)

• Overall Response Rate

  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

  Up to 5 years from the last infusion

Study Arms (1)

TCR-Redirected T Cells

EXPERIMENTAL

HBV antigen specific TCR redirected T cells

Biological: TCR redirected T cells

Interventions

TCR redirected T cells BIOLOGICAL

HBV antigen specific TCR redirected T cell Infusions. Subjects will receive 1x10\^4 - 5x10\^6 TCR redirected T cells by IV infusion.

TCR-Redirected T Cells

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Beijing 302 Hospital: lead
• Lion TCR Pte. Ltd.: collaborator

Study Sites (1)

Beijing 302 Hospital of China

Beijing, Beijing Municipality, 100039, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 34850325 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

• Fusheng Wang, MD

  Beijing 302 Hospital of China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Shi

CONTACT

86-10-63879735; shiming302@sina.com

Study Design

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

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: April 2, 2019
• Study Start: April 20, 2019
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2024
• Last Updated: April 10, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)