Cancer Immunotherapy Program Clinical Studies

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Phase 1 Study Of Lentivirally Transduced T Cells Engineered To Contain Anti-CD123 In Subjects With Refractory Or Relapsed Acute Myeloid Leukemia

Phase 1 open-label study to estimate the safety, manufacturing feasibility, and efficacy of intravenously administered, lentivirally transduced T cells expressing anti-CD123 in pediatric subjects with relapsed/refractory Acute Myeloid Leukemia (AML). Main study procedures include medical record review, apheresis, CART123 infusion, blood draws, physical exams, imaging, and disease assessments through bone marrows and lumbar punctures. If interested in the study or if you have any questions, please contact 267-426-0762.

Phase 2 trial of CART19 for Orphan Indications Of Pediatric B Cell Acute Lymphoblastic Leukemia (B-ALL)

This is an open-label, four-cohort, phase 2 study to determine the efficacy of CART19 in pediatric and young adult patients with hypodiploid (Cohort A) or t(17;19) B-ALL (Cohort B), infants with very high risk KMT2A B-ALL (Cohort C), and in patients with central nervous system (CNS) relapse who did not receive cranial radiation (XRT) or bone marrow transplantation (BMT) (Cohort D). Possible procedures include medical record review, apheresis, CART19 infusion, blood draws, physical exams, imaging, and disease assessments through bone marrows and lumbar punctures. If interested in the study or if you have any questions, please contact 267-426-0762.

Study of Efficacy and Safety of Tisagenlecleucel in Children and Young Adults with HR B-ALL that is end-consolidation MRD Positive (AALL1721/CASSIOPEIA)

The purpose of this study is to test if the CD19 CAR T cell product tisagenlecleucel (also referred to as CTL019, or Kymriah™) is safe and has beneficial effects in children and young adults who have newly diagnosed high-risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL) that remains MRD-positive after 2 cycles of chemotherapy. The study is enrolling children and young adults between the ages of 1-25 who have received induction and consolidation chemotherapy for HR B-ALL but were still found to have remaining disease (MRD). If you agree to join in this study, you will get one dose of the tisagenlecleucel cells administered by intravenous infusion and be followed for leukemia response. This study also involves blood draws and assessments. 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.

Hodgkin Lymphoma (NHL) (BIANCA)

This purpose of this study is to determine the efficacy and safety of tisagenlecleucel (also referred to as CTL019, or Kymriah™) in children, adolescents and young adults with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL). The study is enrolling children and young adults up to age 25 with CD19-expressing mature B-cell NHL, including Burkitt leukemia/lymphoma, that has relapsed after one or more prior therapies or is primary refractory (not achieved a complete remission (CR) or partial response (PR) after the first line of therapy). This study involves the administration of the study drug, blood draws, assessment of lymphoma response, and chart reviews. After a process called leukapheresis, in which T cells (a type of white blood cell) are removed from the subject's blood and modified in order to target the lymphoma, they are returned back to the subject as the study drug. 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.

KTE-X19

Patients with no available curative treatment options with leukemia are eligible to participate in this study to test an experimental approach called gene transfer that involves B cells. This study will take the patients white blood cells - T cells - and change them to turn against the cancer.

CD33 CART AML

This phase 1/2 study will determine the safety, feasibility, and efficacy of CD33 CART cells following lymphodepleting chemotherapy in patients with acute myeloid leukemia (AML). Patients who are between ages 1 to 30 years with relapsed or refractory AML will be eligible for this study.

Humanized CART19 Phase 2 Trial

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.

Allo CD7 CAR WU-CART-007

The purpose of this study is to determine the safety and tolerability of an experimental form of therapy, known as WU-CART-007 (“study drug”).  WU-CART-007 uses immune cells, called T cells, that are genetically changed to identify cancer cells. In this study, T cells are collected from a healthy human donor and have been modified in a laboratory. If the genetically changed T cells recognize and attach to cancer cells, they may have the ability to kill those cancer cells.

Patients with T-cell Acute Lymphoblatic Leukemia (T-ALL) or Lymphoblastic Lymphoma (LBL), where the disease has come back (relapsed) or has not responded to treatment (refractory) may be eligible for the study.
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