QH101 Cell Injection in Patients With Brain, Brain (Spinal) Meninges, and Spinal Cord Metastatic Malignant Solid Tumors

Inclusion Criteria:

1. Age ≥18 years;
2. ECOG ≤2 or KPS ≥60;
3. Life expectancy ≥8 weeks as assessed by the investigator;
4. Pathologically and/or histologically confirmed malignant tumors with brain, meningeal, and spinal cord metastases that have failed standard therapy or lack standard treatment options may be considered for enrollment;

5. Intracranial metastases must meet the following characteristics:

   Unresectable by craniotomy for solitary/focal (≤3 lesions)/multiple (>3 lesions) intracranial metastases; or inoperable leptomeningeal or spinal cord metastases; Inclusion Criteria Intracranial lesions that progressed after standard treatment, including whole-brain radiotherapy/stereotactic radiosurgery (WBRT/SRS), and are not suitable for repeat radiotherapy;

6. For brain/spinal cord parenchymal metastases, contrast-enhanced MRI must show at least one measurable lesion (according to iRANO criteria); for patients with meningeal lesions only, those deemed likely to benefit from this study by investigator judgment may also be considered for inclusion (efficacy assessed using RANO-LM criteria);

7. Basic normal bone marrow reserve function and normal hepatic and renal function (laboratory tests must meet the following criteria prior to first QH101 administration):

   White blood cell count (WBC) ≥ 3 × 10⁹/L; Lymphocyte count (LY) ≥ 0.8 × 10⁹/L; Hemoglobin (Hb) ≥ 90 g/L; Platelet count (PLT) ≥ 90 × 10⁹/L; Alanine aminotransferase (ALT) & aspartate aminotransferase (AST) < 1.5×ULN; Serum creatinine (Cr) < 1.5×ULN; Total bilirubin < 1.5×ULN; PT & APTT ≤ 1.25×ULN.

8. Pregnancy test must be negative for women of childbearing potential; both male and female subjects must agree to use effective contraception during treatment and for 1 year thereafter;
9. Ability to understand trial requirements and procedures, and willingness to participate in the clinical study as required;
10. Signing of the trial informed consent form.

Exclusion Criteria:

1. Received central nervous system-directed radiation within 7 days prior to the first infusion of QH101;
2. Patients with hematologic malignancies (such as lymphoma, leukemia, etc.) with central nervous system metastases;
3. Patients with metastases in the brainstem and high cervical spinal cord, including midbrain, pons, medulla oblongata, and C1/2 segments of the cervical spinal cord;
4. Patients with significant mass effect from intracranial lesions and signs of increased intracranial pressure (such as severe headache, projectile vomiting, papilledema, altered consciousness, or imaging showing significant edema, midline shift ≥1 cm, compression of peribrain cisterns such as suprasellar cistern, quadrigeminal cistern, interpeduncular cistern, or ambient cistern);
5. Patients with primary or secondary epilepsy/epileptic syndrome that is difficult to control with medication;
6. Uncontrolled comorbidities, including but not limited to: ongoing or active infections, symptomatic congestive heart failure, unstable angina, arrhythmias, or psychiatric/social conditions limiting patient compliance with study requirements;
7. Known psychiatric disorders or substance abuse disorders that may affect compliance with trial requirements;
8. Currently receiving any other investigational treatments;
9. Diagnosed with an immunodeficiency;
10. Patients with active infections requiring systemic treatment;
11. Inability to undergo magnetic resonance imaging (MRI);
12. Severe cardiovascular damage: history of New York Heart Association (NYHA) class II or higher congestive heart failure, unstable angina, myocardial infarction or stroke within 6 months after first dosing, or clinically significant arrhythmias requiring treatment at screening;
13. Allergic to immunotherapy or related cellular therapies;
14. Previously received CAR-T or other cellular immunotherapies;
15. Other reasons that the investigator considers make the patient unsuitable for participation in this study.