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A Phase 1 Basket Study Evaluating the Safety and Feasibility of T Plex, Autologous Customized T Cell Receptor Engineered T Cells Targeting Multiple Peptide/HLA Antigens in Pa rticipants with Antigen positive Locally Advanced (Unresectable) or Metastatic

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT05973487

Population:

Adult

Phase:

I

The purpose of the study is to learn if the study treatments TSC-204-A0201, TSC 200- A020, and TSC-204-C0702 alone or in combination, referred to as T-Plex, are safe and effective in treating your type of cancer. T-Plex has not yet been approved by the Food and Drug Administration (FDA). This is a first-in-human study, which means that these products have never been administered to humans before. You are unlikely to benefit from taking part in this study. Are you Eligible? (Inclusion Criteria) Must be 18 years or older - Diagnosed with a locally advanced (unresectable) or metastatic solid...
LCH-IV International Collaborative Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis

Principal Investigator:

Justine Kahn, MD

Contact Number:

212-342-5162

NCT Number:

NCT02205762

Population:

Pediatrics

Phase:

II/III

The LCH-IV is an international, multicenter, prospective clinical study for pediatric Langerhans Cell Histiocytosis LCH (age < 18 years). LCH is a rare disease of the immune system that may affect any age group. It can affect many different organs, including the skeleton, skin, lymph nodes, liver, lungs, spleen, hematopoiesis, or central nervous system (CNS). There are two widely recognized disease extent categories: single-system LCH (involvement of a single organ or system) and multisystem LCH (involvement of 2 or more organ systems). Patients with SS-LCH of the skeleton, skin, or the...
A Phase 1/2, Open-Label Study of the Pressure-Enabled Hepatic Artery Infusion of SD-101, a TLR9 Agonist, Alone or in Combination with Intravenous Checkpoint Blockade in Adults with Metastatic Uveal Melanoma

Principal Investigator:

Alexander Z. Wei, MD

Contact Number:

212-342-5162

NCT Number:

NCT04935229

Population:

Adult

Phase:

I

The purpose of this study is to determine the best level of dose of SD-101 given by hepatic artery infusion (HAI, a method of putting medication directly into your liver) with using Pressure-Enabled Drug Delivery™ (PEDD™) alone or in combination with nivolumab and/or ipilimumab. Also to find out what effects (both good and bad) SD-101 given by HAI with PEDD has on you and your cancer when given alone or with nivolumab and/or ipilimumab. Are you Eligible? (Inclusion Criteria) Must be 18 years or older at time of consent Confirmed diagnosis of metastatic uveal melanoma with liver...
A PHASE 1/2 MULTI-CENTER STUDY EVALUATING THE SAFETY AND EFFICACY OF KTE-X19 IN PEDIATRIC AND ADOLESCENT SUBJECTS WITH RELAPSED/REFRACTORY B-PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA OR RELAPSED/REFRACTORY B-CELL NON-HODGKIN LYMPHOMA (ZUMA 4)

Principal Investigator:

Prakash Satwani, MD

Contact Number:

212-342-5162

NCT Number:

NCT02625480

Population:

Pediatrics/Adult

Phase:

I/II

Kite Pharma, Inc., a for-profit biotechnology company, is funding this research study and has designed the trial. The sponsor is testing an experimental treatment named KTE-C19, which uses the patient’s own genetically altered blood cells to treat cancer. KTE-C19 is made from blood cells that are removed from the patient. A virus (retrovirus) is used to introduce a gene that creates a protein (called a chimeric antigen receptor or CAR) on the surface of T cells, a type of blood cell that fights infection and eliminates cancer cells. The main purpose of this research study is to...
ACCESS: A Multi-Center, Phase II Trial of HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation with Post-Transplantation Cyclophosphamide for Patients with Hematologic Malignancies

Principal Investigator:

Ran Reshef, MD, MSc

Contact Number:

212-342-5162

NCT Number:

NCT04904588

Population:

Adult

Phase:

II

with a MMUD using stem cells from a donor’s blood [instead of using the donor’s bone marrow]. An allogeneic stem cell transplant is a standard treatment for blood cancers. An allogeneic transplant replaces your abnormal (or diseased) blood cells with healthy blood-making cells from a donor. We’re doing this study to see how well transplant works in adults with a MMUD using stem cells from a donor’s blood. This study treatment does not include any investigational drugs. Are you Eligible? (Inclusion Criteria) Donor: 1. Are you 18 year of age or older and younger then 36...
Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and

Principal Investigator:

Ran Reshef, MD, MSc

Contact Number:

212-342-5162

NCT Number:

NCT03394365

Population:

Pediatrics/Adult

Phase:

III

Epstein-Barr Virus (EBV) is the virus that causes mononucleosis, also known as “mono”. Almost all adults have had EBV. For most people, EBV never causes a health problem. However, when their immune system is not working properly (like people who have had a transplant and must be on medications that suppress their immune system), EBV can cause certain diseases where cells grow abnormally. EBV-associated Post-Transplant Lymphoproliferative Disease (EBV-PTLD) is a condition that can occur after a solid organ transplant (SOT) where EBV infects immune cells in your blood, called B...

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