Menu
Recruiting NCT06866873

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

No phase Interventional Lymphoma, B-Cell Acute Lymphoblastic Leukemia, Pediatric

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CAR-T.
Who it may be relevant to
Registry conditions: Lymphoma, B-Cell, Acute Lymphoblastic Leukemia, Pediatric. Basic parameters: 1 year — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Safety and Feasibility Study of CD19 Chimeric Antigen Receptor (CAR) T Cells in Children with Relapsed or Refractory CD19 Positive Acute Lymphoblastic Leukemia or Lymphoma

Overview

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.

Interventions

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

Primary outcome measures

  • Complete response rate (CRR) for ALL and Overall response rate (ORR) for lymphoma [Time frame: 1 month for subjects with ALL, and 3 months for subjects with lymphoma]
  • Incidence and severity of adverse events [Time frame: through study completion, an average of 6 months]
Secondary outcome measures (4)
  • Frequency of minimal residual disease for ALL [Time frame: 1 month]
  • Overall survival [Time frame: 1 year]
  • Event-free survival [Time frame: 1 year]
  • Proportion of products successfully manufactured [Time frame: at the time of CAR-T cell infusion]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Hong Kong Children's Hospital — Hong Kong

Identifiers

NCT: NCT06866873 · HKCH-REC-2021-032

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