Clinical Study of QH104 Cell Injection for the Treatment of Meningeal Metastases of B7H3+ Solid Tumors

Inclusion Criteria:

1. Age ≥18 years;

2. Have a histologically or cytologically confirmed solid malignant tumor with positiveB7H3 expression;

3. ECOG ≤ 2 or KPS ≥ 60;

4. Life expectancy ≥ 8 weeks as assessed by the investigator;

5. Meningeal metastases (or with brain parenchymal metastases) from any solidmalignancy that is refractory to standard treatment or for which no standardtreatment is available and positive cerebrospinal fluid (CSF) cytology;

6. Substantially normal bone marrow reserve function and normal hepatic and renalfunction (laboratory tests are required to be satisfied prior to first treatmentwith QH104 Cell Injection): White blood cell count (WBC) ≥ 3 x 109/L; Lymphocyte count (LY) ≥ 0.8 x 109/L;Hemoglobin (Hb) ≥ 90 g/L; Platelet (PLT) ≥90×109/L; Albumin transaminase (ALT) &albumin transaminase (AST) < 1.5 x ULN; Serum creatinine (Cr) < 1.5 x ULN; Totalbilirubin < 1.5 x ULN; PT & PTT ≤ 1.25 × ULN.

7. Pregnancy test should be negative for women of childbearing potential and both menand women agree to use effective contraception during treatment and for 1 yearthereafter;

8. Be able to understand the requirements and matters of the trial and be willing toparticipate in the clinical study as required;

9. Sign the trial informed consent form.

Exclusion Criteria:

1. Targeted CNS irradiation within 7 days prior to receiving the first QH104 infusion;

2. Uncontrolled comorbidities including, but not limited to: persistent or activeinfections, symptomatic congestive heart failure, unstable angina, cardiacarrhythmias, or psychiatric/social conditions that would limit the patient's abilityto comply with study requirements;

3. Has a known psychiatric or substance abuse disorder that would interfere withcooperation with trial requirements;

4. Is receiving treatment with any other investigational drug;

5. Have a confirmed diagnosis of an immunodeficiency disorder;

6. Have an active infection requiring systemic treatment;

7. Inability to perform an MRI;

8. Serious cardiovascular compromise: history of New York Heart Association (NYHA)class II or greater congestive heart failure, unstable angina, myocardial infarctionor stroke within 6 months of first dose, or arrhythmia requiring treatment atscreening;

9. Allergy to immunotherapy and related cells;

10. Prior treatment with CAR-T and other immune cell therapy;

11. Other reasons, in the opinion of the investigator, why participation in this studyis not appropriate.