Actively Recruiting
Safety and Efficacy of CMD03 CAR T Cell in Children With Relapse or Refractory Solid Tumors
Led by Chulalongkorn University · Updated on 2026-03-02
9
Participants Needed
1
Research Sites
191 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-cells with IL-7Ra signal targeting B7H3 in children with solid tumors patients after complete standard treatments.
CONDITIONS
Official Title
Safety and Efficacy of CMD03 CAR T Cell in Children With Relapse or Refractory Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have B7-H3 positive solid tumor with measurable disease.
- Evidence of relapsed or refractory disease after standard first-line therapy.
- Age between 1 and 25 years.
- Male or female.
- Performance status (Lansky or Karnofsky score) of 50 or higher.
- Life expectancy of at least 12 weeks.
- Normal organ function including AST, ALT, total bilirubin, creatinine within specified limits and oxygen saturation (SpO2) at room air of at least 90%.
- Prior therapy washout periods met before leukapheresis: at least 7 days after last chemotherapy/biologic therapy, 3 half-lives or 30 days after last antitumor antibody therapy, and at least 30 days after most recent cellular infusion.
- Stable or decreasing corticosteroid use within 1 week prior to enrollment, with a maximum dose of 0.5 mg/kg/day methylprednisolone.
- Ability to understand and willingness to sign informed consent or assent document.
You will not qualify if you...
- Grade 3 or higher cardiac dysfunction or symptomatic arrhythmia requiring intervention.
- Primary immunodeficiency or bone marrow failure syndrome.
- Uncontrolled illnesses such as active infections, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, pulmonary abnormalities, or psychiatric/social conditions limiting compliance.
- Pregnant or breastfeeding women; women of childbearing potential must have negative pregnancy test and agree to birth control during and for 4 months after treatment.
- Positive active HIV, hepatitis B, or hepatitis C infection; participants positive for hepatitis B or C antibodies must have negative PCR prior to enrollment.
AI-Screening
AI-Powered 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, Associate Professor, 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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