What is CD19-IL7Ra CAR T-cell therapy studying for children with relapsed B-cell Acute Lymphoblastic Leukemia?

This clinical trial is studying how safe and potentially effective CD19-IL7Ra CAR T-cell therapy is for children with relapsed or refractory B-cell Acute Lymphoblastic Leukemia. Researchers are evaluating if genetically modified T cells can better control the leukemia after standard treatments have not been successful. The study is sponsored by Chulalongkorn University and aims to provide new treatment options for these patients.

Who may be eligible for this relapsed B-cell Acute Lymphoblastic Leukemia clinical trial?

Children aged 1 to 18 years with relapsed or refractory B-cell Acute Lymphoblastic Leukemia that is CD19 positive may be eligible. Both males and females can join if they have a good performance status and normal organ function. Patients must have completed prior therapies and be willing to sign consent. Please review eligibility criteria for more details.

Is there any cost to participate in this relapsed B-cell Acute Lymphoblastic Leukemia clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for their own travel needs.

Actively Recruiting

Phase 1

Age: 1Year - 18Years

All Genders

ID07078929

Safety and Preliminary Efficacy of CD19 With IL-7 Receptor Alpha Signaling CAR T Cell Therapy in Pediatric Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

Led by Chulalongkorn University · Updated on 2026-03-02

Participants Needed

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and early effectiveness of a new treatment called CD19-IL7Ra CAR T-cell therapy in children with relapsed or refractory B-cell Acute Lymphoblastic Leukemia ALL who have already undergone standard treatments. This trial addresses the urgent need for new options since patients with relapsed or refractory disease have very limited chances of remission and survival with current therapies. This research is the first to study this treatment in Thai pediatric patients and aims to improve response rates and survival. The study involves giving participants their own T cells that have been genetically modified to target leukemia cells by recognizing the CD19 protein and including IL-7 receptor alpha signaling. The CAR T cells are administered through a central venous catheter after a preparative treatment called lymphodepletion. Two dose levels of the CAR T cells will be tested 0.5 million cellskg and 1 million cellskg. This is a Phase 1 trial focused on safety and preliminary efficacy. Participants will be monitored closely for adverse events at several time points up to 12 months after the CAR T-cell infusion. Researchers will also evaluate the overall response rate of leukemia at multiple intervals during the year following treatment. Assessments include clinical exams, laboratory tests, and disease evaluations. The total duration of follow-up is up to one year to track safety and treatment outcomes.

CONDITIONS

Brief Title

Clinical Trial of CMD63 Chimeric Antigen Receptor T-cell (CAR T-cell) in Children With Acute Lymphoblastic Leukemia (ALL)

Who Can Participate

Age: 1Year - 18Years

All Genders

Eligibility Criteria

You may qualify if you...

Have relapsed or refractory B-cell Acute Lymphoblastic Leukemia treated with at least one therapy line
Disease must be CD19 positive by immunohistochemistry or flow cytometry
Age between 1 and 18 years
Male or female sex
Lansky or Karnofsky performance score of 50 or higher
Normal organ function including AST, ALT, bilirubin, creatinine within specified limits
Completed prior therapy washout periods as specified
Ability to understand and willingness to sign informed consent

You will not qualify if you...

Active Graft Versus Host Disease requiring systemic immunosuppressant within 4 weeks
History of active malignancy other than non-melanoma skin cancer or carcinoma in situ
Uncontrolled illness such as active infection, heart failure, unstable angina, arrhythmia, pulmonary issues, psychiatric illness, or social issues limiting compliance
Pregnant or breastfeeding women; must have negative pregnancy test and agree to birth control
Evidence of myelodysplasia on bone marrow biopsy
Active HIV, hepatitis B or C infection without negative PCR confirmation
History of anaphylactic reaction to albumin

Research Team

Piti Techavichit, Associate Professor, MD

Koramit Suppipat, MD

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