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Eneida R. Nemecek, M.D., M.S., M.B.A., Professor of Pediatrics & Medical Oncology
OHSU

Studies

LN-145 Study Cells in Patients With Metastatic Non-Small-Cell Lung Cancer

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The purpose of the study is to learn more about an investigational product called LN-145 (the ‘study cells’) in participants with Non-Small Cell Lung Cancer (NSCLC). The study cells are immune cells that have identified cancer cells as abnormal and have penetrated into the tumor to try to kill cancer cells. These cells are called tumor-infiltrating lymphocytes, or TILs. Participants in this study will have tumor tissue collected during a biopsy or surgery, and the TILs will be isolated and grown in a lab. The TILs will then be given back to the participant. We are hoping to find out if the study cells can be given to participants safely, and if it helps them.

Biological study, Phase 2
All, age 18-70

ABLE 2.0 / PTCTC GVH-1901 Study: Biomarker Verification in Pediatric Chronic Graft-versus-Host Disease

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Graft-versus-host disease (GvHD) is a condition that can occur after a person receives a blood stem cell or bone marrow transplant from a donor. In GvHD, the donor's immune cells (the "graft") could see the recipient's body (the "host") as foreign and attack it. This can cause inflammation and damage to different parts of the body. GvHD can range from mild to severe and is a serious complication of transplant. This study will test a tool designed to predict which children and young adults who receive stem cell transplants might later develop GVHD. The tool classifies patients into low, medium, or high risk of developing GvHD based on certain markers in blood samples before the disease starts. Understanding GVHD better could help doctors improve methods to diagnose, prevent or treat GVHD in the future.

Observational
All, age <25

16-NCTD Study: Multi-Center Phase II Randomized Controlled Trial of Naive T Cell Depletion for Prevention of Chronic Graft Versus Host Disease in Children and Young Adults

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An allogeneic bone marrow transplant is a procedure in which healthy blood stem cells from a donor are given to a patient to replace damaged or diseased bone marrow. It is often used to treat blood cancers such as leukemia or lymphoma. The goal is to restore the body’s ability to produce healthy blood and immune cells from the donor. When a patient receives a stem cell transplant, the donor's immune cells entering the recipient’s body may sometimes perceive the recipient's tissues as foreign and attack them, leading to a condition known as graft-versus-host disease (GVHD). GVHD can be severe and even life-threatening. This clinical trial will test whether a method called naive T-cell depletion can reduce the risk of GVHD. Naive T-cells are a type of immune cell that has not yet encountered any infections or foreign cells. This is a randomized study, which means that participants will be assigned to a treatment arm (transplant with naive T-cell depletion versus traditional transplant without naive T-cell depletion). Randomization means that assignment of the treatment arm will be by chance, similar to flipping a coin. This is done to ensure that each group is similar, which helps compare more fairly how each treatment works.

Interventional therapeutic

Extended vs. Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis (ABA3)

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An allogeneic bone marrow transplant is a procedure in which healthy blood stem cells from a donor are given to a patient to replace damaged or diseased bone marrow. It is often used to treat blood cancers such as leukemia or lymphoma. While the goal is to restore healthy blood and immune cell production, donor immune cells can sometimes attack the recipient's tissues, causing graft-versus-host disease (GVHD), which can be severe or life-threatening. To reduce this risk, closely matched donors are selected, and recipients receive immune-suppressing medications such as cyclosporine or tacrolimus with methotrexate for 5–6 months. Despite these measures, many patients still develop GVHD.This clinical trial will test whether adding a third drug called abatacept in two different dose schedules can reduce the risk of GVHD. Abatacept is a drug approved for GVHD prophylaxis and treatment of rheumatoid arthritis in children and adults. We are hoping to learn whether more doses of abatacept will better prevent severe GVHD than fewer doses.&nbsp;This is a randomized study, which means that participants will be assigned to a treatment arm (short-term versus extended dosing of abatacept). Randomization means that assignment of the study group will be by chance, similar to flipping a coin. The group assignment is blinded which means that neither you nor your investigator doctor will know which group you were assigned to. This is done to ensure that each group is similar and to help compare how the study drug works more fairly and without bias.

Interventional therapeutic

OriCAR-17 in People with Multiple Myeloma that has Come Back after Previous Treatment (Relapsed) or did not Respond to Previous Treatment (Refractory).

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This study is for patients with multiple myeloma. The purpose of the study is to learn more about investigational cells, called OriCAR-017 (the ‘study cells’), which are made from the participant’s own blood cells. This research will find out if the study cells can be given to people safely, identify the most appropriate dose for further research, and see if the study cells may be helpful for people with multiple myeloma that has come back after previous treatment (relapsed) or did not respond to previous treatment (refractory).

Early Phase, Open Label, Interventional

Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects with EBV-PTLD (ALLELE study)

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EBV lymphoproliferative disorder is a condition that can develop after someone is infected with the Epstein-Barr virus (EBV), the same virus that causes infectious mononucleosis(“mono”). In this disorder, the virus causes certain white blood cells, called lymphocytes, to grow and multiply uncontrollably. This can lead to swollen lymph nodes, an enlarged spleen, and sometimes even tumors. EBV lymphoproliferative disorder is more likely to occur in people with weakened immune systems, such as those who have had an organ or bone marrow transplant. The purpose of this study is to test how the study product, Tabelecleucel (tab-cel), works to treat EBV lymphoproliferative disorder (PTLD) following solid organ transplant or hematopoietic cell transplant in participants who have not responded or cannot receive standard treatments for PTLD. Tab-cel is an investgational drug made from special immune cells from healthy donors specifically designed to recognize and kill the EBV virus. These cells may help treat PTLD, but they are still being studied.

drug
All, age 0+

CART-ddBCMA for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

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The purpose of this study is to see if investigational study cells, called CAR T cells, are safe and tolerable for participants with multiple myeloma that has returned after previous treatment (relapsed) or did not respond to previous treatment (refractory). The investigational study cells are made from participant's own immune cells (called T-cells) that are genetically modified by the study funder. The study will also see if the investigational CAR T cells kill tumor cells.

interventional
All, age 18+