AzTrials
AzTrials

Brain GliomasPhase 1/2NCT06018363

Clinical Study on the Treatment of Malignant Brain Glioma by QH104 Cell Injection

A Phase 1/2 study testing Allogenic B7-H3 CAR-γδT cell(QH104) in people with Brain Gliomas and High-Grade Gliomas, run by Dushu Lake Hospital Affiliated to Soochow University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

B7-H3 is expressed at low levels in normal tissues but overexpressed in various tumor tissues. The ubiquitous expression of B7-H3 in tumors of different grades is a key feature for brain gliomas. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Brain Gliomas, High-Grade Gliomas, GBM
What is being tested?
Allogenic B7-H3 CAR-γδT cell(QH104)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
1 Jun 2023to 31 Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1)Age 18-70 years old (both ends included), both male and female;
  • 2)At least one evaluable lesion, with previous biopsy or histopathological confirmation of high-grade glioma (WHO grade 3-4), and after comprehensive treatment, imaging examination indicates continued progression or recurrence;
  • 3) The pathological tissues removed by surgery can be used for immunohistochemical detection of target proteins (paraffin sections should be within half a year), and the expression of B7-H3 is positive;
  • 4) KPS ≥ 60 points;
  • 5)Expected survival > 3 months;
  • 6)Substantially normal bone marrow reserve function and normal liver and renal function (laboratory tests need to be fulfilled before receiving QH104 Cell Injection for the first time):White blood cell count (WBC) ≥ 3 x 10^9/L;Lymphocyte count (LY) ≥ 0.8 x 10^9/L;Hemoglobin (Hb) ≥ 90g/L;Platelet (PLT) ≥80×10^9/L;Albumin transaminase (ALT) \& albumin transaminase (AST) <1.5×ULN;Serum creatinine (Cr) <1.5 x ULN;Total bilirubin < 1.5 x ULN;PT \& PTT ≤ 1.25 x ULN.
Show all 11Show fewer
  • 7)No obvious hereditary diseases;
  • 8)Normal cardiac function with cardiac ejection index >55%;
  • 9)No bleeding and coagulation disorders;
  • 10)Women of childbearing age (15-49 years old) must have had a pregnancy test with a negative result within 7 days prior to the start of treatment, and subjects are willing to use contraception during the clinical trial and for 3 months after the last cell infusion;
  • 11) Sign the informed consent form.

Who cannot join

  • 1)Pregnant and lactating women;
  • 2)Those with organ failure:Heart: Class III and IV;Liver: up to grade C of the Child-Turcotte Liver -Function Classification;Kidney: chronic kidney disease stage 4 or above; renal insufficiency stage III or above;Lungs: symptoms of severe respiratory failure with involvement of other organs;Brain: central nervous system abnormalities or impaired consciousness;
  • 3)patients with combined second tumors;
  • 4)patients with active hepatitis B or C virus, HIV infection, or other untreated active infection;
  • 5)any severe, uncontrolled systemic autoimmune disease or any unstable systemic disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and temporal arteritis;
  • 6)Current systemic use of steroid cell (except for recent or current use of inhaled steroids) substances;
Show all 11Show fewer
  • 7) have a chronic disease requiring immunologic or hormonal therapy;
  • 8) have an allergy to immunotherapy and related cells;
  • 9) 10)Patients with a history of organ transplantation or who are awaiting organ transplantation;
  • 10)Participation in other clinical trials within the previous 30 days;
  • 11)Those who are not suitable for clinical trials for other reasons in the opinion of the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Dushu Lake Hospital Affiliated to Soochow University

    Suzhou, Jiangsu, 215125

    Yulun Huang, +86 130 1388 9432, huangyulun@suda.edu.cn

    Xuetao Li, +86 151 9563 7789, lixuetao0405@126.com

    Recruiting

Other trials in China

About this study

Official title: Allogeneic B7-H3 CAR-γδT Cell Therapy Recurrent/Progressive High Grade Glioma（R/R HGG）

B7-H3 is expressed at low levels in normal tissues but overexpressed in various tumor tissues. The ubiquitous expression of B7-H3 in tumors of different grades is a key feature for brain gliomas. The immunohistochemistry study showed that B7-H3 is abundantly expressed on both glioma (especially high-grade glioma) cells and tumor-associated endothelial cells. For GBM, the expression of B7-H3 is intensely positive, especially on tumor cells and vascular endothelial cells, which makes B7-H3 a potential immunotherapeutic target.

γδ T cells recognize tumor cells without being restricted by MHC molecules, and thus can be used in allogeneic therapy without the risk of causing graft-versus-host disease.

This study is an open-label, single-arm, dose-escalation and dose-expansion clinical study aimed at evaluating the safety and efficacy of allogeneic B7-H3 CAR γδT in patients with malignant glioma.

Being tested
Allogenic B7-H3 CAR-γδT cell(QH104)
Keywords
B7-H3, CAR-γδT, allogeneic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Allogenic B7-H3 CAR-γδT cell(QH104)Biological

    Dose escalation (3+3) : dose 1 (1 × 10^7 CAR+cells) , dose 2 (3 × 10^7 CAR+cells), dose 3 (6× 10^7 CAR+cells), once every 4 weeks via an Ommaya reservoir or intrathecal administration.

    Dose expansion 1: dose of RP2D, once every 4 weeks via an Ommaya reservoir or intrathecal administration.

    Dose expansion 2: 3 × 10^7 CAR+cells, every two weeks for three consecutive months, then changed to once every 4 weeks via an Ommaya reservoir or intrathecal administration.

Study groups in NCT06018363
Study groupRoleWhat they receive
Patients with R/R HGGExperimentalNot described
Receives: Biological: Allogenic B7-H3 CAR-γδT cell(QH104)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Incidence of Adverse Events (AEs)

    AE is defined as any adverse medical event from the date of the cell infusion to 12 months after B7-H3 CAR-γδT cells 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: 12 months

  2. Phase 1:Incidence of Dose-Limiting Toxicities (DLTs)

    DLT was defined as B7-H3 CAR-γδT cells-related events with onset within first 28 days following infusion

    Measured: 28 days after the first dose of B7-H3 CAR-γδT cells

  3. Phase 1:Maximum tolerated dose (MTD)

    Measured: 28 days after the first dose of B7-H3 CAR-γδT cells

  4. Phase 1: Recommended phase 2 dose (RP2D)

    Measured: 28 days after the first dose of B7-H3 CAR-γδT cells

Secondary outcomes (5)

  1. Pharmacokinetics: copy number of B7-H3 CAR-γδT cells in cerebrospinal fluid(CSF)

    Measured: 28 days after the first dose of B7-H3 CAR-γδT cells

  2. Pharmacodynamics: Peak level of cytokines in CSF

    Measured: 28 days after the first dose of B7-H3 CAR-γδT cells

  3. Phase 2: Overall survival (OS)

    Measured: 6 months, 9 months and 12 months

  4. Phase 2: Progression Free Survival (PFS)

    Measured: 6 months

  5. Disease Control Rate (DCR)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2023
  2. Study start1 Jun 2023
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06018363
Sponsor's protocol ID
QH10401-GC-01（0）
Status last verified
Aug 2025
First submitted
25 Aug 2023
Last updated
19 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Allogenic B7-H3 CAR-γδT cell(QH104) in people with Brain Gliomas and High-Grade Gliomas, run by Dushu Lake Hospital Affiliated to Soochow University 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 11 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: looking for participants now, as of the sponsor's last update on 19 Aug 2025. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Incidence of Adverse Events (AEs) (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06018363.

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 19 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in