Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05950334 | FT522 With Rituximab in Relapsed/Refractory B-Cell Lymphoma (FT522-101) | PHASE1 | COMPLETED | 20 | — | — | Nov 16, 2023 | Jun 30, 2025 | Aug 22, 2025 | 7 | United States |
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 |
|---|---|---|---|---|
| Soligenix, Inc. | SNGX | 1 | PHASE3 | Hypericin |
| Incyte Corporation | INCY | 2 | PHASE2 | Ruxolitinib, Pembrolizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | — | Undisclosed |