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

Who is this study for? Patients with Malignant Pleural Effusion
What treatments are being studied? IFN-? and CIK Cells, Tcm Cells or CAR T Cells
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female patients: ≥18 years old;

• Gastric cancer, colon cancer, lung cancer, lymphoma and other tumors confirmed by histology or cytology. The guidelines recommend entry to clinical trials in accordance with the standard treatment progression recommended by each disease guideline;

• According to iRECIST criteria, the patient should have at least one target lesion with measurable diameter line (tumor lesion CT scan length ≥10 mm, lymph node lesion CT scan short diameter ≥15 mm, scan thickness ≥ 5 mm); Or an unevaluable lesion, including but not limited to pleural effusion, bone metastasis, etc;

• ECOG physical condition score: 0-3;

• Estimated survival ≥3 months;

• Good function of major organs, that is, relevant examination indexes within the first 14 days of randomization meet the following requirements:(1)Routine blood test: 1)Hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); 2)Neutrophil count \> 1.5×109/L; 3)Platelet count ≥ 90×109/L; (2)Biochemical examination: 1)Total bilirubin ≤ 1.5×ULN (upper limit of normal value); 2)Serum alanine aminotransferase (ALT) or AST ≤ 2.5×ULN; ALT or AST ≤ 5×ULN if liver metastasis was present; 3)Endogenous creatinine clearance ≥ 60 mL /min (Cockcroft-Gault formula); (3)Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%;

• Signed informed consent;

• Good compliance, family members agreed to cooperate with survival follow-up.

Locations
Other Locations
China
Affiliated Hospital of Jiangnan University
RECRUITING
Wuxi
Contact Information
Primary
liu quan, doctor
Quanliu.lq@outlook.com
15995299079
Backup
jiang li qing, postgraduate
jjiangliq@163.com
15261479578
Time Frame
Start Date: 2022-12-20
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 40
Treatments
Experimental: IFN- Y combined with T cells
First, IFN-γ was combined with CIK cells. After three failed treatments, the CIK cells were replaced with T cells. After three failed treatments, CART cells were finally replaced.
Related Therapeutic Areas
Sponsors
Collaborators: Hunan Cancer Hospital, West China Hospital, Wuxi People's Hospital, Shenzhen Second People's Hospital, Sichuan University, Zhejiang Provincial People's Hospital
Leads: Affiliated Hospital of Jiangnan University

This content was sourced from clinicaltrials.gov