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Safety and Efficacy Study for MG-7-DC Vaccine in Gastric Cancer Treatment

Primary Purpose

Gastric Cancer

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

DC vaccine

CTL

Sintilimab Injection

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, DC vaccine, CTL, MG-7 antigen, PD-1 monoclonal antibody

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pathologically or cytologically confirmed gastric adenocarcinoma.
Patients should be within age range of ≥18 and ≤80 years old, competent, have signed informed consent and have a life expectancy greater than 6 months.
Failed in previous standard therapy ( surgery, chemotherapy, radiotherapy, and targeted therapy) or recurred from previous therapy, patients must be at least 1 month from their last therapy.
Patients without indications of surgery, radiotherapy or chemotherapy.
Patients who can't tolerate radiotherapy or chemotherapy.
Patients who refuse radiotherapy or chemotherapy.
Have measurable lesion by RECIST 1.1 criteria.
Karnofsky Performance Status (KPS) ≥60.
Patients must be willing to enroll the clinical study, and comply with the study and follow-up procedures.
Adequate organ and bone marrow functions:
1. White Blood Count (WBC) ≥ 3,000/mm3 (3.0×109/L);
2. Neutrophils≥ 1,000/mm3 (1.0×109/L);
3. Platelets (PLT) ≥ 80,000/mm3 (80×109/L);
4. Hemoglobin（Hb）≥ 9 g/dL (90g/L);
5. Serum creatinine ≤ 1.5x the upper limit of normal (ULN) or creatinine clearance (CrCl)≥ 40 mL/min;
6. Bilirubin≤ 1.5x ULN;
7. Aspartate Aminotransferase (AST) ≤ 2.5x ULN or Alanine Aminotransferase (ALT) ≤ 2.5x ULN; patients with liver metastasis must be ≤5x ULN;
8. International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN;
9. Urine protein < 2 +; if urinary protein ≥ 2 +, the 24-hour urine protein quantification must be ≤ 1g.

Exclusion Criteria:

Other diseases that may have influence on this study ( such as active infection, symptomatic myocardial infarction, angina pectoris, arrhythmia, etc.).
Patients who received systemic anti-tumor therapy and local treatment (radiotherapy, ablation and embolization) for gastric cancer within 1 month.
Patients who have active autoimmune diseases and need systemic immunosuppressive therapy.
Life expectancy < 6 months.
Patients with organ allografts.
Women who are pregnant or nursing/breastfeeding
Allergic to allogeneic protein.
Human immunodeficiency virus (HIV) infection, untreated active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU / ml; hepatitis C, defined as HCV-RNA higher than the detection limit of the analytical method).
For any other reasons, the patients are believed not suitable for participation in this study by investigators .

Sites / Locations

The 2nd Hospital of Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

DC vaccine

DC vaccine + CTL (cytotoxic lymphocyte)

DC vaccine + PD-1 monoclonal antibody (Sintilimab Injection)

Arm Description

Vaccine made from autologous dendritic cells loaded with MG-7 antigen.

Cytotoxic lymphocytes are CD3+ T cells co-cultured with DCs.

Sintilimab injection is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) (PR+CR)

The proportion of patients with complete response(CR) or partial response(PR) as measured by RECIST 1.1 criteria.

Disease Control Rate (DCR) (PR+CR+SD)

The proportion of patients with complete response (CR), partial response (PR), or stable disease (SD).

Progression-free Survival (PFS)

The length of time during and after the treatment, that a patient lives with the disease but it does not get worse.

Health-related quality of life (QoL): 36-Item Short Form (SF-36)

Medical Outcomes Study 36-Item Short Form (SF-36)

Secondary Outcome Measures

Objective Response Rate (ORR) (PR+CR)

The proportion of patients with complete response(CR) or partial response(PR) as measured by RECIST 1.1 criteria.

Disease Control Rate (DCR) (PR+CR+SD)

The proportion of patients with complete response (CR), partial response (PR), or stable disease (SD).

Progression-free Survival (PFS)

The length of time during and after the treatment, that a patient lives with the disease but it does not get worse.

