MASCT-I Treatment for Advanced Solid Tumor

A Single Arm, Open, Phase I/II Clinical Study of MASCT-I Treatment for Advanced Solid Tumor

Multiple Target Antigen Stimulating Cell Therapy (MASCT-I) is a new immunotherapy that dendritic cells(DC) was induced from autologous peripheral blood. The DC can then be loaded with antigens and re-infused. In vitro, antigen-pulsed DC can stimulate autologous T-cell proliferation and induction of autologous specific cytotoxic T-cells(CTL)，similarly re-infused. The previous research data showed that MASCT had the modest overall response and less adverse effects for Hepatocellular Carcinoma patients.

The study is aimed to evaluate the safety of MASCT-1 in patients with advanced solid tumors.

Study Overview

• Status: Unknown
• Conditions: Solid Tumors
• Intervention / Treatment: Biological: MASCT-I

Detailed Description

This study is divided into two stages. The first stage is the safety study in small samples, and the second stage is the sample size expansion phase.

40-50 patients with advanced or recurrent solid tumors who had failed after standard treatment will be recruited in this study.

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jiang Xiaodong; Phone Number: +86018961326201; Email: jxdysy1970@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with histologically-confirmed, advanced (unresectable) solid tumors（Lung cancer, colon cancer, prostate cancer, soft tissue sarcoma, other rare tumor） who have progressed on standard therapy.
2. With written informed consent signed voluntarily by patients themselves.
3. The time of between Patients enrollment and the end of other anti-tumors therapies≥1 month.
4. ECOG≤2.
5. At least one measurable lesion as defined by RECIST criteria 1.1 for tumors.
6. Life expectancy ≥6 months.
7. With normal cardiopulmonary function.
8. Patients have adequate organ function as defined by the following criteria:

Hemoglobin (HGB) ≥85g/L Absolute neutrophil count (ANC) ≥1.0×10^9/L White blood cell (WBC) ≥3.0×10^9/L Platelet count ≥80×10^9/L Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) of ≤2.5 upper normal limitation (UNL) or ≤5 UNL in case of liver metastasis Alkaline phosphatase (ALP)≤2.5 UNL Total bilirubin (TBil) of ≤1.5 UNL Blood urea nitrogen (BUN) and Creatinine (Cr) of≤1.5 UNL Albumin (ALB) ≥30g/L

Exclusion Criteria:

1. Pregnant or expecting to pregnant
2. Participated in other clinical trials before screening except of observational study.
3. Refused to provide blood samples.
4. Known allergic history of sodium citrate drugs.
5. Known history of organ transplant, including autologous bone marrow transplantation and peripheral stem cell transplantation.
6. Known active brain metastases
7. The use of immunosuppressive drugs with current or 14 days before enrollment.
8. Active primary immune deficiency.
9. known history of tuberculosis.
10. Active infection, including hepatitis B, hepatitis C virus, or human immunodeficiency virus.
11. Patients with serious infection, hepatopathy, nephropathy, respiratory disease, cardiovascular disease or incontrollable diabetes, etc.
12. Patients have other malignant tumors within 5 years,excluding melanoma and carcinoma in situ of cervix.
13. Clinical signs of heart disease.
14. Treatment with any anti-tumors agent within 28days of first administration of study treatment.
15. The research on the influence of non legal persons, medical or ethical reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: solid tumor; Multiple Target Antigen Stimulating Cell Therapy (MASCT-I)	Biological: MASCT-I; Dendritic cells(DC) loaded with antigens ih day 8, cytotoxic T lymphocytes ( CTL) induced by DC IV day 21-28, every 28 days until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends; Other Names: Multiple Target Antigen Stimulating Cell Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-related adverse events	The incidence of treatment-related adverse events were graded with the use of the National Cancer Institute Common Terminology Criteria for Adverse Events, versio4.0	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	The length of time from enrollment until the time of progression of disease	From enrollment to progression of disease. Estimated about 6 months
Objective Response Rate (ORR)	clinical response of treatment according to RESIST v1.1 criteria	up to 2 years
Disease Control Rate (DCR)	Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) based on RESIST v1.1 criteria.	up to 2 years
Overall Survival (OS)	From enrollment to death of patients	up to 2 years

Other Outcome Measures

Outcome Measure	Time Frame
The relationship between clinical efficacy and antigen specific immune response	up to 2 years

Collaborators and Investigators

• Sponsor: The First People's Hospital of Lianyungang
• Collaborators: Hengrui Yuanzheng Bio-Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: August 3, 2016
• First Posted (Estimate): August 8, 2016

Study Record Updates

• Last Update Posted (Estimate): August 11, 2016
• Last Update Submitted That Met QC Criteria: August 9, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Solid Tumors; MASCT-I
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: LYG1602-01-02