RecruitingPhase 1NCT07078929
Clinical Trial of CMD63 Chimeric Antigen Receptor T-cell (CAR T-cell) in Children With Acute Lymphoblastic Leukemia (ALL)
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
Sponsor
Chulalongkorn University
Enrollment
16 participants
Start Date
Jan 1, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 1 YearMax Age: 18 Years
Inclusion Criteria14
- 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 Criteria7
- Active GVHD that required systemic immunosuppressant with 4 weeks of 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.
- 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.
- Participants who have a history of anaphylactic reaction to albumin.
Interventions
BIOLOGICALCD19-IL7Ra CAR-T cells
Autologous T cells lentiviral transduced to express a CD19-specific chimeric antigen receptor (CAR) with the addition of an IL-7 receptor alpha signaling domain, administered via central venous access catheter after lymphodepletion
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07078929