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Allogeneic NK cells · 1 trial · 10 indications
Non hematologic AEs will be measured during cycle 1 (first 28 days) and hematologic AEs will be measured during the first 42 days for all dose levels. DLTs are graded for severity by the Common Terminology Criteria for Adverse Events v5.0 (CTCAEv5.0) criteria.
| Arm | Type | Description |
|---|---|---|
| Rtx + Tafasitamab in combination with allogeneic NK Cells | EXPERIMENTAL | This arm includes dose escalation for allogeneic NK cells. All other therapies are given according to standard of care. The length of the treatment period is 28 days per cycle. Participants will be expected to complete one cycle and may have the option to complete a second cycle unless there is evidence of disease progression at the end of the first cycle. |
| Name | Type | Description |
|---|---|---|
| Allogeneic NK cells | DRUG | Allogeneic NK cells are given intravenously (IV) weekly for 3 weeks on Days 0, 7, 14. Dose escalation will be conducted using a Bayesian optimal interval (BOIN) design starting at dose level 1 (500 x 106 cells) and proceeding to dose level 2 (1,000 x 106 cells) if criteria are met. |
| Rituximab | DRUG | Rtx is dosed at 375mg/m2 and give once (on Day -5 for Cycle 1 and Day 0 for Cycle 2, if applicable). |
| Tafasitamab | DRUG | Tafasitamab is dosed at 12 mg/kg and given intravenously (IV) weekly for 3 weeks on Days 0,7,14). |
| Interleukin-2 | DRUG | Interleukin-2 is dosed at 5 million IU and given weekly for 3 weeks on Days 0,7,14. |
| Fludarabine/cyclophosphamide | DRUG | Fludarabine is dosed at 30 mg/m2/d with dose adjustment for renal function, and cyclophosphamide is dosed at 500 mg/m2/d. These are given on 3 days (Days -5 to -3). |
Inclusion Criteria: * Age 18 years or older * Diagnosis of B-cell NHL (indolent and aggressive subtypes) including diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS), high grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), follicular lymphoma (FL), chronic ly...
Allogeneic NK cells are being studied for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and other B-cell malignancies. The investigational therapy is being evaluated in combination with rituximab and tafasitamab in a Phase 1 clinical trial.
Allogeneic NK cells are being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. The company is sponsoring a Phase 1 clinical trial of the therapy in patients with relapsed or refractory B-cell non-Hodgkin lymphoma.
Allogeneic NK cells are in Phase 1 clinical development. The therapy is investigational and has not been approved by regulatory authorities. The ongoing Phase 1 trial is evaluating the safety and tolerability of allogeneic NK cells in combination with rituximab and tafasitamab.
Allogeneic NK cells are being studied in a Phase 1 clinical trial registered as NCT07225439. The trial is not yet recruiting and is planned to enroll 15 participants in the United States. The study combines allogeneic NK cells with rituximab and tafasitamab for patients with relapsed or refractory B-cell non-Hodgkin lymphoma.
No, the Phase 1 clinical trial of Allogeneic NK cells is not randomized and does not use a control group. The trial is an uncontrolled, open-label study designed to evaluate the combination of allogeneic NK cells with rituximab and tafasitamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma.