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GlioblastomaPhase 1NCT05241392

Safety and Efficacy Study of Anti-B7-H3 CAR-T Cell Therapy for Recurrent Glioblastoma

A Phase 1 study testing B7-H3-targeting CAR-T cells/TX103-CAR-T Cell Injection in people with Glioblastoma, run by Beijing Tiantan Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is an open-label, single-arm, dose-escalation and multiple-dose study to evaluate the safety, tolerability, and preliminary efficacy of TX103-CAR-T Cell Injection, a B7-H3-targeting chimeric antigen receptor T-cell (CAR-T) therapy, in patients with recurrent glioblastoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Glioblastoma
What is being tested?
B7-H3-targeting CAR-T cells/TX103-CAR-T Cell Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
27 Jan 2022to 31 Dec 2026
Phase
Phase 1
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, aged 18-75 years (including 18 and 75 years old)；
  • Patients with relapsed glioblastoma, as confirmed by positron emission tomography (PET) or histologic pathology；
  • A >= 30% staining extent of B7-H3 in his/her primary/recurrent tumor tissue by the immunochemical method;
  • Karnofsky scale score>=50
  • Availability in collecting peripheral blood mononuclear cells (PBMCs) ；
  • Adequate laboratory values and adequate organ function;
  • Patients with childbearing/fathering potential must agree to use highly effective contraception；

Who cannot join

  • Pregnant or breastfeeding females；
  • Contraindication to bevacizumab；
  • Within 5 days before the CAR-T cell infusion, subjects receiving systemic administration of steroids with dosage more than 10mg/d prednisone or the equivalent doses of other steroids ( not including inhaled corticosteroid)；
  • Comorbid with Other uncontrolled malignancy；
  • Active immunodeficiency virus (HIV) or hepatitis B virus or hepatitis C virus or tuberculosis infection;
  • Subjects receiving the placement of a carmustine slow-release wafer within 6 months before the enrollment;
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  • Autoimmune diseases;
  • Receiving long-term immunosuppressive treatment after organ transplantation;
  • Severe or uncontrolled psychiatric diseases or condition that could increase adverse events or interfere the evaluation of outcomes;
  • Not recovered from the toxicities or side effects by previous treatment;
  • Subjects who have participated the other interventional trial within one month before the enrollment, or have received other CAR-T cell therapies or gene-modified cell therapy before enrollment.
  • Subjects with medical conditions that affect signing the written informed consent or complying with the research procedures, the medical conditions including, but not limited to cardio-cerebral vascular diseases, renal dysfunction/failure, pulmonary embolism, coagulation disorders, active systemic infection, uncontrolled infection et. al; or patients who are unwilling or unable to comply with the research procedures; these
  • Subjects with other conditions that would interfere trial participation at the investigator's discretion.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: An Open, Single-arm, Phase 1 Study to Evaluate the Safety/Preliminary Effectiveness and Determine the Maximal Tolerated Dose of B7-H3-targeting CAR-T Cell Therapy in Treating Recurrent Glioblastomas

This is an open-label, single-arm, dose-escalation and multiple-dose study to evaluate the safety, tolerability, and preliminary efficacy of TX103-CAR-T Cell Injection, a B7-H3-targeting chimeric antigen receptor T-cell (CAR-T) therapy, in patients with recurrent glioblastoma. The study also aims to explore the maximum tolerated dose (MTD) and determine the recommended Phase II dose (RP2D) of TX103-CAR-T Cell Injection.

Conditions
Glioblastoma
Being tested
B7-H3-targeting CAR-T cells/TX103-CAR-T Cell Injection
Medical subject headings
Glioblastoma

What participants receive

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

  • B7-H3-targeting CAR-T cells/TX103-CAR-T Cell InjectionBiological

    Patients will be treated with anti-B7-H3 autologous CAR-T cells that are delivered into the intracranial tumor resection cavity or ventricular system using an Ommaya device.

