Actively Recruiting
Clinical Trial of CMD63 Chimeric Antigen Receptor T-cell (CAR T-cell) in Children With Acute Lymphoblastic Leukemia (ALL)
Led by Chulalongkorn University · Updated on 2026-03-02
16
Participants Needed
3
Research Sites
139 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 Chimeric Antigen Receptor T-cell (CAR T-cell) with IL-7Rα signaling targeting CD19 in children with relapsed and refractory B-cell Acute Lymphoblastic Leukemia (ALL) after complete standard treatments.
CONDITIONS
Official Title
Clinical Trial of CMD63 Chimeric Antigen Receptor T-cell (CAR T-cell) in Children With Acute Lymphoblastic Leukemia (ALL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 1 to 18 years
- Diagnosis of relapsed or refractory B-cell Acute Lymphoblastic Leukemia
- Disease must be CD19 positive by immunohistochemistry or flow cytometry
- Male or female participants
- Lansky or Karnofsky performance score of 50 or higher
- Normal organ function with AST and ALT less than 5 times upper normal limit
- Total bilirubin less than 3 times upper normal limit
- Creatinine less than 5 times upper normal limit
- Oxygen saturation (SpO2) on room air 90% or higher
- At least 7 days since last chemotherapy or biologic therapy
- At least 30 days since last cellular infusion
- Stable or decreasing corticosteroid use with methylprednisolone dose up to 0.5 mg/day
- Ability to understand and sign informed consent
You will not qualify if you...
- Active graft-versus-host disease requiring systemic immunosuppressants within 4 weeks
- History of active malignancy other than non-melanoma skin cancer or carcinoma in situ
- Uncontrolled illnesses such as active infection, heart failure, unstable angina, arrhythmia, pulmonary issues, psychiatric illness, or social situations limiting study compliance
- Pregnant or breastfeeding females
- Positive pregnancy test for women of childbearing potential
- Inability or unwillingness to use birth control during and for 4 months after treatment
- Evidence of myelodysplasia or related cytogenetic abnormalities
- Active HIV, hepatitis B or C infection without negative PCR confirmation
- History of severe allergic reaction to albumin
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Siriraj Hospital
Bangkok, Bangkoknoi, Thailand, 10700
Not Yet Recruiting
2
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Mueang Chiang Mai District, Thailand, 50200
Not Yet Recruiting
3
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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