Status:
RECRUITING
Clinical Study of QH104 Cell Injection for the Treatment of Meningeal Metastases of B7H3+ Solid Tumors
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Solid Tumor
Meningeal Metastasis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is an open, single-arm, single-center, interventional clinical study. It is planned to enroll 3-6 patients with meningeal metastases from B7H3+ solid tumors and to explore, on a small scale, the ...
Detailed Description
This study is an open, single-arm, single-center, interventional clinical study. It is planned to enroll 3-6 patients with meningeal metastases from B7H3+ solid tumors and to explore, on a small scale...
Eligibility Criteria
Inclusion
- Age ≥18 years;
- Have a histologically or cytologically confirmed solid malignant tumor with positive B7H3 expression;
- ECOG ≤ 2 or KPS ≥ 60;
- Life expectancy ≥ 8 weeks as assessed by the investigator;
- 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;
- 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.
- 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;
- Be able to understand the requirements and matters of the trial and be willing to participate in the clinical study as required;
- Sign the trial informed consent form.
Exclusion
- Targeted CNS irradiation within 7 days prior to receiving the first QH104 infusion;
- 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;
- Has a known psychiatric or substance abuse disorder that would interfere with cooperation with trial requirements;
- Is receiving treatment with any other investigational drug;
- Have a confirmed diagnosis of an immunodeficiency disorder;
- Have an active infection requiring systemic treatment;
- Inability to perform an MRI;
- 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;
- Allergy to immunotherapy and related cells;
- Prior treatment with CAR-T and other immune cell therapy;
- Other reasons, in the opinion of the investigator, why participation in this study is not appropriate.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06592092
Start Date
April 1 2024
End Date
December 31 2027
Last Update
September 19 2024
Active Locations (2)
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1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
2
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021