Prodigy huCART19

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CAR T cell therapy has shifted the treatment landscape for pediatric and young adult patients with advanced B-cell leukemias. However, the manufacturing process remains in its first generation: difficult, time-consuming, and not automated. The time and significant resources in this process can result in patient safety issues - with patients growing sicker, with harder to control leukemias - in the waiting period. Use of the CliniMACS Prodigy platform can help to surmount these issues. This study will determine the safety and usefulness of using the CliniMACS Prodigy platform to manufacture huCART19 cells.

This is a Phase 1/2b trial for the treatment of patients with either advanced or refractory B cell Acute Lymphoblastic Leukemia or B-lineage lymphoblastic lymphoma who will be treated with huCART19, which has been manufactured using the CliniMACs Prodigy Platform. Possible procedures include medical record review, apheresis, huCART19 infusion, blood draws, physical exams, imaging, and disease assessments through bone marrows and lumbar punctures. Overall, approximately 89 subjects will be enrolled on this clinical trial.

Who Do I Contact?

If you are interested in participating in the study or want to learn more please contact our study team at oncointake [at] chop.edu or 845-553-5358.

Eligibility & Criteria

IRB #:
22-019978
Official Title:
Phase 1/2b Trial of Autologous Humanized CD19-Directed Chimeric Antigen Receptor T-Cells (huCART19) Manufactured using the CliniMACS Prodigy Platform for the Treatment of Pediatric B cell Acute Lymphoblastic Leukemia (B-ALL)
Study Phase:
Phase I
Phase II
Eligible Age Range:
0 - 29 Years
Gender:
All
Study Categories:

Visit Criteria

The study is currently enrolling and accepting new patients.