Actively Recruiting
Safety and Efficacy of Loco-regional B7H3 IL-7Ra CAR T Cell in DIPG
Led by Chulalongkorn University · Updated on 2025-03-30
9
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
C
Chulalongkorn University
Lead Sponsor
K
King Chulalongkorn Memorial Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Phase 1 clinical trial to evaluate the safety and early efficacy of CAR T-cell with IL-7Ra signal targeting B7H3 in children with diffuse intrinsic pontine glioma (DIPG) patients after complete standard treatments.
CONDITIONS
Official Title
Safety and Efficacy of Loco-regional B7H3 IL-7Ra CAR T Cell in DIPG
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of diffuse intrinsic pontine glioma (DIPG) at any time after completing standard radiotherapy
- Age between 1 and 18 years
- Male or female sex
- Presence of a central nervous system reservoir catheter (e.g., Ommaya or Rickham catheter) correctly positioned for CNS therapy
- Performance status with Lansky or Karnofsky score of 60 or higher
- Life expectancy of at least 8 weeks
- Normal organ function including: AST and ALT less than 5 times upper limit of normal, total bilirubin less than 3 times upper limit of normal, creatinine less than 5 times upper limit of normal, and oxygen saturation at room air at least 90%
- Appropriate wash-out period since last therapy before leukapheresis: at least 7 days after chemotherapy/biologic therapy, 3 half-lives or 30 days after antitumor antibody therapy, at least 30 days after most recent cellular infusion
- Corticosteroid treatment stable or decreasing within 1 week prior to enrollment, with dexamethasone dose not exceeding 2.5 mg/m2/day (physiologic replacement allowed)
- Ability of participant or legal guardian to understand and sign informed consent or assent
You will not qualify if you...
- Grade 3 or higher cardiac dysfunction or symptomatic arrhythmia needing intervention
- Primary immunodeficiency or bone marrow failure syndrome
- Clinical or radiographic signs of impending central nervous system herniation
- Grade 3 or higher difficulty swallowing (dysphagia)
- History of active cancer other than nonmelanoma skin cancer or carcinoma in situ
- Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, lung problems, or psychiatric/social issues limiting study participation
- Pregnancy or breastfeeding; women of childbearing potential must have negative pregnancy test and agree to use birth control during and for 4 months after treatment
- Positive active infection with HIV, hepatitis B or C; those positive for hepatitis B or C antibodies must have negative PCR test before enrollment
AI-Screening
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Trial Site Locations
Total: 1 location
1
King Chulalongkorn Memorial Hospital
Bangkok, Pathumwan, Thailand, 10330
Actively Recruiting
Research Team
P
Piti Techavichit, MD
CONTACT
K
Koramit Suppipat, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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