R/R Grade 4 GliomaEarly Phase 1NCT07384390
TH-CAR-027 for Grade 4 Gliomas
A Early Phase 1 study testing TH-CART-027 in people with R/R Grade 4 Glioma, run by Shanghai Tongji Hospital, Tongji University School of Medicine.
Trial summary
This is an open-Label, dose-escalation, multiple administration, exploratory clinical study to evaluate the safety, tolerability, and anti-tumor activity of TH-CART-027 cell injection in subjects with recurrent or progressive grade 4 glioma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- R/R Grade 4 Glioma
- What is being tested?
- TH-CART-027
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2026to 31 Aug 2029
- Phase
- Early 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
- 1. Voluntarily participate in the clinical trial; fully understand and are informed about this study and sign the informed consent form; willing and able to comply with and complete all trial procedures.
- 2. Male or female patients aged ≥18 years and ≤75 years. 3. Disease Status: Diagnosis of Grade 4 glioma as defined by the 2021 WHO Classification of Tumors of the Central Nervous System, including but not limited to glioblastoma, Grade 4 astrocytoma, and diffuse hemispheric glioma. Subjects must have experienced relapse or progression following standard therapy and are unsuitable for or refuse further surgical resection. Subjects with specific genetic mutations (e.g., NTRK gene fusion or BRAF V600E mutation) must have progressed after receiving corresponding targeted therapy to be eligible. Documentation of relapse/progression must include imaging (MRI or PET) or histopathological confirmation.
- 4. B7-H3 Expression: ≥30% positivity for B7-H3 molecule in primary/relapsed tumor tissue by pathological testing. B7-H3 positivity is defined as: the percentage of B7-H3-positive tumor cells among total viable tumor cells in non-necrotic tumor tissue areas ≥30%.
- 5. Karnofsky Performance Status (KPS) score ≥60, or Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- 6. Adequate venous access for peripheral blood mononuclear cell (PBMC) collection.
- 7. Left ventricular ejection fraction (LVEF) ≥40% by cardiac ultrasound within one month prior to screening.
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- 8. Resting oxygen saturation ≥95% while breathing room air. 9. Laboratory tests must meet the following criteria within the specified timeframe prior to screening:
- Hematological Function: Absolute neutrophil count (ANC)≥1.5×10^9/L, hemoglobin ≥90 g/L, platelet count≥100×10^9/L, absolute lymphocyte count≥0.15×10^9/L. No transfusion,granulocyte (macrophage)colony-stimulating factor, recombinant human erythropoietin, recombinant human thrombopoietin, thrombopoietin receptor agonist, recombinant human interleukin-11, or other supportive therapy within 14 days prior to the test.
- Liver Function: Total bilirubin≤1.5×upper limit of normal (ULN) (except for patients with Gilbert's syndrome characterized by persistent or recurrent unconjugated hyperbilirubinemia in the absence of hemolysis or hepatic pathology); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤2.5×ULN.
- Renal Function: Serum creatinine ≤1.5×ULN.
- Coagulation: Prothrombin time (PT) or activated partial thromboplastin time (aPTT) or international normalized ratio (INR) ≤1.5 ×ULN, in the absence of therapeutic anticoagulation.
- 10. Female subjects of childbearing potential must have a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required. Female subjects of childbearing potential must use highly effective contraception from the start of the trial until 6 months after the last dose of study treatment. Sexually active males, who have not undergone vasectomy, must agree to use barrier contraception from the start of the trial until 6 months after the last dose of study treatment.
Who cannot join
- Subjects with a known history of severe allergy to any component of the investigational product.
- Pregnant or lactating women. Body weight <40 kg.
- Viral Infections:
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- Seropositivity for HIV antibody or positive serological test for Treponema pallidum (syphilis).
- Hepatitis B surface antigen (HBsAg) positivity with peripheral blood HBV DNA levels above the upper limit of normal.
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- Hepatitis C virus (HCV) antibody positivity with detectable peripheral blood HCV RNA.
- Medical History and Concurrent Conditions:
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- Having undergone carmustine wafer implantation surgery within the past 6 months.
- Known or suspected active autoimmune diseases, including but not limited to Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.
- Current requirement for systemic immunosuppressive therapy or, in the investigator's judgment, a need for long-term immunosuppressant use during the study period. Intermittent use of topical, inhaled, or intranasal corticosteroids is allowed.
- Uncontrolled psychiatric disorders. Or subjects with a medical or psychiatric history that, in the investigator's opinion, could increase the risk associated with study participation or administration of the study drug, or could interfere with the interpretation of results.
- Toxicities from prior anticancer therapy have not recovered to ≤ Grade 1 per CTCAE version 5.0 (except for alopecia and other events deemed tolerable by the investigator).
- Participation in another interventional clinical trial within the past 1 month.
- Prior treatment with any CAR-T therapy or other gene therapy.
- Any severe or poorly controlled medical condition that, in the investigator's opinion, may increase the risk associated with study participation or study drug administration, or impair the subject's ability to receive the investigational product. This includes, but is not limited to, cardiovascular/cerebrovascular diseases, renal insufficiency, pulmonary embolism, coagulopathy or requirement for long-term anticoagulation therapy, active or uncontrolled infection requiring systemic treatment.
