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Therapeutic Areas: Oncology | Immunology | Hematology
Disease Category: Non-Hodgkin's Lymphoma
Location: United States, CA
Phase I/II Study of Cellular Immunotherapy Using Central Memory-Enriched CD8+ T Cells Lentivirally Transduced to Express A CD19-Specific Chimeric Immunoreceptor Following Peripheral Blood Stem Cell Transplantation for Patients with High-Risk Intermediate Grade B-Lineage Non-Hodgkin Lymphoma
You have been asked to participate in this research study because you have Non-Hodgkin’s lymphoma (NHL). Your NHL has returned after previous therapy, is no longer responding to therapy or is considered high-risk (such as mantle cell lymphoma, diffuse large cell lymphoma, transformed follicular lymphoma). Your doctor has recommended intensive chemotherapy with Hematopoietic Stem Cell Transplantation (HSCT) to treat your lymphoma.
There are two parts to this research study. The first part is to treat your lymphoma using HSCT. The second part is to give research participants experimental, genetically-modified T-cells after receiving HSCT. This is the Phase I portion of this research study. The purpose of the Phase I portion of the study is to answer the research question “Is the experimental, genetically-modified T cells safe?” This is done by observing any side effects that may be caused by the T cell product. Another aim is to find the highest dose these cells that can be given that is safe.
The experimental, genetically modified product is called TCM-Enriched CD19R-CAR T cells. More information about these cells can be found in Section II (Background). This is the first time that these cells will be used in humans with your disease. Your treatment on this study is expected to last 36 months after you receive your genetically-modified T-cells. After your treatment on this study is over, your medical condition will continue to be followed indefinitely. You are expected to benefit from the HSCT. HSCT is considered standard treatment for your lymphoma (non-experimental portion of the study). Since this is the first time TCM-Enriched CD19R-CAR T cells will be used in humans it is unknown whether you will benefit directly from getting these cells (the experimental portion of this study).
Patient Inclusion/Exclusion Criteria:
- See http://clinicaltrials.coh.org for additional information.
City of Hope
1500 East Duarte Road
Duarte, CA 91010-3000
Phone: 866-896-HOPE (4673)
Research Center Information: City of Hope
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