OncoMatch/Clinical Trials/NCT06482905
Safety and Efficacy Study of TX103 CAR-T Cell Therapy for Recurrent or Progressive Grade 4 Glioma.
Is NCT06482905 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) for high-grade glioma.
Treatment: Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Glioblastoma
Biomarker criteria
Required: B7H3 overexpression (≥30% tumor cells by IHC)
Subjects with confirmed B7-H3 positive (≥30%) tumor expression by immunohistochemistry (IHC) in either primary or recurrent tumor tissue
Allowed: NTRK1 fusion
For subjects harboring specific gene mutations, such as NTRK gene fusion ... they must have also progressed on corresponding mutation-directed therapies before enrollment
Allowed: NTRK2 fusion
For subjects harboring specific gene mutations, such as NTRK gene fusion ... they must have also progressed on corresponding mutation-directed therapies before enrollment
Allowed: NTRK3 fusion
For subjects harboring specific gene mutations, such as NTRK gene fusion ... they must have also progressed on corresponding mutation-directed therapies before enrollment
Allowed: BRAF V600E
For subjects harboring specific gene mutations, such as ... BRAF V600E mutation, they must have also progressed on corresponding mutation-directed therapies before enrollment
Disease stage
Required: Stage IV (WHO CNS 2021)
Grade: 4 (WHO CNS 2021)
grade 4 glioma, such as glioblastoma, grade 4 astrocytoma, diffuse hemispheric glioma, according to 2021 WHO Classification of Tumors of the CNS
Demographics
Prior therapy
Must have received: Stupp regimen (radiotherapy, temozolomide) — combined
disease recurrence or progression after surgery combined with Stupp regimen (concurrent radiotherapy and temozolomide (TMZ) followed by adjuvant TMZ)
Cannot have received: carmustine extended-release implantation (carmustine)
Exception: allowed if >6 months prior
Subjects who have received carmustine extended-release implantation surgery within 6 months
Cannot have received: CAR-T cell therapy
Subjects who have previously received CAR-T cell therapy or other gene therapy
Cannot have received: gene therapy
Subjects who have previously received CAR-T cell therapy or other gene therapy
Lab requirements
Blood counts
ANC ≥1.5×10^9/L, Hb ≥90g/L, PLT ≥100×10^9/L, ALC ≥0.15×10^9/L; no blood transfusion, G(M)-CSF, erythropoietin, thrombopoietin, platelet receptor agonist, or IL-11 within 14 days before test
Kidney function
serum creatinine ≤1.5×ULN
Liver function
Total bilirubin ≤ 1.5 × ULN (except Gilbert's syndrome); ALT and AST ≤2.5×ULN
Cardiac function
LVEF ≥ 40% within one month prior to first dose
adequate organ function, as indicated by laboratory test results that meet the following criteria: Hematological function: ANC ≥1.5×10^9/L, hemoglobin (Hb) ≥90g/L, platelet count (PLT) ≥100×10^9/L, absolute lymphocytes count (ALC) ≥0.15×10^9/L. ... Liver function: Total bilirubin (TBIL) ≤ 1.5 × ULN, ... ALT and AST ≤2.5×ULN. Renal function: serum creatinine (Scr) ≤1.5×ULN. ... LVEF ≥ 40% within one month prior to the first dose.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Arizona · Phoenix, Arizona
- Mayo Clinic in Florida · Jacksonville, Florida
- Mayo Clinic in Rochester · Rochester, Minnesota
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06482905 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior carmustine extended-release implantation, CAR-T cell therapy, gene therapy disqualifies patients from enrollment.
Does this trial require B7H3?
Yes, B7H3 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages