General Information |
| Summary |
This is a Phase I study of FT596 in combination with two different schedules (standard or alternate) of R-CHOP in subjects with B-cell lymphoma who are previously untreated or have received no more than one prior line of treatment. The study will consist of a dose-escalation stage followed by a dose-expansion stage. |
| Description |
This is a Phase I study of FT596 in combination with 2 different schedules (standard or alternate) of R-CHOP in subjects with B-cell lymphoma who are previously untreated or have received no more than one prior line of treatment.
The study will evaluate both the clinical benefit of FT596 when combined with R-CHOP given on a standard or alternate schedule.
Subjects will be enrolled in two stages: a dose-escalation stage and a dose-expansion stage. After safety and tolerability have been assessed to define the maximum tolerated dose (MTD) (or the maximum assessed dose [MAD] in the absence of dose limiting toxicities [DLTs] defining the MTD) in the dose-escalation stage, the dose-expansion stage will further evaluate the safety and activity of FT596 in combination. |
| Clinical trials phase |
Phase 1 |
| Start date (estimated) |
2022-12-01 |
| End date (estimated) |
2023-05-01 |
| Clinical feature |
| Label |
diffuse large B-cell lymphoma |
| Link |
http://purl.obolibrary.org/obo/DOID_0050745 |
| Description |
A large B-cell lymphoma that is consisting of medium-sized to large B cells with a diffuse growth pattern. |
|
Administrative Information |
| NCT number |
NCT05934097 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05934097 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/study/NCT05934097 |
| Public contact |
| Email |
clinical@fatetherapeutics.com |
| Public email |
clinical@fatetherapeutics.com |
| First name |
Rebecca |
| Last name |
Reynolds |
| Phone |
+1 (0)858-875-1800 |
| Country |
|
|
| Sponsors |
Fate Therapeutics
|
Cells |
Recruitment |
| Recruitment Status |
Withdrawn |
| Comment recruitment status |
This study was withdrawn (Sponsor decision). |
