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

NCT06866873 | Recruiting

• 1 other identifier: HKCH-REC-2021-032
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Keywords

CAR-T cell; Pediatric

Outcome Measures

Primary Outcomes (2)

• Complete response rate (CRR) for ALL and Overall response rate (ORR) for lymphoma

  Complete response for ALL was defined as leukemic cells \<5% in bone marrow. Overall response for lymphoma was defined as complete response plus partial response defined by Lugano criteria.

  1 month for subjects with ALL, and 3 months for subjects with lymphoma

• Incidence and severity of adverse events

  Severity of adverse events are graded according to CTCAEv5.0.

  through study completion, an average of 6 months

Secondary Outcomes (4)

• Frequency of minimal residual disease for ALL

  1 month

• Overall survival

  1 year

• Event-free survival

  1 year

• Proportion of products successfully manufactured

  at the time of CAR-T cell infusion

Study Arms (1)

CAR-T cell therapy

EXPERIMENTAL

CAR-T cell infusion intravenously once

Biological: CAR-T

Interventions

CAR-T BIOLOGICAL

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

CAR-T cell therapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hong Kong Children's Hospital: lead

Study Sites (1)

Hong Kong Children's Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Study Officials

• Pamela Lee, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Cheuk, MBBS

CONTACT

852-35136049; cheukkld@ha.org.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 10, 2025
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 31, 2037
• Study Completion (Estimated): December 31, 2037
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

HK (1)