Exploratory Clinical Study of Tumor Neoantigen-specific T Cells in the Treatment of Advanced Solid Tumors
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Evaluate the safety of tumor neoantigen specific T cells in the treatment of advanced tumor patients
Study Overview
Brief Summary
The goal of this clinical trial is to learn if tumor neoantigen-specific T cells can treat patients with advanced solid tumors. The main questions it aims to answer are:
Evaluate the safety of intravenous infusion of tumor neoantigen-specific T cells in the treatment of advanced solid tumors such as ovarian cancer, non-small cell lung cancer, and colorectal cancer.
To evaluate the effectiveness of intravenous infusion of tumor neoantigen-specific T cells in the treatment of advanced solid tumors such as ovarian cancer, non-small cell lung cancer, and colorectal cancer and to study its immunological properties in patients.
Detailed Description
In this open, single-armed study, selected patients with advanced solid tumor confirmed by Histopathology will be received tumor neoantigen specific T cells treatment. First, their tumor specimen will be collected from surgery or puncture，then their PBMC will be separated by blood cell separator. This cells will be cultured and selected in GMP laboratory to make tumor neoantigen specific T cells. The tumor neoantigen specific T cells will be infused intravenous into patients.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-75 years old;
- •Patients with solid malignant tumors confirmed by histology or cytology such as ovarian cancer, non-small cell lung cancer or colorectal cancer;
- •Cancer patients who have failed previous standard treatments or who have refused subsequent chemotherapy and whose expected survival time exceeds 3 months;
- •ECOG: 0-2 points;
- •Patients of childbearing age need to take appropriate protective measures (contraceptive measures or other birth control methods) before enrollment and during the experiment;
- •Those who can understand this trial and have signed the informed consent form;
- •Able to follow the research protocol and follow-up procedures
Exclusion Criteria
- •Those who have received any form of immunotherapy within the past 3 months;
- •Those who need to use immunosuppressants;
- •Those who have received anti-tumor treatment such as tumor chemotherapy, radiotherapy, and secondary and above surgery within the past month;
- •Those who have a history of other tumors in the past, unless it is cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial tumor (Ta and TIS), or other malignant tumors that have received radical treatment (at least 5 years before enrollment) );
- •White blood cell count <3E9/L, platelet count <80E9/L;
- •AST and ALT>3×the upper limit of normal (ULN), total bilirubin>2×ULN, and AST and ALT>6×ULN in patients with liver metastasis;
- •Creatinine clearance <60ml/min;
- •Abnormal coagulation function;
- •The patient has active bacterial or fungal infection (≥Grade 2 of NCI-CTC, third edition);
- •Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) is positive and the peripheral blood hepatitis B virus (HBV) DNA detection value is >100 IU/mL; hepatitis C virus (HCV) antibody is positive and the peripheral blood hepatitis C Those who are positive for hepatitis virus (HCV) RNA; those who are positive for human immunodeficiency virus (HIV) antibodies; those who are positive for cytomegalovirus (CMV) DNA; those who are positive for syphilis;
- •Diseases judged by the researcher to be ineligible for inclusion: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment, uncontrollable coronary artery disease or asthma, and uncontrollable cerebrovascular disease.
- •Women who are pregnant or breastfeeding, and women of childbearing age must have a negative pregnancy test within 7 days before enrollment;
- •Substance abuse, clinical or psychological or social factors that affect informed consent or research implementation;
- •Those who may be allergic to study drugs;
- •Participate in other clinical trials one month before registration;
- •Patients who cannot undergo mononuclear cell separation or whose peripheral venous access cannot be opened;
- •Any uncertain factors that affect patient safety or compliance;
- •Other researchers believe that the subject is not suitable for inclusion.
Outcomes
Primary Outcomes
Evaluate the safety of tumor neoantigen specific T cells in the treatment of advanced tumor patients
Time Frame: 2 years
The adverse events and severe adverse events will be evaluated.
Secondary Outcomes
- Evaluate the efficiency of tumor neoantigen specific T cells in the treatment of advanced solid tumor.(2 years)
Investigators
JIANG LONGWEI
Associate Researcher
Jinling Hospital, China