NCT05268172

IFN-γ Combined With T Cells in the Treatment of Refractory Malignant Pleural Effusion and Ascites

Single-arm Open Multicenter Study of IFN-γ Combined With T Cells in the Treatment of Refractory Malignant Pleural Effusion Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Affiliated Hospital of Jiangnan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the efficacy of IFN- Y combined with T cells in the treatment of refractory malignant pleural effusion and acties, using a multicenter, single-arm, open design.

Detailed description

Malignant pleural effusion is a common complication of malignant tumor, which usually indicates that the patient has reached the advanced stage, and about 30-40% of the patients are stubborn and refractory cases. The lack of standard therapeutic drugs and protocols in clinical practice seriously affects the anti-tumor treatment effect, quality of life and survival time of patients, and the prognosis is poor. IFN-γ can significantly induce the high expression of the costimulatory molecule ICAM-1 on tumor cells, thereby enhancing the killing of TUMOR cells by T cells. Moreover, IFN-γ can enhance the activity of CAR T cells in the presence of PD-L1-PD-1 pathway, and significantly improve the therapeutic effect of T cells on solid tumors. IFN-γ is an approved clinical treatment with known side effects and well-established symptomatic treatment. Although CIK is not a clinically approved drug, it has been used on a large scale in China with good safety and has entered the medical insurance of some provinces and cities. Tcm is an improved CIK cell and has good safety. Many clinical studies have been carried out, and no serious toxic and side effects have been observed.

Conditions

• Pleural Effusion, Malignant

Interventions

Type	Name	Description
DRUG	IFN-γ and CIK cells, Tcm cells or CAR T cells	A 50ng/ mL IFN-γ solution was prepared, and the required volume of IFN-γ solution was calculated according to the final concentration of 5ng/ mL according to the volume of pleural fluid or ascites of the patient. CIK cells were injected 1.0-2.0×109 on the second day and review three days later.T cells and CAR T cells were selected sequentially according to the re-examination of pleural fluid or ascites.

Timeline

• Start date: 2022-12-20
• Primary completion: 2024-12-30
• Completion: 2025-12-30
• First posted: 2022-03-07
• Last updated: 2024-05-16

Locations

1 site across 1 country: China