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

NCT07078929 | Recruiting Phase 1 DMC

• 2 other identifiers: CMD63-ALL-2025Chulalongkorn University
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Relapse B Acute Lymphoblastic Leukemia; Refactory Childhood Acute Lymphoblastic Leukemia

Keywords

CAR T cell; CD19; IL-7 receptor alpha; Chimeric antigen receptor T cell; Adoptive cellular therapy; B-cell acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Adverse Events of CD19-IL7Ra CAR T-cells infusion in B-cell acute lymphoblastic leukemia patients.

  The incidence of adverse events assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0

  7 days, 14 days, 21 days, 30 days, 60 days, 90 days, 6 months and 12 months after CD19-IL7Ra CAR-T cell infusion

Secondary Outcomes (1)

• The overall response rate of B-cell acute lymphoblastic leukemia

  30 days, 60 days, 90 days, 6 months and 12 months after CD19-IL7Ra CAR-T cell infusion

Other Outcomes (2)

• Persistence of anti-CD19 CAR-T cell in peripheral blood

  7 days, 14 days, 21 days, 30 days, 60 days, 90 days, 6 months and 12 months after CD19-IL7Ra CAR-T cell infusion

• Serum cytokine level measurement

  7 days, 14 days, 21 days and 30 days after CD19-IL7Ra CAR-T cell infusion

Study Arms (1)

CD19 IL-7Ra CAR T cell in B-cell acute lymphoblastic leukemia

EXPERIMENTAL

CD19-specific chimeric antigen receptor (CAR) T cell with IL-7 receptor alpha signaling Dose level: 0.5x10e6 cells/kg, 1x10e6 cells/kg

Biological: CD19-IL7Ra CAR-T cells

Interventions

CD19-IL7Ra CAR-T cells BIOLOGICAL

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

CD19 IL-7Ra CAR T cell in B-cell acute lymphoblastic leukemia

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chulalongkorn University: lead
• King Chulalongkorn Memorial Hospital: collaborator

Study Sites (3)

Siriraj Hospital

Bangkok, Bangkoknoi, 10700, Thailand

NOT YET RECRUITING

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, Mueang Chiang Mai District, 50200, Thailand

NOT YET RECRUITING

King Chulalongkorn Memorial Hospital

Bangkok, Pathumwan, 10330, Thailand

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Kanhatai Chiengthong, MD

  King Chulalongkorn Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piti Techavichit, Associate Professor, MD

CONTACT

+66817515363; piti.t@chula.ac.th

Koramit Suppipat, MD

CONTACT

+66816282068; koramit.s@chula.ac.th

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3+3 dose escalation study

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 22, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 2, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (3)