MASCT-I Treatment for Advanced Solid Tumor

NCT02858232 | Unknown Phase 1

• 1 other identifier: LYG1602-01-02
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Solid Tumors

Keywords

MASCT-I; Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Objective Response Rate (ORR)

  up to 2 years

• Disease Control Rate (DCR)

  up to 2 years

• Progression-Free Survival (PFS)

  From enrollment to progression of disease. Estimated about 6 months

• Overall Survival (OS)

  up to 2 years

Other Outcomes (1)

• The relationship between clinical efficacy and antigen specific immune response

  up to 2 years

Study Arms (1)

solid tumor

EXPERIMENTAL

Multiple Target Antigen Stimulating Cell Therapy (MASCT-I)

Biological: MASCT-I

Interventions

MASCT-I BIOLOGICAL

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

Also known as: Multiple Target Antigen Stimulating Cell Therapy

solid tumor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• With written informed consent signed voluntarily by patients themselves.
• The time of between Patients enrollment and the end of other anti-tumors therapies≥1 month.
• ECOG≤2.
• At least one measurable lesion as defined by RECIST criteria 1.1 for tumors.
• Life expectancy ≥6 months.
• With normal cardiopulmonary function.
• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Central Study Contacts

Jiang Xiaodong

CONTACT

+86018961326201; jxdysy1970@163.com

Study Design

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

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 8, 2016
• Study Start: August 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 11, 2016

Record last verified: 2016-07