HuCART19 Prodigy for Pediatric B-ALL
This study is looking at a new way to make a type of cell therapy called autologous humanized CD19-Directed Chimeric Antigen Receptor T-Cells (huCART19) for children and young adults with B cell Acute Lymphoblastic Leukemia (B-ALL) or B Lineage Lymphoblastic Lymphoma. This therapy uses your own T-cells, which are a type of immune cell, to fight cancer. The study is testing if a new manufacturing process, using the CliniMACS Prodigy platform, is safe and effective. This new process aims to make the huCART19 cells faster and more efficiently. We want to enroll 115 participants between 0 and 29 years old who have CD19+ ALL or Lly that has come back or not responded to previous treatments. The study will follow participants for 5 years to see how safe and effective the treatment is. The current status of the study is unclear.
- Study design
- This is an interventional study with a planned enrollment of 115 participants. It is not specified if it is randomized or blinded.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 5 years to measure the safety and effectiveness of the huCART19 administration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Autologous HuCART19 T Cells Manufactured Using the CliniMACS Prodigy Platform for Pediatric B-ALL (huCART19 Prodigy)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Allison Barz Leahy, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia
- Stephan Grupp, MD,PhD · STUDY_DIRECTOR · Children's Hospital of Philadelphia
Who to contact
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What this trial measures
- Safety of huCART19 Administration5 years
The safety of the administering Humanized Cd19-Directed Chimeric Antigen Receptor T-Cells (huCART9) will be measured by the monitoring the frequency and severity of adverse events in patients with advanced or refractory CD19+ hematologic malignancies, including those previously treated with cell therapy.
- Efficacy of huCART19 Administration5 years
The efficacy of huCART9 will be measured by the evaluating the overall response rate in patients with advanced or refractory CD19+ hematologic malignancies, including those previously treated with cell therapy.