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...
Top 1 of 2 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Incyte Corporation | INCY | 2 | PHASE2 | Ruxolitinib |
FT522 is an investigational small molecule developed by Fate Therapeutics, Inc. for relapsed or refractory B-cell lymphoma. It is designed to target CD19 and is being studied in combination with rituximab. FT522 has completed a Phase 1 clinical trial and is not approved for any indication.
FT522 is being evaluated for the treatment of relapsed or refractory B-cell lymphoma, a cancer of the lymphatic system that has returned or not responded to prior therapy. It is administered in combination with rituximab in a Phase 1 study. FT522 remains investigational and is not approved for commercial use.
FT522 targets CD19, a protein expressed on the surface of B cells. By binding CD19, FT522 is designed to act against malignant B cells in relapsed or refractory B-cell lymphoma. CD19 is a well-characterized target in B-cell malignancies and is the molecular target of FT522.
FT522 is being developed by Fate Therapeutics, Inc., a clinical-stage biopharmaceutical company. Fate Therapeutics trades on the Nasdaq under the ticker symbol FATE. The company is the sponsor of the Phase 1 trial evaluating FT522 in relapsed or refractory B-cell lymphoma.
FT522 is in Phase 1 clinical development. A single Phase 1 trial, NCT05950334, has been completed. The study enrolled 20 participants and evaluated FT522 in combination with rituximab in relapsed or refractory B-cell lymphoma. FT522 is investigational and has not received FDA approval.
FT522 has been studied in one clinical trial, NCT05950334, titled FT522 With Rituximab in Relapsed/Refractory B-Cell Lymphoma (FT522-101). This Phase 1 trial was conducted in the United States, enrolled 20 participants aged 18 years and older, and has been completed. No active trials are currently listed.