Health-related quality of life (QoL): 36-Item Short Form (SF-36)

Medical Outcomes Study 36-Item Short Form (SF-36)

Full Information

NCT ID

NCT04567069

First Posted

September 23, 2020

Last Updated

September 25, 2020

Sponsor

The Second Hospital of Shandong University

Collaborators

Shandong Sunstem Biotechnology Co.,Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04567069

Brief Title

Safety and Efficacy Study for MG-7-DC Vaccine in Gastric Cancer Treatment

Official Title

Phase I/II Study of DC Vaccine Targeting MG-7 Antigen to Treat Gastric Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 2020 (Anticipated)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Second Hospital of Shandong University

Collaborators

Shandong Sunstem Biotechnology Co.,Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The primary purpose of the study is to determine the safety and efficacy of autologous DC vaccine in patients with later stage of gastric cancer. The DC vaccine is gene modified with gastric cancer specific antigen MG-7.

Detailed Description

All eligible patients will receive two cycles of treatment, every 21 days is a treatment cycle. The follow-up time will start from the next day after the end of the second cycle of treatment, and last for 48 ±1 weeks (the follow-up time is 4 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks). During the treatment and follow-up period, if disease progression or intolerable side effects develop, the patient can voluntarily request to be withdrawn from the study, or the investigators can determine that the patient be removed from the study. DC and CTL are immune cells. PD-1 monoclonal antibody is an immune checkpoint inhibitor. According to the relevant experience of similar cells or drugs, some patients may have delayed or early pseudo-tumor progression after receiving immunotherapy, which needs to be judged by investigators. In this study, the screening period is no more than 14 days. After the screening examination and evaluation, the eligible patients will enter the treatment period. The treatment and follow-up are carried out according to the procedure. The follow-up period: tumor imaging evaluation and related clinical indicator evaluation are carried out at the 4th week (± 1 week), the 12th week (± 1 week), the 24th week (± 1 week), the 36th week (± 1 week) and the 48th week (± 1 week) after the treatment. The patients should also complete the corresponding safety inspection and evaluation before leaving the group. During the follow-up period, the patients who do not have disease progression but do leave the group should continue to be evaluated according to the original frequency until the end of the follow-up period or the start of other anti-tumor treatment.

6. Conditions and Keywords

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

Gastric Cancer

Keywords

gastric cancer, DC vaccine, CTL, MG-7 antigen, PD-1 monoclonal antibody

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DC vaccine

Arm Type

Experimental

Arm Description

Vaccine made from autologous dendritic cells loaded with MG-7 antigen.

Arm Title

DC vaccine + CTL (cytotoxic lymphocyte)

Arm Type

Experimental

Arm Description

Cytotoxic lymphocytes are CD3+ T cells co-cultured with DCs.

Arm Title

DC vaccine + PD-1 monoclonal antibody (Sintilimab Injection)

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

DC vaccine

Other Intervention Name(s)

MG-7-DC vaccine, MG-7 antigen-pulsed autologous DC vaccine

Intervention Description

Blood samples will be collected twice, 60-120ml/ time. The 1st collection will occur 5 days before the 1st DC vaccine injection, the 2nd collection will occur 15 days after the 1st injection. Six subcutaneous(ih) injections of DC vaccine will be given at days 1, 8, 15, 21, 28, 35; 1-3×106 cells/time. Injection site: inguinal lymph nodes.

Intervention Type

Biological

Intervention Name(s)

CTL

Intervention Description

Four intravenous (iv) drip injections of CTL will be given at days 7, 9, 27, 29; 1-2×109 cells/time.

Intervention Type

Drug

Intervention Name(s)

Sintilimab Injection

Other Intervention Name(s)

Sintilimab, Tyvyt

Intervention Description

The Sintilimab Injection (3mg/kg) will be administered by intravenous (iv) drip injection at days 0, 20。

Primary Outcome Measure Information:

Title

Objective Response Rate (ORR) (PR+CR)

Description

The proportion of patients with complete response(CR) or partial response(PR) as measured by RECIST 1.1 criteria.

