Treatment of malignant pleural effusion with JMKX000197 injection

A Phase I, Open, Multicenter Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion

This study is testing a new injection called JMKX000197 to see if it can safely help people with fluid buildup in the lungs caused by cancer.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jemincare (Industry-sponsored)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT05923515 on ClinicalTrials.gov

What this trial studies

This Phase I clinical trial evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of JMKX000197 injection in patients suffering from malignant pleural effusion. The study aims to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) while exploring dose-limiting toxicities (DLT). It involves multiple centers and includes comprehensive assessments of the drug's metabolic transformation and its effects on patients' conditions.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with confirmed malignant pleural effusion requiring drainage and a Karnofsky score of 60 or higher.

Not a fit: Patients with mild pleural effusion or those with a Karnofsky score below 60 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with malignant pleural effusion, potentially improving their quality of life and survival.

How similar studies have performed: While this approach is novel, similar studies targeting malignant pleural effusion have shown promise in evaluating new treatments.

Eligibility criteria

Inclusion Criteria:

1. The patient voluntarily joined the study, signed an informed consent form, and had good compliance.
2. Age ≥ 18 years and ≤ 75 years old, regardless of gender.
3. Malignant pleural effusion confirmed by histopathology or cytopathology as moderate or above and requiring drainage (definition of moderate pleural effusion: pleural effusion ≥ 3cm in lying position by B-ultrasound, pleural effusion ≥ 4cm in sitting position 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 liver metastasis, ALT and AST ≤ 5 × ULN, Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate (CCr) ≥ 60ml/min; International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN.
7. No intrathoracic drug injection was performed within 1 month before signing the informed consent form, but diagnostic puncture is not excluded.
8. Women of reproductive age should agree to use contraception (such as intrauterine devices, birth control pills, or condoms) during the study period and within 6 months after the end of the study; The serum pregnancy test was negative within 7 days before enrollment and must be a non lactating patient; Men should agree to use effective contraception during the study period and within 6 months after the end of the study period.

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 not benefit from intrathoracic medication (e.g., severe separation).
3. Have used interferon gene stimulating factor (STING) agonists, TNF drugs (such as Tianenfu) for thoracic injection.
4. Have participated in other clinial trials within 4 weeks before signing the informed consent form.
5. Have a history of immunodeficiency, including a positive test for human immunodeficiency virus (HIV) antibodies, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.
6. Uncontrollable systemic infections (viruses, bacteria, fungi), including but not limited to hepatitis B surface antigen positive and hepatitis B virus DNA \> 1000 IU/ml, hepatitis C virus (HCV) antibody positive or RNA positive.
7. According to the judgment of the researcher, the patient is not suitable for participating in this clinical study for any reason.

Where this trial is running

Wuhan, Hubei

• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)

Study contacts

• Principal investigator: Jianying Huang — Zhongnan Hospital of Wuhan University，No. 169, Donghu Road, Wuchang District, Wuhan, Hubei
• Study coordinator: jianping Su

Conditions Malignant Pleural Effusion