CAR T-cell Therapy Tested in Children With Relapsed Leukemia
Tests modified immune cells against CD19 in children with returning acute lymphoblastic leukemia.
Plain-language title generated from the registry record
Registry title: Clinical Trial of CMD63 Chimeric Antigen Receptor T-cell (CAR T-cell) in Children With Acute Lymphoblastic Leukemia (ALL)
Key facts
- Where
- Bangkok and Chiang Mai, ThailandSee the 3 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 18 years old?
Source: NCT07078929, who can take part
Where in Thailand
- King Chulalongkorn Memorial HospitalBangkok, ThailandTaking people
- Siriraj HospitalBangkok, ThailandNot yet recruiting
- Maharaj Nakorn Chiang Mai HospitalChiang Mai, ThailandNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chulalongkorn University
- Trial code
- NCT07078929
- Record updated
- 2 March 2026
- Original description
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.Read full original descriptionShow less
Safety and Preliminary Efficacy of CD19 With IL-7 Receptor Alpha Signaling Chimeric Antigen Receptor T Cell (CMD63) in Relapse and Refractory Pediatric B-cell Acute Lymphoblastic Leukemia
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.
Inclusion: Participants must have relapsed, or refractory ALL treated with at least one lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve complete remission with the last regimen; Participant with Philadelphia Chromosome positive ALL are eligible if the progressed, had stable disease or relapsed after one line of therapy including tyrosine kinase inhibitors (TKIs); The participant's disease must be CD19 positive either by immunohistochemistry or flow cytometry analysis; Age 1 - 18 years; Sex: Male or Female; Performance status: Lansky or Karnofsky score greater than or equal to 50; Normal organ function:; AST (SGOT) less 5 times the upper limit of normal (ULN); ALT (SGPT) less 5 times the upper limit of normal (ULN); Total bilirubin less 3 times the upper limit of normal (ULN); Creatinine less 5 times the upper limit of normal (ULN); SpO2 room air greater than or equal to 90%; Prior therapy wash-out before planned leukapheresis 7.1 Greater than or equal to 7 days post last chemotherapy/biologic therapy administration 7.2 Three half-lives or 30 days, whichever is shorter after the last dose of antitumor antibody therapy 7.3 At least 30 days from most recent cellular infusion 7.4 All systemically administered corticosteroid treatment therapy must be stable or decreasing within 1 week prior to enrollment with a maximum of 0.5 mg/day dose of methylprednisolone. Corticosteroid physiologic replacement therapy is allowed; Participants and/or care givers must have the ability to understand and willingness to sign a written informed consent document.
Exclusion: Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy; Serologic status reflecting active HIV, hepatitis B or C infection. Participants that are positive for hepatitis B core antibody, hepatitis B surface antigen or hepatitis C antibody must have negative PCR prior to enrollment; History of active malignancy other than non-melanoma skin cancer and carcinoma in situ (e.g. cervix, bladder, breast); Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities, Graft Versus Host Disease or psychiatric illness/social situations that would limit compliance with study requirements; Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with potential for teratogenic or abortifacient effect. Women of child bearing potential must have negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of mother with CAR-T cells, breast feeding should be discontinued. These potential risks may also apply to other agents used in this study. Participants of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving CAR-T cell infusion; Participants who have a history of anaphylactic reaction to albumin; Active GVHD that required systemic immunosuppressant with 4 weeks of enrollment.