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High-grade GliomaPhase 1NCT06482905

Safety and Efficacy Study of TX103 CAR-T Cell Therapy for Recurrent or Progressive Grade 4 Glioma.

A Phase 1 study testing Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103 in people with High-grade Glioma and WHO Grade Ⅳ Glioma, run by Tcelltech Inc. at 4 sites in 2 countries.

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

This is a phase I, open-Label, single/multiple dose, dose-escalation study to evaluate the safety, tolerability and antitumor activity of anti-B7-H3 CAR-T cell injection (TX103) in subjects with recurrent or progressive Grade 4 Glioma.The study also plan to explore the Maximum Tolerated Dose (MTD) and determine the… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
High-grade Glioma, WHO Grade Ⅳ Glioma
What is being tested?
Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
4 sitesin 2 countries
Study dates
4 Sep 2024to Jun 2027
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

  • Subjects must voluntarily participate in the study and sign a written informed consent document; subjects should be willing and able to follow and complete study procedures.
  • Male or female subjects aged 18 to 75 years (both inclusive).
  • Subject must have histologically diagnosed grade 4 glioma, such as glioblastoma, grade 4 astrocytoma, diffuse hemispheric glioma, according to 2021 WHO Classification of Tumors of the CNS. Subjects must have had experienced disease recurrence or progression* after surgery combined with Stupp regimen (concurrent radiotherapy and temozolomide (TMZ) followed by adjuvant TMZ) and are not candidate for re-resection. For subjects harboring specific gene mutations, such as NTRK gene fusion or BRAF V600E mutation, they must have also progressed on corresponding mutation-directed therapies before enrollment.
  • Disease recurrence or progression must be confirmed by radiographic or histopathological diagnosis.
  • Subjects with confirmed B7-H3 positive* (≥30%) tumor expression by immunohistochemistry (IHC) in either primary or recurrent tumor tissue.
  • B7-H3 positive rate is defined as the percentage of B7-H3 positive tumor cells in non-necrotic tumor tissue.
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  • Subjects with KPS score of ≥60.
  • Subjects should have adequate venous access for collection of peripheral blood mononuclear cells (PBMCs).
  • Subjects with left ventricular ejection fraction (LVEF) ≥ 40% within one month prior to the first dose.
  • Subjects with oxygen saturation ≥95% under the resting state.
  • Subjects with adequate organ function, as indicated by laboratory test results that meet the following criteria:
  • Hematological function: Absolute neutrophil count (ANC) ≥1.5×109/L, hemoglobin (Hb) ≥90g/L, platelet count (PLT) ≥100×109/L, absolute lymphocytes count (ALC) ≥0.15×109/L. Blood transfusion, granulocyte (macrophage) colony stimulating factor, recombinant human erythropoietin, recombinant human thrombopoietin, platelet receptor agonist, recombinant human interleukin-11, and other supportive treatments are prohibited within 14 days before the test.
  • Liver function: Total bilirubin (TBIL) ≤ 1.5 × ULN, patients with Gilbert's syndrome (persistent or recurrent hyperbilirubinemia, presenting as unconjugated bilirubin in the absence of evidence of hemolysis or liver pathology) Except for elevated erythrocytes; alanine aminotransferases (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN.
  • Renal function: serum creatinine (Scr) ≤1.5×ULN.
  • Coagulation function (in the absence of anticoagulant therapy): prothrombin time (PT) or activated partial thromboplastin time (APTT) or international normalized ratio (INR) ≤ 1.5×ULN.
  • Female subjects of childbearing potential must have a negative serum pregnancy test at screening and if a positive urine test or a negative result cannot be confirmed by urine test.
  • Women of childbearing potential (which refer to women who have not been surgically sterilized and pre-menopausal women) should use highly effective and reliable method of contraception (refer to Section 5.3 for contraception method) from the start of the study until 6 months after the last dose of the study drug; sexually active male subjects, if no vas deferens for ligation, consent must be given to the use of highly effective and reliable method of contraception from the start of the study until 6 months after the last dose of the study drug.

