Clinical Study of QH104 Cell Injection for the Treatment of Meningeal Metastases of B7H3+ Solid T… (NCT06592092) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study of QH104 Cell Injection for the Treatment of Meningeal Metastases of B7H3+ Solid Tumors
China3 participantsStarted 2024-04-01
Plain-language 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 efficacy of local injection of allogeneic B7H3 CAR-γδ T cells (3\*107/dose) for the treatment of patients with meningeal metastases from B7H3+ solid tumors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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):
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical response
Timeframe: day14
Trial details
NCT IDNCT06592092
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
. 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;
Exclusion criteria
. 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;