## Protocol Section
### Identification Module
**NCT ID:** NCT06431529

**Acronym:** Neoantigen-T

**Brief Title:** A Study of Tumor Neoantigen-specific T Cells in the Treatment of Advanced Solid Tumors

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

#### Organization Study ID Info
**ID:** SWZL20231008
#### Organization
**Class:** OTHER
**Full Name:** Jinling Hospital, China
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-03-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-18

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Nanjing University

#### Lead Sponsor

**Class:** OTHER

**Name:** JIANG LONGWEI

#### Responsible Party

**Investigator Affiliation:** Jinling Hospital, China

**Investigator Full Name:** JIANG LONGWEI

**Investigator Title:** Associate Researcher

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Tumor, Solid

**Keywords:**

- Solid tumor; T cell; neoantigen

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 6

**Type:** ESTIMATED

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Biological: tumor neoantigen specific T cell

**Label:** tumor neoantigen specific T cell

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 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).

**Name:** tumor neoantigen specific T cell

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** The adverse events and severe adverse events will be evaluated.

**Measure:** Evaluate the safety of tumor neoantigen specific T cells in the treatment of advanced tumor patients

**Time Frame:** 2 years

#### Secondary Outcomes

**Description:** The objective clinical response will be evaluated.

**Measure:** Evaluate the efficiency of tumor neoantigen specific T cells in the treatment of advanced solid tumor.

**Time Frame:** 2 years

### Eligibility Module

**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.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jianglw2005@163.com

**Name:** Jiang Longwei, Master

**Phone:** +86-02580864524

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Nanjing

**Contacts:**

***Contact 1:***

- **Email:** jianglw2005@163.com

- **Name:** Jiang Longwei, Master

- **Phone:** +86-02580864524

- **Role:** CONTACT

***Contact 2:***

- **Name:** Jia Shaochang, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Zen Ke, PhD

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Liu Yuan, PhD

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Jiang Longwei, Master

- **Role:** SUB_INVESTIGATOR

**Country:** China

**Facility:** Nanjing Jinling Hospital

**State:** Jiangsu

**Status:** RECRUITING

**Zip:** 210002

#### Overall Officials

**Official 1:**

**Affiliation:** Jinling Hospital, China

**Name:** Jia Shaochang, MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Meshes

- ID: D000009369

- Term: Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
