CAR T cell therapy has shifted the treatment landscape for pediatric and young adult patients with advanced B-cell leukemias. This study aims to treat patients with relapsed disease by administering two CART cell products, huCART19 and CART22-65s. The study will determine the safety and efficacy and usefulness of administering two CAR T cell products in patients with advanced B-cell leukemias.

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. 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 93 subjects will be enrolled on this clinical trial.

This study enrolls patients that have been diagnosed with osteosarcoma or neuroblastoma that has come back (relapsed) or has not responded to standard treatments (refractory). This study involves an investigational cellular therapy called GD2CART. The study will be testing different doses of the study drug to find the safest dose.

This purpose of this study is to determine the efficacy of humanized CD19 CAR T cells (huCART19) in pediatric and young adult patients with high-risk relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). You may be eligible to participate if you are between the ages of 1-29 years with CD19-expressing B-ALL that is refractory to chemotherapy, has relapsed in the bone marrow <36 months from diagnosis, relapsed more than once, or relapsed after bone marrow transplant or after previous CAR T cell therapy. This study involves the administration of the study drug, blood draws, assessment of leukemia response, chart reviews, and questionnaires. Reimbursement for travel may be provided. If you have questions or would like to learn more about the study, please contact the Cancer Immunotherapy Program at (215) 425-7193. The Principal Investigator is Dr. Shannon Maude and the Immunotherapy Nurse Navigator is Brooke Leibfreid, RN.

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.