NCT05241392Active, not recruitingPhase 1
Safety and Efficacy Study of Anti-B7-H3 CAR-T Cell Therapy for Recurrent Glioblastoma
An Open, Single-arm, Phase 1 Study to Evaluate the Safety/Preliminary Effectiveness and Determine the Maximal Tolerated Dose of B7-H3-targeting CAR-T Cell Therapy in Treating Recurrent Glioblastomas
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
This is an open-label, single-arm, dose-escalation and multiple-dose study to evaluate the safety, tolerability, and preliminary efficacy of TX103-CAR-T Cell Injection, a B7-H3-targeting chimeric antigen receptor T-cell (CAR-T) therapy, in patients with recurrent glioblastoma. The study also aims to explore the maximum tolerated dose (MTD) and determine the recommended Phase II dose (RP2D) of TX103-CAR-T Cell Injection.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 13 Jan 2022
- Start date
- 27 Jan 2022
- Primary completion date
- 30 Nov 2024
- Lead sponsor
- Beijing Tiantan Hospital
- Diseases
- Glioblastoma
- NCT number
- NCT05241392
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 27 Jan 2022 to the primary completion date, 30 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to bevacizumab；
- Within 5 days before the CAR-T cell infusion, subjects receiving systemic administration of steroids with dosage more than 10mg/d prednisone or the equivalent doses of other steroids ( not including inhaled corticosteroid)；
- Subjects receiving the placement of a carmustine slow-release wafer within 6 months before the enrollment;
- Receiving long-term immunosuppressive treatment after organ transplantation;
- Not recovered from the toxicities or side effects by previous treatment;
- Subjects who have participated the other interventional trial within one month before the enrollment, or have received other CAR-T cell therapies or gene-modified cell therapy before enrollment.
Other illness
- Comorbid with Other uncontrolled malignancy；
- Active immunodeficiency virus (HIV) or hepatitis B virus or hepatitis C virus or tuberculosis infection;
- Autoimmune diseases;
- Severe or uncontrolled psychiatric diseases or condition that could increase adverse events or interfere the evaluation of outcomes;
- Subjects with medical conditions that affect signing the written informed consent or complying with the research procedures, the medical conditions including, but not limited to cardio-cerebral vascular diseases, renal dysfunction/failure, pulmonary embolism, coagulation disorders, active systemic infection, uncontrolled infection et. al; or patients who are unwilling or unable to comply with the research procedures; these
- Subjects with other conditions that would interfere trial participation at the investigator's discretion.
Other
- Pregnant or breastfeeding females；
Who the study is looking for
- Male or female, aged 18-75 years (including 18 and 75 years old)；
- Patients with relapsed glioblastoma, as confirmed by positron emission tomography (PET) or histologic pathology；
- A \>= 30% staining extent of B7-H3 in his/her primary/recurrent tumor tissue by the immunochemical method;
- Karnofsky scale score\>=50
- Availability in collecting peripheral blood mononuclear cells (PBMCs) ；
- Adequate laboratory values and adequate organ function;
- Patients with childbearing/fathering potential must agree to use highly effective contraception；
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tiantan Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
Related publications
- Intracranial delivery of B7-H3-targeting CAR-T cells for recurrent glioblastoma: a phase 1 trial.Nat Med · 2026 · PMID 42562965
This page is information, not medical advice. Discuss any trial with your doctor.