Time Frame

6 months

Title

Disease Control Rate (DCR) (PR+CR+SD)

Description

The proportion of patients with complete response (CR), partial response (PR), or stable disease (SD).

Time Frame

6 months

Title

Progression-free Survival (PFS)

Description

The length of time during and after the treatment, that a patient lives with the disease but it does not get worse.

Time Frame

6 months

Title

Health-related quality of life (QoL): 36-Item Short Form (SF-36)

Description

Medical Outcomes Study 36-Item Short Form (SF-36)

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR) (PR+CR)

Description

The proportion of patients with complete response(CR) or partial response(PR) as measured by RECIST 1.1 criteria.

Time Frame

12 months

Title

Disease Control Rate (DCR) (PR+CR+SD)

Description

The proportion of patients with complete response (CR), partial response (PR), or stable disease (SD).

Time Frame

12 months

Title

Progression-free Survival (PFS)

Description

The length of time during and after the treatment, that a patient lives with the disease but it does not get worse.

Time Frame

12 months

Title

Health-related quality of life (QoL): 36-Item Short Form (SF-36)

Description

Medical Outcomes Study 36-Item Short Form (SF-36)

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pathologically or cytologically confirmed gastric adenocarcinoma. Patients should be within age range of ≥18 and ≤80 years old, competent, have signed informed consent and have a life expectancy greater than 6 months. Failed in previous standard therapy ( surgery, chemotherapy, radiotherapy, and targeted therapy) or recurred from previous therapy, patients must be at least 1 month from their last therapy. Patients without indications of surgery, radiotherapy or chemotherapy. Patients who can't tolerate radiotherapy or chemotherapy. Patients who refuse radiotherapy or chemotherapy. Have measurable lesion by RECIST 1.1 criteria. Karnofsky Performance Status (KPS) ≥60. Patients must be willing to enroll the clinical study, and comply with the study and follow-up procedures. Adequate organ and bone marrow functions: White Blood Count (WBC) ≥ 3,000/mm3 (3.0×109/L); Neutrophils≥ 1,000/mm3 (1.0×109/L); Platelets (PLT) ≥ 80,000/mm3 (80×109/L); Hemoglobin（Hb）≥ 9 g/dL (90g/L); Serum creatinine ≤ 1.5x the upper limit of normal (ULN) or creatinine clearance (CrCl)≥ 40 mL/min; Bilirubin≤ 1.5x ULN; Aspartate Aminotransferase (AST) ≤ 2.5x ULN or Alanine Aminotransferase (ALT) ≤ 2.5x ULN; patients with liver metastasis must be ≤5x ULN; International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; Urine protein < 2 +; if urinary protein ≥ 2 +, the 24-hour urine protein quantification must be ≤ 1g. Exclusion Criteria: Other diseases that may have influence on this study ( such as active infection, symptomatic myocardial infarction, angina pectoris, arrhythmia, etc.). Patients who received systemic anti-tumor therapy and local treatment (radiotherapy, ablation and embolization) for gastric cancer within 1 month. Patients who have active autoimmune diseases and need systemic immunosuppressive therapy. Life expectancy < 6 months. Patients with organ allografts. Women who are pregnant or nursing/breastfeeding Allergic to allogeneic protein. Human immunodeficiency virus (HIV) infection, untreated active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU / ml; hepatitis C, defined as HCV-RNA higher than the detection limit of the analytical method). For any other reasons, the patients are believed not suitable for participation in this study by investigators .

Central Contact Person:

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

Chengyun Zheng, Ph.D

Phone

+86-531-85875502

zhengchengyun186@126.com

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

Chenwei Li, Ph.D

Phone

+86-18653168919

chenwei.li@sunstembio.cn

Facility Information:

Facility Name

The 2nd Hospital of Shandong University

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250033

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chengyun Zheng, Ph.D.

Phone

+86-531-85875502

zhengchengyun186@126.com

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study for MG-7-DC Vaccine in Gastric Cancer Treatment

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