CAR-T cell therapy for children with relapsed leukemia or lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of CAR-T cell therapy targeting the CD19 antigen in pediatric patients with relapsed or refractory acute lymphoblastic leukemia (ALL) or lymphoma. Participants will receive autologous T cells modified to express a chimeric antigen receptor after undergoing a chemotherapy lymphodepletion regimen. The study aims to validate the safety profile of this treatment and assess the response rates in the targeted patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hong Kong Children's Hospital
  Hong Kong, Hong Kong Recruiting

Study contacts

• Principal investigator: Pamela Lee, MD — The University of Hong Kong
• Study coordinator: Daniel Cheuk, MBBS
• Email: cheukkld@ha.org.hk
• Phone: 852-35136049

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• CAR-T Cell Therapy for B-ALL (relapsed/refractory)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.