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

Primary Purpose

Hepatocellular Carcinoma

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

TCR redirected T cells

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
1. Liver function: Child A, ALT < 200 U/L, AST < 200 U/L, Tbil < 17.1umol/L
2. Renal Function: Creatinine clearance ≥ 60ml/minute
3. Cardiac Function: No abnormality in cardiac enzyme and ECG
4. 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

Exclusion Criteria:

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

Sites / Locations

Beijing 302 Hospital of ChinaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TCR-Redirected T Cells

Arm Description

HBV antigen specific TCR redirected T cells

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Response Rate

Tumour assessment will be according to mRECIST v1.1. This is based on percentage of participants with Complete Response (CR) and Partial Response (PR) according to mRECIST v1.1 from baseline.

Overall survival rate

Overall Survival (OS) defined as the time from randomisation until death by any cause. Participants will be followed up for survival follow up for at least five years.

Full Information

NCT ID

NCT03899415

First Posted

January 17, 2019

Last Updated

April 9, 2019

Sponsor

Beijing 302 Hospital

Collaborators

Lion TCR Pte. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03899415

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Recruiting

Study Start Date

April 20, 2019 (Anticipated)

Primary Completion Date

June 1, 2022 (Anticipated)

Study Completion Date

June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beijing 302 Hospital

Collaborators

Lion TCR Pte. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TCR-Redirected T Cells

Arm Type

Experimental

Arm Description

HBV antigen specific TCR redirected T cells

Intervention Type

Biological

Intervention Name(s)

TCR redirected T cells

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety evaluation based in Incidences of adverse events/serious adverse events

Description

Review the safety profile of T-Cell Therapy by assessing adverse/serious adverse events reported.

Time Frame

Up to 1 month after the last infusion

Secondary Outcome Measure Information:

Title

Overall Response Rate

Description

Tumour assessment will be according to mRECIST v1.1. This is based on percentage of participants with Complete Response (CR) and Partial Response (PR) according to mRECIST v1.1 from baseline.

Time Frame

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)

Title

Overall survival rate

Description

Overall Survival (OS) defined as the time from randomisation until death by any cause. Participants will be followed up for survival follow up for at least five years.

Time Frame

Up to 5 years from the last infusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ming Shi

Phone

86-10-63879735

shiming302@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fusheng Wang, MD

Organizational Affiliation

Beijing 302 Hospital of China

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing 302 Hospital of China

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100039

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fusheng Wang, MD

Phone

01066933328

fswang302@163.com

First Name & Middle Initial & Last Name & Degree

Fusheng Wang, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34850325

Citation

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.

Results Reference

derived

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

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