General Information |
| Summary |
This is a Phase I multi-center study to evaluate the safety of FT596 when given with rituximab as relapse prevention in patients who have undergone an autologous hematopoietic stem cell transplant (auto-HSCT) for diffuse large or high-grade B cell lymphoma. |
| Description |
This study uses a single dose of the investigational product FT596 in the early post-transplant period. Rituximab or an FDA approved by biosimilar including Rituxan®, Truxima®, and Ruxience™ is given 48 to 72 hours prior to FT596. The goal of this study is to 1) establish a maximum tolerated dose (MTD) of FT596 when given 30 days after transplant and 2) to confirm the MTD and safety of giving a single dose of FT596 at Day 7 post-transplant starting at one dose level below the MTD identified at Day 30. |
| Clinical trials phase |
Phase 1 |
| Start date (estimated) |
2020-09-22 |
| End date (estimated) |
2024-02-02 |
| Clinical feature |
| Label |
non-Hodgkin lymphoma |
| Link |
http://purl.obolibrary.org/obo/DOID_0060060 |
| Description |
A lymphoma that is characterized as any kind of lymphoma except Hodgkin's lymphoma.; OMIM mapping confirmed by DO. [LS]. |
|
Administrative Information |
| NCT number |
NCT04555811 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04555811 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/ct2/show/NCT04555811 |
| Sponsors |
Masonic Cancer Center, University of Minnesota
|
Cells |
| Which differentiated cell type is used |
| Label |
natural killer cell |
| Link |
http://purl.obolibrary.org/obo/CL_0000623 |
| Description |
A lymphocyte that can spontaneously kill a variety of target cells without prior antigenic activation via germline encoded activation receptors and also regulate immune responses via cytokine release and direct contact with other cells. |
|
Recruitment |
| Recruitment Status |
Active, not recruiting |
| Estimated number of participants |
3 |
