A Phase I Study of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion

Inclusion Criteria:

1. The patient voluntarily joined the study, signed an informed consent form, and hadgood compliance.
2. Age ≥ 18 years and ≤ 75 years old, regardless of gender.
3. Malignant pleural effusion confirmed by histopathology or cytopathology as moderate orabove and requiring drainage (definition of moderate pleural effusion: pleuraleffusion ≥ 3cm in lying position by B-ultrasound, pleural effusion ≥ 4cm in sittingposition by B-ultrasound, accompanied by clinical symptoms such as chest tightness,shortness of breath, and discomfort).
4. Karnofsky score ≥ 60, or physical fitness score (ECOG PS) ≤ 2.
5. Expected survival time ≥ 3 months.
6. Within 7 days before treatment, the main organ function meets the following criteria:blood routine examination criteria (without blood transfusion within 14 days):neutrophil count ≥ 1.5 × 10 ^ 9 /L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 × 10 ^ 9 /L,White blood cells ≥ 3.0 × 10 ^ 9 /L; Biochemical examination indicators should meet:total bilirubin ≤ 1.5 × ULN, ALT≤2.5 × ULT, AST≤2.5 × ULT, if accompanied by livermetastasis, ALT and AST ≤ 5 × ULN, Serum creatinine (Cr) ≤ 1.5 × ULN or creatinineclearance rate (CCr) ≥ 60ml/min; International normalized ratio (INR) or prothrombintime (PT) ≤ 1.5 × ULN.
7. No intrathoracic drug injection was performed within 1 month before signing theinformed consent form, but diagnostic puncture is not excluded.
8. Women of reproductive age should agree to use contraception (such as intrauterinedevices, birth control pills, or condoms) during the study period and within 6 monthsafter the end of the study; The serum pregnancy test was negative within 7 days beforeenrollment and must be a non lactating patient; Men should agree to use effectivecontraception during the study period and within 6 months after the end of the studyperiod.

Exclusion Criteria:

1. Known allergies to the study drug or its excipient components.
2. The location of pleural effusion is not suitable for drainage or the patient will notbenefit from intrathoracic medication (e.g., severe separation).
3. Have used interferon gene stimulating factor (STING) agonists, TNF drugs (such asTianenfu) for thoracic injection.
4. Have participated in other clinial trials within 4 weeks before signing the informedconsent form.
5. Have a history of immunodeficiency, including a positive test for humanimmunodeficiency virus (HIV) antibodies, or have other acquired or congenitalimmunodeficiency diseases, or have a history of organ transplantation.
6. Uncontrollable systemic infections (viruses, bacteria, fungi), including but notlimited to hepatitis B surface antigen positive and hepatitis B virus DNA > 1000IU/ml, hepatitis C virus (HCV) antibody positive or RNA positive.
7. According to the judgment of the researcher, the patient is not suitable forparticipating in this clinical study for any reason.