Trials / Not Yet Recruiting

Not Yet RecruitingNCT07260058

Immune Cell Therapy for Advanced Solid Tumors

Clinical Study on the Safety and Efficacy of Autologous Immune Cell Therapy for Advanced Solid Tumors

Status: Not Yet Recruiting
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 48 (estimated)

Sponsor: Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd. · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

The autologous immune cell induction technology used in this project involves transforming peripheral blood mononuclear cells (PBMC) into autologous DC cells, NK cells, CIK cells and other immune cells through cytokine induction, and then re-administering them to the patients. This therapy utilizes biotechnology to culture the immune cells of cancer patients in vitro and then re-infuse them back into the body, stimulating and enhancing the body's own immune function, killing and inhibiting cancer cells, eliminating small and residual lesions, or achieving the goal of treating cancer by significantly inhibiting the proliferation of residual cancer cells.

Detailed description

This project focuses on the DC autologous immunocyte therapy based on the core technology of screening tumor antigen dominant CTL epitope peptides through independent patent technology. It is a cutting-edge research direction in the field of tumor immunotherapy in recent years. The non-engineered DC cells induced by special induction techniques can effectively overcome the shortcomings of the poor therapeutic effect of engineered gene editing technology on solid tumors, and effectively achieve targeted killing of tumors. The DC-CIK immunocyte therapy adopted in this project utilizes the original discovery of HLA-A molecule-restricted tumor-related antigen CTL epitope peptides to modify DC. On the one hand, through subcutaneous injection in vivo, it induces CD8+ T cells to produce CTL with memory function to play a role in eliminating and monitoring the protein with high expression of the tumor antigen source. On the other hand, it induces CD8+ T cells to produce CTL with memory function in vitro, and directly reinfuses CTL to exert the role of eliminating and monitoring the protein with high expression of the tumor antigen source. In the previous experimental studies, the CTL induced by G22 antigen-loaded DC has shown significant "identification" and targeted "killing" capabilities against various solid tumor cell lines and primary tumor cells isolated from tumor tissues. In animal experiments, it also shows the ability to induce the body to produce a strong immune response against various solid tumors such as breast cancer and non-small cell lung cancer, significantly inhibiting tumor growth, prolonging progression-free survival, and showing no obvious toxic side effects, having a promising application prospect. It has high individualization: customized based on the tumor mutation spectrum of patients, avoiding "off-target" damage to normal tissues. It has high safety: clinical studies have shown that the side effects are mild, mainly including injection site reactions or transient fever 37. Combined treatment potential: it can be used in combination with PD-1 inhibitors, chemotherapy or radiotherapy to enhance efficacy. At present, self-active immune cell therapy based on tumor antigen-specific CTL epitope peptides has achieved significant progress in both research and clinical application in China. Personalized tumor vaccines, targeted immunoregulatory strategies for the tumor microenvironment, and combination treatment strategies are providing new concepts and methods for tumor therapy. In summary, the "Clinical Research on Safety and Effectiveness of Autologous Immune Cell Therapy for Advanced Solid Tumors" is expected to provide a clinical trial basis for the development of safe and effective clinical immunotherapies for patients with solid tumors.

Conditions

Interventions

Type	Name	Description
BIOLOGICAL	Autologous immune Cells	1. Autologous DC-CIK Cells：Dendritic Cells (DC) and Cytokine-Induced Killer (CIK) cells are manufactured ex vivo from the participant's own peripheral blood mononuclear cells (PBMCs). DC cells (\>5x10⁶ cells) are administered via subcutaneous injection. CIK cells (\>5x10⁹ cells) are administered via intravenous infusion. 2. Autologous NK Cells：Natural Killer (NK) cells are manufactured ex vivo from the participant's own peripheral blood mononuclear cells (PBMCs). NK cells (≥3x10⁹ cells) are administered via intravenous infusion.
DRUG	Standard chemotherapy	Investigator's choice of standard chemotherapy regimen(s) appropriate for the participant's specific type of advanced solid tumor (lung, liver, colorectal, or breast cancer), administered according to local clinical practice.

Timeline

Start date: 2025-12-01
Primary completion: 2027-06-30
Completion: 2027-12-31
First posted: 2025-12-02
Last updated: 2025-12-02

Source: ClinicalTrials.gov record NCT07260058. Inclusion in this directory is not an endorsement.