A Study of Tumor Neoantigen-specific T Cells in the Treatment of Advanced Solid Tumors

NCT06431529 | Recruiting Early Phase 1

• 1 other identifier: SWZL20231008
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Tumor, Solid

Keywords

Solid tumor; T cell; neoantigen

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety of tumor neoantigen specific T cells in the treatment of advanced tumor patients

  The adverse events and severe adverse events will be evaluated.

  2 years

Secondary Outcomes (1)

• Evaluate the efficiency of tumor neoantigen specific T cells in the treatment of advanced solid tumor.

  2 years

Study Arms (1)

tumor neoantigen specific T cell

EXPERIMENTAL

Tumor neoantigen specific T cells will be infused intravenously into patients. The number of T cells will be more than 1.0E9.

Biological: tumor neoantigen specific T cell

Interventions

tumor neoantigen specific T cell BIOLOGICAL

Isolate the patient's autologous monocytes, induce and culture them into tumor antigen presenting cells in vitro, and then phagocytose tumor tissue cells obtained from biopsy or surgery to present tumor neoantigens to autologous T cells. The final product For tumor neoantigen specific T cells (NeoT).

tumor neoantigen specific T cell

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• JIANG LONGWEI: lead
• Nanjing University: collaborator

Study Sites (1)

Nanjing Jinling Hospital

Nanjing, Jiangsu, 210002, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jia Shaochang, MD

  Jinling Hospital, China

  STUDY DIRECTOR

Central Study Contacts

Jiang Longwei, Master

CONTACT

+86-02580864524; jianglw2005@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Researcher

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 28, 2024
• Study Start: April 18, 2024
• Primary Completion: March 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)