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Trial Title:
A Study of Tumor Neoantigen-specific T Cells in the Treatment of Advanced Solid Tumors
NCT ID:
NCT06431529
Condition:
Tumor, Solid
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Solid tumor; T cell; neoantigen
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
tumor neoantigen specific T cell
Description:
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).
Arm group label:
tumor neoantigen specific T cell
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Nanjing Jinling Hospital
Address:
City:
Nanjing
Zip:
210002
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiang Longwei, Master
Phone:
+86-02580864524
Email:
jianglw2005@163.com
Investigator:
Last name:
Jia Shaochang, MD
Email:
Principal Investigator
Investigator:
Last name:
Zen Ke, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Liu Yuan, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Jiang Longwei, Master
Email:
Sub-Investigator
Start date:
April 18, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
JIANG LONGWEI
Agency class:
Other
Collaborator:
Agency:
Nanjing University
Agency class:
Other
Source:
Jinling Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06431529
