Actively Recruiting

Early Phase 1
Age: 18Years - 75Years
All Genders
NCT06431529

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

Led by JIANG LONGWEI · Updated on 2024-05-28

6

Participants Needed

1

Research Sites

88 weeks

Total Duration

On this page

Sponsors

J

JIANG LONGWEI

Lead Sponsor

N

Nanjing University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 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 refused further chemotherapy with expected survival over 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Patients of childbearing age must use appropriate contraception before and during the study
  • Able to understand the study and provide informed consent
  • Able to follow the study protocol and attend follow-up visits
Not Eligible

You will not qualify if you...

  • Received any form of immunotherapy within the past 3 months
  • Need to use immunosuppressants
  • Received chemotherapy, radiotherapy, or secondary or higher surgery within the past month
  • History of other tumors, except treated cervical cancer in situ, treated squamous cell carcinoma, bladder epithelial tumor (Ta and TIS), or other malignancies treated at least 5 years prior
  • White blood cell count less than 3 x 10^9/L or platelet count less than 80 x 10^9/L
  • Elevated liver enzymes (AST and ALT) or bilirubin above specified limits
  • Creatinine clearance below 60 ml/min
  • Abnormal blood coagulation
  • Active bacterial or fungal infection of grade 2 or higher
  • Positive for hepatitis B or C virus with high viral loads, HIV antibody positive, positive for cytomegalovirus DNA, or positive for syphilis
  • Severe liver, kidney, metabolic, coronary artery, asthma, or cerebrovascular diseases deemed ineligible by the researcher
  • Pregnant or breastfeeding women; women of childbearing age must have a negative pregnancy test within 7 days before enrollment
  • Substance abuse or conditions affecting consent or study participation
  • Allergy to study drugs
  • Participation in other clinical trials within one month before enrollment
  • Inability to undergo mononuclear cell separation or lack of peripheral venous access
  • Any condition that may affect patient safety or compliance
  • Any other reasons deemed unsuitable by the researchers

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Nanjing Jinling Hospital

Nanjing, Jiangsu, China, 210002

Actively Recruiting

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Research Team

J

Jiang Longwei, Master

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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