Using IFN-γ and T Cells to Treat 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

This study is testing whether combining a treatment called IFN-γ with T cells can help people with hard-to-treat fluid buildup caused by advanced cancer feel better.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Affiliated Hospital of Jiangnan University (Academic / other)
• Drugs / interventions: CAR T
• Locations: 1 site (Wuxi, Jiangsu)
• Trial ID: NCT05268172 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of combining IFN-γ with T cells in treating patients with refractory malignant pleural effusion and ascites. It employs a multicenter, single-arm, open design to assess how well this combination can improve treatment outcomes for patients with advanced-stage malignancies. The approach leverages the ability of IFN-γ to enhance T cell activity against tumor cells, particularly in cases where standard treatments have failed. The study aims to provide a new therapeutic option for patients suffering from this challenging condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with advanced gastric cancer, colon cancer, lung cancer, lymphoma, or other tumors that have not responded to standard treatments.

Not a fit: Patients with non-malignant pleural effusion or those who have a poor prognosis with an estimated survival of less than three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life and survival rates for patients with refractory malignant pleural effusion and ascites.

How similar studies have performed: While the use of IFN-γ and T cells has shown promise in other studies, this specific combination for refractory malignant pleural effusion and ascites is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Male or female patients: ≥18 years old;
2. 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;
3. 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;
4. ECOG physical condition score: 0-3;
5. Estimated survival ≥3 months;
6. 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%;
7. Signed informed consent;
8. Good compliance, family members agreed to cooperate with survival follow-up.

Exclusion Criteria:

1. Participated in clinical trials of other drugs within four weeks;
2. Patients have a history of other tumors, except cervical carcinoma 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 prior to enrollment);
3. Patients with cardiac clinical symptoms or diseases that are not well controlled, such as NYHA grade 2 or above heart failure, unstable angina pectoris, myocardial infarction within 1 year, and clinically significant ventricular or ventricular arrhythmias requiring treatment or intervention；
4. For female subjects: surgically sterilized, postmenopausal, or have agreed to use a medically approved contraceptive during study treatment and for 6 months after the study treatment period; Serum or urine pregnancy tests must be negative during the 7 days prior to study enrollment and must be non-lactation. Male subjects: patients who are surgically sterilized or who have agreed to use a medically approved contraceptive during and for 6 months after the study treatment period；
5. Patients with active tuberculosis, bacterial or fungal infection (grade ≥2 of NCI-CTC, 3rd edition); Have HIV infection, HBV infection, HCV infection；
6. Those who have a history of psychotropic drug abuse and cannot get rid of it or have mental disorders;
7. The subject has any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism); Subjects with vitiligo or asthma in complete remission during childhood without any intervention as adults could be included; Subjects with asthma requiring medical intervention with bronchodilators were excluded)；
8. According to the judgment of the researcher, there are serious concomitant diseases that endanger the patient's safety or affect the patient's ability to complete the study.

Where this trial is running

Wuxi, Jiangsu

• Affiliated Hospital of Jiangnan University — Wuxi, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: quan liu, doctor — Affiliated Hospital of Jiangnan University
• Study coordinator: liu quan, doctor

Conditions Pleural Effusion, Malignant