- History or presence of other malignancies within the past 3 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ (e.g., cervical, bladder, breast).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-Label, Dose-Escalation, Multiple Administration, Exploratory Clinical Study to Evaluate the Safety, Tolerability, and Anti-tumor Activity of TH-CART-027 Cell Injection in Subjects With Recurrent or Progressive Grade 4 Glioma
This is an open-Label, dose-escalation, multiple administration, exploratory clinical study to evaluate the safety, tolerability, and anti-tumor activity of TH-CART-027 cell injection in subjects with recurrent or progressive grade 4 glioma
- Conditions
- R/R Grade 4 Glioma
- Being tested
- TH-CART-027
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TH-CART-027Drug
Multiple-dosing, intratumoral and/or intraventricular infusion
| Study group | Role | What they receive |
|---|---|---|
| TH-CART-027 | Experimental | mutliple-dosing, intratumoral and/or intraventricular infusion Receives: Drug: TH-CART-027 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety：Incidence of Dose Limiting Toxicity (DLT)
Limiting toxicity type, incidence, and severity of dose limiting toxicities (DLTs) within 28 days after the first TH-CART-027 infusion
Measured: 28 days after the first TH-CART-027 infusion
Safety：Incidence and severity of adverse events (AEs)
To evaluate possible adverse events after TH-CAPT-027 infusion, including the incidence and severity of AEs.
Measured: Six months post CAR-T cells infusion.
Secondary outcomes (4)
Overall survival (OS)
Time from treatment initiation to death from any cause.
Measured: 12 and 24 months post CAR-T cells infusion
Objective response rate (ORR)
The assessment will be based on the investigator's evaluation of imaging evaluations, with efficacy evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). ORR refers to the proportion of patients with objective evidence of achieving a Complete Response (CR) or Partial Response (PR). Where applicable, responses recorded after disease progression or initiation of non-investigational anticancer therapy will be excluded
Measured: 3 months post CAR-T cells infusion
Progression Free Survival (PFS)
Defined as the time from initiation of the investigational drug to the first occurrence of progressive disease (PD) or death from any cause in the absence of documented PD. If no tumor progression is observed and the subject does not die during the study period, the analysis cutoff date will be determined as the date of the last tumor assessment
Measured: 1 year post CAR-T cells infusion
Disease Control Rate (DCR)
Defined as the proportion of patients achieving Partial Response (PR), Complete Response (CR), or Stable Disease (SD) according to RECIST 1.1 criteria, relative to the total number of cases in the study
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.
- First posted3 Feb 2026
- Study start30 Jan 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for R/R Grade 4 GliomaStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Luo, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384390
- Sponsor's protocol ID
- 2025IIT-C0019
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose-Escalation, Multiple Administration, Exploratory Clinical Study to Evaluate the Safety, Tolerability, and Anti-tumor Activity of TH-CART-027 Cell Injection in Subjects With Recurrent or Progressive Grade 4 Glioma
- ClinicalTrials.gov ID
- NCT07384390
- Acronym / sponsor ID
- 2025IIT-C0019
- Conditions
- R/R Grade 4 Glioma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of MedicineUniversity, hospital or other
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 3 Feb 2026 (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-Label, dose-escalation, multiple administration, exploratory clinical study to evaluate the safety, tolerability, and anti-tumor activity of TH-CART-027 cell injection in subjects with recurrent or progressive grade 4 glioma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TH-CART-027 | Experimental | Drug: TH-CART-027mutliple-dosing, intratumoral and/or intraventricular infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Voluntarily participate in the clinical trial; fully understand and are informed about this study and sign the informed consent form; willing and able to comply with and complete all trial procedures.
- 2. Male or female patients aged ≥18 years and ≤75 years. 3. Disease Status: Diagnosis of Grade 4 glioma as defined by the 2021 WHO Classification of Tumors of the Central Nervous System, including but not limited to glioblastoma, Grade 4 astrocytoma, and diffuse hemispheric glioma. Subjects must have experienced relapse or progression following standard therapy and are unsuitable for or refuse further surgical resection. Subjects with specific genetic mutations (e.g., NTRK gene fusion or BRAF V600E mutation) must have progressed after receiving corresponding targeted therapy to be eligible. Documentation of relapse/progression must include imaging (MRI or PET) or histopathological confirmation.
- 4. B7-H3 Expression: ≥30% positivity for B7-H3 molecule in primary/relapsed tumor tissue by pathological testing. B7-H3 positivity is defined as: the percentage of B7-H3-positive tumor cells among total viable tumor cells in non-necrotic tumor tissue areas ≥30%.
- 5. Karnofsky Performance Status (KPS) score ≥60, or Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- 6. Adequate venous access for peripheral blood mononuclear cell (PBMC) collection.
Key exclusion criteria (18 listed)
- Subjects with a known history of severe allergy to any component of the investigational product.
- Pregnant or lactating women. Body weight <40 kg.
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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 |
|---|---|---|
| TH-CART-027Multiple-dosing, intratumoral and/or intraventricular infusion | Drug | TH-CART-027 |
Primary outcome
Safety：Incidence of Dose Limiting Toxicity (DLT)
Time frame: 28 days after the first TH-CART-027 infusion
Limiting toxicity type, incidence, and severity of dose limiting toxicities (DLTs) within 28 days after the first TH-CART-027 infusion
Safety：Incidence and severity of adverse events (AEs)
Time frame: Six months post CAR-T cells infusion.
To evaluate possible adverse events after TH-CAPT-027 infusion, including the incidence and severity of AEs.
4 secondary outcomes
Overall survival (OS)
Time frame: 12 and 24 months post CAR-T cells infusion
Objective response rate (ORR)
Time frame: 3 months post CAR-T cells infusion
Progression Free Survival (PFS)
Time frame: 1 year post CAR-T cells infusion
Disease Control Rate (DCR)
Time frame: 1 year post CAR-T cells infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing TH-CART-027 in people with R/R Grade 4 Glioma, run by Shanghai Tongji Hospital, Tongji University School of Medicine.
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 12 inclusion and 18 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: opening soon, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Feng Chen Dr., PhD (+86 21-66111652, ndrchen@163.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 TH-CART-027 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?
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 4 Feb 2026.