QH104 Cell Injection for Treating Meningeal Metastases in Solid Tumors

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

This study is testing if injecting a special type of immune cell can help people with meningeal metastases from certain solid tumors feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other)
• Drugs / interventions: CAR-T, immunotherapy
• Locations: 2 sites (Beijing, Beijing and 1 other locations)
• Trial ID: NCT06592092 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the efficacy of local injection of allogeneic B7H3 CAR-γδ T cells in patients with meningeal metastases from B7H3+ solid tumors. It is an open, single-arm, single-center interventional study that plans to enroll 3-6 patients. Participants may receive multiple infusions of the cell therapy based on their clinical response and assessments by the investigator. The study will monitor the patients' neurological function and cerebrospinal fluid cytology to determine the potential benefits of continued treatment.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed B7H3+ solid tumors and meningeal metastases that are refractory to standard treatments.

Not a fit: Patients with solid tumors that do not express B7H3 or those with standard treatment options available may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients with meningeal metastases from B7H3+ solid tumors.

How similar studies have performed: While this approach is novel, similar studies targeting specific tumor markers with CAR T-cell therapies have shown promising results in other contexts.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years;
2. Have a histologically or cytologically confirmed solid malignant tumor with positive B7H3 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 solid malignancy that is refractory to standard treatment or for which no standard treatment is available and positive cerebrospinal fluid (CSF) cytology;
6. Substantially normal bone marrow reserve function and normal hepatic and renal function (laboratory tests are required to be satisfied prior to first treatment with 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; Total bilirubin \< 1.5 x ULN; PT \& PTT ≤ 1.25 × ULN.
7. Pregnancy test should be negative for women of childbearing potential and both men and women agree to use effective contraception during treatment and for 1 year thereafter;
8. Be able to understand the requirements and matters of the trial and be willing to participate 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 active infections, symptomatic congestive heart failure, unstable angina, cardiac arrhythmias, or psychiatric/social conditions that would limit the patient's ability to comply with study requirements;
3. Has a known psychiatric or substance abuse disorder that would interfere with cooperation 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 infarction or stroke within 6 months of first dose, or arrhythmia requiring treatment at screening;
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 study is not appropriate.

Where this trial is running

Beijing, Beijing and 1 other locations

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing, China (RECRUITING)
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Ning Li, Ph.D — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Ning Li, Ph.D

Conditions: Solid Tumor, Meningeal Metastasis, B7H3 positive；, CAR-γδT cell