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 (May 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
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
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 →
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