MASCT-I Treatment for Advanced Solid Tumor

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02858232
• Other study ID #: LYG1602-01-02
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: July 28, 2016
• Last updated: August 9, 2016
• Start date: August 2016
• Est. completion date: December 2018

Study information

• Verified date: July 2016
• Source: The First People's Hospital of Lianyungang
• Contact: Jiang Xiaodong
• Phone: +86018961326201
• Email: jxdysy1970[@]163.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: December 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Solid Tumors

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The First People's Hospital of Lianyungang	HengRui YuanZheng Bio-Technology Co.,Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The relationship between clinical efficacy and antigen specific immune response		up to 2 years	No
Primary	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	Yes
Secondary	Objective Response Rate (ORR)	clinical response of treatment according to RESIST v1.1 criteria	up to 2 years	No
Secondary	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	No
Secondary	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	No
Secondary	Overall Survival (OS)	From enrollment to death of patients	up to 2 years	No