CD-19 CAR-T Cell for Pediatric ALL or Lymphoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-17
SponsorHong Kong Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
CAR-T
Biological/VaccineCAR-T cell (CHXCART01) infusion intravenously once at a dose of 0.2-2 million cells/kg recipient body weight
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: CAR-T cell therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1 month for subjects with ALL, and 3 months for subjects with lymphoma2
Incidence and severity of adverse events
Severity of adverse events are graded according to CTCAEv5.0.
Time frame
through study completion, an average of 6 monthsSecondary outcomes
1
Frequency of minimal residual disease for ALL
Measurable residual disease in bone marrow by flow cytometry or PCR methods.
Time frame
1 month2
Overall survival
survival as estimated by Kaplan-Meier method. Death from any cause is considered as event for analysis.
Time frame
1 year3
Event-free survival
Event-free survival as estimated by Kaplan-Meier method. Events are death from any cause, or relapse or progression of underlying disease.
Time frame
1 year4
Proportion of products successfully manufactured
Success defined as meeting product release criteria with at least 0.2 million cells/kg recipient body weight
Time frame
at the time of CAR-T cell infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov