Actively Recruiting
Safety and Efficacy Study of TX103 CAR-T Cell Therapy for Recurrent or Progressive Grade 4 Glioma.
Led by Tcelltech Inc. · Updated on 2026-03-24
52
Participants Needed
4
Research Sites
142 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
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.
CONDITIONS
Official 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...
- Voluntarily agree to participate and sign informed consent
- Male or female aged 18 to 75 years
- Histologically confirmed Grade 4 glioma with recurrence or progression after surgery and Stupp regimen
- Disease recurrence or progression confirmed by radiographic or histopathological diagnosis
- Tumor with B7-H3 expression of 30% or higher by immunohistochemistry
- Karnofsky Performance Score of 60 or higher
- Adequate venous access for peripheral blood mononuclear cell collection
- Left ventricular ejection fraction of 40% or higher within one month before dosing
- Oxygen saturation of 95% or higher at rest
- Adequate organ function as indicated by specified laboratory test criteria
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening
- Women of childbearing potential and sexually active males must agree to use reliable contraception during the study and for 6 months after last dose
You will not qualify if you...
- Pregnant or breastfeeding females
- Positive for HIV antibody, syphilis serology, or active hepatitis B or C infection
- Received carmustine extended-release implantation surgery within 6 months
- Active autoimmune diseases or needing systemic immunosuppressive therapy (except certain glucocorticoid therapies)
- Uncontrolled mental disorders or history that increases study risks or interferes with results
- Unresolved toxicities from prior treatments above grade 1 except alopecia and tolerable events
- Participation in other interventional clinical trials within the past month
- Previous CAR-T cell or gene therapy
- Serious or poorly controlled diseases that increase risk or affect study drug administration
- Other malignant tumors within past 3 years except non-melanoma skin cancer or carcinoma in situ
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
X
Xianzhen Chen, MM
CONTACT
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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