Actively Recruiting
Safety and Tolerability Study of TX103 CAR-T Cell Therapy for Recurrent or Progressive Grade 4 Glioma Using Dose-Escalation and Different Delivery Methods
Led by Tcelltech Inc. · Updated on 2026-03-24
52
Participants Needed
4
Research Sites
39 weeks
Total Duration
On this page
Sponsors
T
Tcelltech Inc.
Lead Sponsor
B
Beijing Tiantan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and antitumor activity of TX103, an anti-B7-H3 CAR-T cell injection, in adults with recurrent or progressive Grade 4 glioma, including glioblastoma and other high-grade brain tumors. This phase I, open-label study aims to find the maximum tolerated dose and recommend a dose for future studies. The trial is sponsored by Tcelltech Inc. and focuses on patients who have experienced disease progression after standard treatments.
CONDITIONS
Brief Title
Safety and Efficacy Study of TX103 CAR-T Cell Therapy for Recurrent or Progressive Grade 4 Glioma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must voluntarily agree and sign informed consent to participate.
- Male or female participants aged 18 to 75 years.
- Histologically confirmed Grade 4 glioma with disease recurrence or progression after surgery plus Stupp regimen.
- B7-H3 positive tumor expression of 30% or higher confirmed by immunohistochemistry.
- Karnofsky Performance Status (KPS) score of 60 or higher.
- Adequate venous access for blood collection.
- Left ventricular ejection fraction (LVEF) of 40% or higher within one month before dosing.
- Oxygen saturation of 95% or higher at rest.
- Adequate organ function meeting specified laboratory values.
- Women of childbearing potential must have negative pregnancy tests and agree to use reliable contraception; sexually active males must also agree to contraception use.
You will not qualify if you...
- Pregnant or breastfeeding women.
- Positive for HIV, active hepatitis B or C infection.
- Carmustine implantation surgery within past 6 months.
- Known or suspected active autoimmune diseases.
- Use of systemic immunosuppressive agents or need for long-term immunosuppression, except intermittent topical or inhaled steroids.
- Uncontrolled mental disorders or conditions increasing study risks.
- Unresolved toxicity greater than grade 1 from prior treatments.
- Participation in other interventional trials within past month.
- Previous CAR-T cell or gene therapy.
- Serious or uncontrolled diseases affecting safety or ability to receive study drug.
- Other malignant tumors within past 3 years except certain skin and in situ cancers.
- Requirement for long-term anticoagulation or conditions affecting coagulation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 21 days per treatment cycle
Participants receive TX103 CAR-T cell therapy via intraventricular or dual intracavitary and intraventricular delivery methods in two infusions per 21-day cycle, followed by a 14-day observation period each cycle.
2 infusion visits on Day 1 and Day 8, with observation through Day 21
Duration - Up to 1 year
Participants are monitored for safety and efficacy outcomes, including dose limiting toxicities and adverse events, for up to 6 months and longer-term survival and disease control for up to 1 year post infusion.
Periodic visits for safety and efficacy assessments up to 1 year
Trial Site Locations
Total: 4 locations
1
Mayo Clinic in Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
4
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
R
Rui Feng, MD
X
Xianzhen Chen, MM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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