CD-19 CAR-T Cell for Pediatric ALL or Lymphoma

NCT ID: NCT06866873

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2037-12-31

Brief Summary

This study seeks to examine the efficacy and safety of the administration of autologous T cells that have been modified through the introduction of a chimeric antigen receptor (CAR) targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in children with relapsed or refractory acute lymphoblastic leukemia (ALL) or lymphoma. The overall goal of this study is to validate the safety profile of administration CD19-CAR T cells and describe the response rate in children with relapsed/refractory ALL or lymphoma.

Conditions

Lymphoma, B-Cell; Acute Lymphoblastic Leukemia, Pediatric

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CAR-T cell therapy

CAR-T cell infusion intravenously once

Group Type: EXPERIMENTAL

CAR-T

Intervention Type: BIOLOGICAL

CAR-T cell (CHXCART01) infusion intravenously once at a dose of 0.2-2 million cells/kg recipient body weight

Interventions

CAR-T

CAR-T cell (CHXCART01) infusion intravenously once at a dose of 0.2-2 million cells/kg recipient body weight

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects must have relapsed or refractory ALL or lymphoma treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve partial or complete remission with the last regimen.
• The patient's disease must be CD19 positive, either by immunohistochemistry or flow cytometry analysis on the last biopsy available.
• Age 1-17 years.
• Performance status: Subjects > 10 years of age: Karnofsky ≥ 50%; Subjects ≤ 10 years of age: Lansky scale ≥ 50%.
• Normal organ function.

• Total bilirubin ≤ 3 times upper limit of normal
• AST (SGOT) ≤ 5 times upper limit of normal
• ALT (SGPT) ≤ 5 times upper limit of normal
• Serum Creatinine ≤ 2 times upper limit of normal
• Subjects must have the following hematologic function parameters: Hemoglobin (Hb) level > 8 g/dL; Absolute Lymphocyte Count > 0.1x10^9/L; Platelet > 50x10^9/L
• Prior therapy wash-out. At least 2 weeks or 5 half lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis.
• Subjects' parent or legal guardian must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

• Autologous transplant within 6 weeks of planned CAR T cell infusion.
• Recipient of CAR-T cell therapy outside of this protocol.
• Active central nervous system (CNS) or meningeal involvement by tumor.
• History of additional active malignancy other than non-melanoma skin cancer, carcinoma in situ (e.g. cervix, bladder, breast).
• Active human immunodeficiency virus (HIV) infection.
• Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant or breastfeeding women.
• Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy.
• Serologic status reflecting active hepatitis B or C infection.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hong Kong Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cheuk Ka Leung Daniel

Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pamela Lee, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Hong Kong Children's Hospital

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Daniel Cheuk, MBBS

Role: CONTACT

cheukkld@ha.org.hk

852-35136049

Facility Contacts

Daniel Cheuk, MBBS

Role: primary

cheukkld@ha.org.hk

852-35136049

Other Identifiers

HKCH-REC-2021-032

Identifier Type: -

Identifier Source: org_study_id