Solid TumorNCT06592092
Clinical Study of QH104 Cell Injection for the Treatment of Meningeal Metastases of B7H3+ Solid Tumors
A study testing QH104 Cell injection in people with Solid Tumor and Meningeal Metastasis, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Meningeal Metastasis
- What is being tested?
- QH104 Cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 28 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
Show all 10Show fewer
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
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.
Read 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, the clinical response to local injection of allogeneic B7H3 CAR-γδ T cells (3*107/dose) for the treatment of patients with meningeal metastases from B7H3+ solid tumors. During the period of cell therapy, the enrolled subjects may be given additional multiple infusions of cells, after imaging, neurological function, cerebrospinal fluid cytology or the investigator's assessment of the potential benefit of continuing cell therapy. It is recommended that the frequency of multiple infusions be 2 weeks each, and the interval between infusions can be adjusted at a later stage based on the PK and clinical symptoms of the subject after infusion.
- Conditions
- Solid Tumor, Meningeal Metastasis
- Being tested
- QH104 Cell injection
- Keywords
- B7H3 positive；, CAR-γδT cell
- Medical subject headings
- Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QH104 Cell injectionBiological
Patients will first be pre-screened for B7H3 expression of tumor and exist Meningeal Metastases.
| Study group | Role | What they receive |
|---|---|---|
| QH104 cell Injection(Allogenic B7H3 CAR-γδT cell) | Experimental | Plan to enroll 3 to 6 patients with meningeal metastasis of B7H3+ solid tumor with single or multiple local injections of allogenic B7H3 CAR-γδ T cells (3*107/ dose) Receives: Biological: QH104 Cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
Evaluate the clinical response of QH104 cell injection in treating B7H3+ solid tumor meningeal metastases according to the Response Assessment in Neuro-Oncology (RANO) criteria
Measured: day14
Secondary outcomes (5)
Overall survival(OS)
OS is defined as the time from QH104 cells infusion to the date of death.
Measured: 3month,6month,12month
Incidence of Adverse Events (AEs)
AE is defined as any adverse medical event from the date of infusion to 14 days after QH104 infusion. Among them, cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) were graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria, graft-versus host disease (GVHD) according to criteria defined by the Mount Sinai Acute GVHD International Consortium. Other AEs were graded according to common terminology criteria for adverse events (CTCAE) v5.0.
Measured: day14 and day 28
quality of life(QoL) score
Use the M.D. Anderson Symptom Inventory for Brain Tumors (MDASI-BT) to evaluate quality of life for all enrolled subjects, with assessments conducted prior to each cell infusion and during follow-up.
Measured: day 14 and day 28
Pharmacokinetic (PK)
Assess the pharmacokinetics (PK) of QH104 cell infusion in B7H3+ solid tumor meningeal metastases by monitoring the quantity of CAR+ cells, their subpopulations following QH104 cell reinfusion.
Measured: At days 0, 1, 3, 7, and 14
Pharmacodynamic (PD)
Assess the pharmacodynamics (PD) of QH104 cell infusion in B7H3+ solid tumor meningeal metastases by monitoring the quantity of CAR+ cells, their subpopulations, differentiation, exhaustion, and cytokine changes in the cerebrospinal fluid following QH104 cell reinfusion.
Measured: At days 0, 1, 3, 7, and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Apr 2024
- Primary completion31 May 2025
- Study completion28 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ning Li, Ph.D, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592092
- Sponsor's protocol ID
- QH10402-LMD-01
- Status last verified
- Jan 2026
- First submitted
- 17 Mar 2024
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of QH104 Cell Injection for the Treatment of Meningeal Metastases of B7H3+ Solid Tumors
- ClinicalTrials.gov ID
- NCT06592092
- Acronym / sponsor ID
- QH10402-LMD-01
- Conditions
- Solid Tumor, Meningeal Metastasis
- Keywords
- B7H3 positive；, CAR-γδT cell
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 28 Jan 2026 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, the clinical response to local injection of allogeneic B7H3 CAR-γδ T cells (3*107/dose) for the treatment of patients with meningeal metastases from B7H3+ solid tumors. During the period of cell therapy, the enrolled subjects may be given additional multiple infusions of cells, after imaging, neurological function, cerebrospinal fluid cytology or the investigator's assessment of the potential benefit of continuing cell therapy. It is recommended that the frequency of multiple infusions be 2 weeks each, and the interval between infusions can be adjusted at a later stage based on the PK and clinical symptoms of the subject after infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QH104 cell Injection(Allogenic B7H3 CAR-γδT cell) | Experimental | Biological: QH104 Cell injectionPlan to enroll 3 to 6 patients with meningeal metastasis of B7H3+ solid tumor with single or multiple local injections of allogenic B7H3 CAR-γδ T cells (3*107/ dose) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QH104 Cell injectionPatients will first be pre-screened for B7H3 expression of tumor and exist Meningeal Metastases. | Biological | QH104 cell Injection(Allogenic B7H3 CAR-γδT cell) |
Primary outcome
Clinical response
Time frame: day14
Evaluate the clinical response of QH104 cell injection in treating B7H3+ solid tumor meningeal metastases according to the Response Assessment in Neuro-Oncology (RANO) criteria
5 secondary outcomes
Overall survival(OS)
Time frame: 3month,6month,12month
Incidence of Adverse Events (AEs)
Time frame: day14 and day 28
quality of life(QoL) score
Time frame: day 14 and day 28
Pharmacokinetic (PK)
Time frame: At days 0, 1, 3, 7, and 14
Pharmacodynamic (PD)
Time frame: At days 0, 1, 3, 7, and 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ning Li, Ph.D principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QH104 Cell injection in people with Solid Tumor and Meningeal Metastasis, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response (time frame: day14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.