Safety and Efficacy Study of TX103 CAR-T Cell Therapy for Grade 4 Glioma
This study is testing a new treatment called TX103 CAR-T cell therapy for people with recurrent or progressive Grade 4 glioma (a type of aggressive brain tumor). Researchers want to see how safe TX103 is and if it can help fight the tumor. They will also try to find the best dose. You might be able to join if you are 18 to 75 years old and have a confirmed diagnosis of Grade 4 glioma. The study will look at how many serious side effects occur within 28 days of the first treatment and how many side effects overall happen within six months. This study is currently recruiting 52 participants.
- Study design
- This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It uses a dose-escalation design with 52 planned participants to find the safest and most effective dose.
- What's involved
- Eligible participants will receive two infusions of TX103 within a 21-day treatment cycle. The study involves a 14-day observation period after each infusion.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for at least six months after the CAR-T cell infusion.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06482905
Safety and Efficacy Study of TX103 CAR-T Cell Therapy for Recurrent or Progressive Grade 4 Glioma.
Recruiting
PHASE1Ages 18–75InterventionalTreatmentTcelltech Inc.
~52 participants
Updated 2026-03-24 on ClinicalTrials.gov
What's tested:Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103
At a glance
Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety：Incidence of Dose Limiting Toxicity (DLT)
Measured over 28 days after the first TX103 infusion.
+1 more outcome measured
Conditions
Where it's being run
4 sites across 4 statesArizona1
Florida1
Minnesota1
Beijing Municipality1
Study leadership
- Gangxiong Huang, MD · STUDY_DIRECTOR · Tcelltech Inc.
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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. 10. 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.
Exclusion
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. 3. Medical history and concomitant diseases:
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).
What this trial measures
- Safety：Incidence of Dose Limiting Toxicity (DLT)28 days after the first TX103 infusion.
Type, incidence, and severity of dose limiting toxicities (DLTs) within 28 days after the first TX103 infusion.
- Safety：Incidence and severity of adverse events (AEs)six months post CAR-T cells infusion.
To evaluate the possible adverse events after TX103 infusion, including the incidence, and severity of AEs.