Study groups in NCT05241392
Study groupRoleWhat they receive
CAR-T cell therapyExperimentalDose-escalation phase: A "3+3" dose-escalation design is used to determine MTD \& R2PD. Anti-B7-H3 autologous CAR-T cells were given biweekly to patients at the following doses for each cycle, and 4 cycles as one course. Dose1: 3 patients at a dose of 20 million cells for each cycle. Dose 2: 3 patients at a dose of 60 million cells for each cycle. Dose 3: 3 patients at a dose of 150 million cells for each cycle. Dose 4: 3 patients at a dose of 450 million cells for each cycle. Dose 5: 3 patients at a dose of 900 million cells for each cycle. R2PD confirmation phase: Determine the R2PD based on the results from the previous dose-escalation study; Treat another 12 patients with anti-B7-H3 autologous CAR-T cells biweekly at the R2PD to further confirm the safety of R2PD. At each dose phase, if the patients show tolerate and response to the treatment, these patients would receive several courses of treatment at PI's discretion.
Receives: Biological: B7-H3-targeting CAR-T cells/TX103-CAR-T Cell Injection

What is being measured

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

  1. Incidence of Dose Limiting Toxicity (DLT)

    To evaluate the DLT incidence occurred within three months after B7-H3 CAR-T cells infusion

    Measured: three months post CAR-T cells infusion

  2. Safety：Incidence and severity of adverse events

    To evaluate the possible adverse events occurred within three months after B7-H3 CAR-T cell infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity

    Measured: three months post CAR-T cells infusion

Secondary outcomes (5)

  1. Efficacy：Overall survival rate at 12 months

    The proportion of subjects who have survived for more than 12 months since the diagnosis of recurrent glioblastoma

    Measured: 12 months post CAR-T cells infusion

  2. Efficacy：objective remission rate

    The proportion of subjects reaching complete remission / partial remission in optimal remission

    Measured: 1, 2, 3, 4, 5, 6 months post CAR-T cells infusion

  3. pharmacokinetics：Cmax

    observed maximum plasma concentration (Cmax)

    Measured: Samples collected pre-injection, and 1, 2, 3, 5, 7, 9, 11,13 days post the first injection; Samples collected pre-injection, and 2, 7, 13 days post re-injections

  4. pharmacokinetics：Tmax

    time to reach maximum plasma concentration (tmax)

    Measured: Samples collected pre-injection, and 1, 2, 3, 5, 7, 9, 11,13 days post the first injection; Samples collected pre-injection, and 2, 7, 13 days post re-injections

  5. pharmacokinetics：AUC

    area under the plasma concentration-time curve from time zero to 28 days after dosing (AUC(0-28))

    Measured: Sample taken pre-injection, and 1, 2, 3, 5, 7, 9, 11,13 days post the first injection; Sample taken pre-injection, and 2,7,13 days post re-injections

Timeline

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

  1. First posted15 Feb 2022
  2. Study start27 Jan 2022
  3. Primary completion30 Nov 2024
  4. Study completion31 Dec 2026 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
A "3+3" dose-escalation design is used to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of TX103-CAR-T Cell Injection.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05241392
Sponsor's protocol ID
TX103T-IG005
Status last verified
Oct 2026
First submitted
13 Jan 2022
Last updated
26 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang Y, Chi X, Feng R, Xian N, Huang N, Sun S, Zhao X, Zhang P, Liu K, Ma Y, Zhang Y, Zhang K, Wang S, Chen X, Zhang J, Huang W, Huang B, Su TT, Yeung J, He J, Chen L, Ji N, Huang G. Intracranial delivery of B7-H3-targeting CAR-T cells for recurrent glioblastoma: a phase 1 trial. Nat Med. 2026 Aug 6. doi: 10.1038/s41591-026-04557-6. Online ahead of print.

    PubMed 42562965

  • Golubovskaya V. CAR-T Cells Targeting Immune Checkpoint Pathway Players. Front Biosci (Landmark Ed). 2022 Apr 2;27(4):121. doi: 10.31083/j.fbl2704121.

    PubMed 35468680

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing B7-H3-targeting CAR-T cells/TX103-CAR-T Cell Injection in people with Glioblastoma, run by Beijing Tiantan Hospital 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 7 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 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.

What does this 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.

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?

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?

Incidence of Dose Limiting Toxicity (DLT) (time frame: three months post CAR-T cells infusion). The study lists 2 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 NCT05241392, which also lists 2 linked publications.

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 26 Oct 2026.

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