Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FT522 · 1 trial · 1 indication
The number of participants experiencing ≥1 DLT will be reported.
The severity of DLTs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, v5.0).
| Arm | Type | Description |
|---|---|---|
| Regimen A | EXPERIMENTAL | Participants receive FT522 in combination with rituximab (or a rituximab biosimilar approved by a local health authority) with chemotherapy. |
| Regimen B | EXPERIMENTAL | Participants receive FT522 in combination with rituximab (or a rituximab biosimilar approved by a local health authority) without chemotherapy. |
| Name | Type | Description |
|---|---|---|
| FT522 | DRUG | FT522 drug product is administered as an intravenous infusion on Days 1, 4 and 8 of a treatment cycle. |
| Rituximab | DRUG | Rituximab will be administered as an IV infusion on Day -4 of the treatment cycle. |
| Cyclophosphamide | DRUG | Cyclophosphamide will be administered as an IV infusion at a dose of 500 mg/m\^2 on Day -5, Day -4, and Day -3 of the treatment cycle. |
| Fludarabine | DRUG | Fludarabine will be administered as an IV infusion at a dose of 30 mg/m\^2 on Day -5, Day -4, and Day -3 of the treatment cycle. |
| Bendamustine | DRUG | Bendamustine will be administered as an IV infusion at a dose of 90 mg/m\^2 on Day -5 and Day -4 of the treatment cycle. Bendamustine may be administered as an alternative to cyclophosphamide/fludarabine. |
Inclusion Criteria: * Diagnosis of B-cell lymphoma (BCL) as: (1) histologically documented lymphomas expected to express CD19 and CD20, including Grades 1 to 3B follicular lymphoma (FL), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM), mantle cell lymphoma (MCL), transformed indole...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Incyte Corporation | INCY | 2 | PHASE2 | Ruxolitinib, Pembrolizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | - | Undisclosed |
FT522 is an investigational small molecule being studied for the treatment of relapsed/refractory B-cell lymphoma. It is currently in Phase 1 clinical development and has not been approved by the FDA.
FT522 is being developed by Fate Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker FATE. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with relapsed/refractory B-cell lymphoma.
FT522 is in Phase 1 clinical development. A Phase 1 clinical trial has been completed, and the drug remains investigational. It has not received FDA approval and is still being evaluated for safety and tolerability.
FT522 has been studied in a Phase 1 clinical trial with the identifier NCT05950334, titled "FT522 With Rituximab in Relapsed/Refractory B-Cell Lymphoma (FT522-101)." This trial enrolled 20 participants in the United States and has been completed.
FT522 is a distinct investigational drug candidate developed by Fate Therapeutics. No alternative names for FT522 have been disclosed in the clinical trial information.