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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Tumor, Solid
• Intervention / Treatment: Biological: tumor neoantigen specific T cell

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 Type: Interventional
• Enrollment (Estimated): 6
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jiang Longwei, Master; Phone Number: +86-02580864524; Email: jianglw2005@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Recruiting
      • Nanjing Jinling Hospital
      • Contact: Jiang Longwei, Master; Phone Number: +86-02580864524; Email: jianglw2005@163.com
      • Principal Investigator: Jia Shaochang, MD
      • Sub-Investigator: Zen Ke, PhD
      • Sub-Investigator: Liu Yuan, PhD
      • Sub-Investigator: Jiang Longwei, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-75 years old;
2. Patients with solid malignant tumors confirmed by histology or cytology such as ovarian cancer, non-small cell lung cancer or colorectal cancer;
3. Cancer patients who have failed previous standard treatments or who have refused subsequent chemotherapy and whose expected survival time exceeds 3 months;
4. ECOG: 0-2 points;
5. Patients of childbearing age need to take appropriate protective measures (contraceptive measures or other birth control methods) before enrollment and during the experiment;
6. Those who can understand this trial and have signed the informed consent form;
7. Able to follow the research protocol and follow-up procedures

Exclusion Criteria:

1. Those who have received any form of immunotherapy within the past 3 months;
2. Those who need to use immunosuppressants;
3. Those who have received anti-tumor treatment such as tumor chemotherapy, radiotherapy, and secondary and above surgery within the past month;
4. 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) );
5. White blood cell count <3E9/L, platelet count <80E9/L;
6. 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;
7. Creatinine clearance <60ml/min;
8. Abnormal coagulation function;
9. The patient has active bacterial or fungal infection (≥Grade 2 of NCI-CTC, third edition);
10. 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;
11. 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.
12. Women who are pregnant or breastfeeding, and women of childbearing age must have a negative pregnancy test within 7 days before enrollment;
13. Substance abuse, clinical or psychological or social factors that affect informed consent or research implementation;
14. Those who may be allergic to study drugs;
15. Participate in other clinical trials one month before registration;
16. Patients who cannot undergo mononuclear cell separation or whose peripheral venous access cannot be opened;
17. Any uncertain factors that affect patient safety or compliance;
18. Other researchers believe that the subject is not suitable for inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: tumor neoantigen specific T cell; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the efficiency of tumor neoantigen specific T cells in the treatment of advanced solid tumor.	The objective clinical response will be evaluated.	2 years

Collaborators and Investigators

• Sponsor: JIANG LONGWEI
• Collaborators: Nanjing University
• Investigators: Study Director: Jia Shaochang, MD, Jinling Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Solid tumor; T cell; neoantigen
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SWZL20231008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No