Who cannot join

  • Pregnant or breastfeeding female subjects.
  • Subjects with viral infection during the screening period:
  • Serum HIV antibody positive, treponema pallidum serology positive; OR
  • Hepatitis B surface antigen (HBsAg) positive and peripheral blood HBV DNA test value exceeds the normal range; OR
  • Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive.
  • Medical history and concomitant diseases:
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  • Subjects who have received carmustine extended-release implantation surgery within 6 months;
  • Subjects with known or suspected active autoimmune diseases, including but not limited to Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.;
  • Subjects who are receiving systemic immunosuppressive agents or subjects who need to use immunosuppressive agents for a long-time during treatment, except for intermittent topical, inhaled, or intranasal glucocorticoid therapy;
  • Subjects with uncontrolled mental disorders, or who, in the Investigator's opinion, have a medical history or a history of mental states that may increase the risks associated with study participation or study drug administration, or that may interfere with the results;
  • The toxicity and side effects caused by previous treatment have not recovered to ≤ grade 1 (per CTCAE 5.0); except for alopecia and other tolerable events judged by the Investigator;
  • Subjects who have participated in other interventional clinical studies within the past 1 month;
  • Subjects who have previously received CAR-T cell therapy or other gene therapy*;
  • Subjects with any serious or poorly controlled disease that, in the opinion of the Investigator, may increase the risk associated with study participation, study drug administration, or affect the subject's ability to receive study drug, including but not limited to cardiovascular and cerebrovascular diseases, renal insufficiency, pulmonary embolism, coagulopathy or requiring long-term anticoagulant therapy, active infection or uncontrollable infection requiring long-term systemic treatment;
  • Subjects with other malignant tumors in the past 3 years or at present, except for non-melanoma skin cancer, carcinoma in situ (such as cervix, bladder and breast cancer).

Trial locations and contacts

4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Rui Feng, MD contact

+(86)13509312934

fengrui@tcelltech.com

Xianzhen Chen, MM contact

+(86)18649725652

chenxianzhen@tcelltech.com

4 sites in 2 countries

United States3 sites, 3 recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

    Wendy J. Sherman, M.D.

    Recruiting

  • Mayo Clinic in Arizona

    Phoenix, Arizona, 85054

    Maciej M. Mrugala, M.D., Ph.D.

    Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Lia Tipton, MD.,PhD., tipton.lia@mayo.edu

    Recruiting

Other trials in United States

China1 site, 1 recruiting

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality, 100730

    Yang Zhang, Dr., 010-59976516, zhangyang8025@163.com

    Nan Ji, MD

    Recruiting

Other trials in China

About this study

Official title: A Phase I, Open-Label, Single/Multiple Dose, Dose-escalation Study to Evaluate the Safety, Tolerability and Antitumor Activity of TX103 CAR-T Cell Injection (TX103) in Subjects With Recurrent or Progressive Grade 4 Glioma.

This is a phase I, open-Label, single/multiple dose, dose-escalation study to evaluate the safety, tolerability and antitumor activity of anti-B7-H3 CAR-T cell injection (TX103) in subjects with recurrent or progressive Grade 4 Glioma.The study also plan to explore the Maximum Tolerated Dose (MTD) and determine the Recommended Phase II Dose (RP2D) of the CAR-T cell therapy.

Read the detailed description

Eligible subjects will be enrolled into two sequential dose-escalating cohorts (i.e., A and B), and will be administrated TX103. Cohort A will receive TX103 exclusively through intraventricular (ICV) delivery, while cohort B will undergo dual intracavitary (ICT) and ICV delivery. Patients in each individual cohort will receive two TX103 infusions on Day 1 and 8 respectively, followed by a 14-day observation period in a 21-day treatment cycle.

Three escalating dosage levels are planned for each cohort. Both Cohorts A and B will adopt the traditional 3+3 dose escalation design with each dose level enrolled with 3 to 6 patients. The starting dose will be 6 × 10^7 CAR+ T cells (i.e., Dose Level 1, DL1). Dose limiting toxicities (DLTs) will be assessed during the first cycle .

Being tested
Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103
Medical subject headings
Glioma

What participants receive

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

  • Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103Biological

    Safety Run-In: Dose:6×10^7 CAR+ T cells

    Cohort A Single delivery route(Multi-dose)、Cohort B Dual delivery route(Multi-dose)： 3+3 dose escalation design： Dose Level 1: 6×10^7 CAR+ T cells Dose Level 2: 1.5×10^8 CAR+ T cells Dose Level 3: 2.5×10^8 CAR+ T cells

Study groups in NCT06482905
Study groupRoleWhat they receive
Safety Run-InExperimentalSingle-dose administration of TX103 via intraventricular(ICV) or intracavitary (ICT) .
Receives: Biological: Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103
Cohort A Single delivery route(Multi-dose)ExperimentalAdministration of TX103 via intraventricular(ICV) on Days 1 and 8 in a 21-day treatment cycle.
Receives: Biological: Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103
Cohort B Dual delivery route(Multi-dose)ExperimentalAdministration of TX103 on Day 1 via intracavitary (ICT) and on Day 8 via intraventricular(ICV) in a 21-day treatment cycle.
Receives: Biological: Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103

What is being measured

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

  1. Safety：Incidence of Dose Limiting Toxicity (DLT)

    Type, incidence, and severity of dose limiting toxicities (DLTs) within 28 days after the first TX103 infusion.

    Measured: 28 days after the first TX103 infusion.

  2. Safety：Incidence and severity of adverse events (AEs)

    To evaluate the possible adverse events after TX103 infusion, including the incidence, and severity of AEs.

    Measured: six months post CAR-T cells infusion.

Secondary outcomes (10)

  1. Overall survival (OS)

    The proportion of subjects who have survived for more than 6 and12 months since the diagnosis of recurrent or progressive Grade 4 Glioma.

    Measured: 6 and 12 months post CAR-T cells infusion.

  2. Post-relapse survival (PRS)

    The proportion of subjects who have survived for more than 6 and12 months since the diagnosis of recurrent or progressive Grade 4 Glioma.

    Measured: 6 and 12 months post CAR-T cells infusion.

  3. Progression Free Survival (PFS)

    To evaluate the time from the start of TX103 therapy to disease progression (according to RANO2.0 criteria) or death from any cause, whichever occurs first. The proportion of progression-free subjects from the beginning of TX103 therapy to a fixed time point (6 months) after treatment (6-Mon PFS) will also be evaluated.

    Measured: 1 year post CAR-T cells infusion.

  4. Disease Control Rate (DCR)

    To evaluate the proportion of subjects who achieved CR/PR/SD in the best overall response according to RANO2.0 criteria.

    Measured: 1 year post CAR-T cells infusion.

  5. Duration of disease control (DDC)

    To evaluate the time from the first evaluation of tumor as CR, PR or SD to the first evaluation of PD or death from any cause.

    Measured: 1 year post CAR-T cells infusion.

  6. Objective response rate (ORR)

    To evaluate the proportion of subjects who achieved CR/PR in the best response condition according to RANO2.0 criteria.

    Measured: 1 year post CAR-T cells infusion.

  7. Time to Remission (TTR)

    To evaluate the time from the start of treatment to the first remission (CR/PR).

    Measured: 1 year post CAR-T cells infusion.

  8. Duration of Response (DOR)

    DOR after TX103 infusion, defined as the time from the first evaluation of the tumor as CR or PR to the first evaluation of PD or death from any cause.

    Measured: 1 year post CAR-T cells infusion.

  9. Neurological function evaluated by NANO scale

    Change in neurological function from baseline.

    Measured: 1 year post CAR-T cells infusion.

  10. Quality of life score

    Change in Quality of life score from baseline.

    Measured: 1 year post CAR-T cells infusion.

Timeline

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

  1. First posted1 Jul 2024
  2. Study start4 Sep 2024
  3. Primary completionSep 2026 (estimated)
  4. Study completionJun 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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
a "3+3" design is used to determine Maximum Tolerated Dose (MTD) and the recommended phase 2 dose (RP2D)
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06482905
Sponsor's protocol ID
TX103T-RG008
Status last verified
Apr 2025
First submitted
15 Jun 2024
Last updated
24 Mar 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103 in people with High-grade Glioma and WHO Grade Ⅳ Glioma, run by Tcelltech Inc. at 4 sites in 2 countries.

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 17 inclusion and 15 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 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, 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?

Contact Rui Feng, MD (+(86)13509312934, fengrui@tcelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety：Incidence of Dose Limiting Toxicity (DLT) (time frame: 28 days after the first TX103 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 NCT06482905.

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 24 Mar 2026.

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