Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NKR-2 · 1 trial · 2 indications
Dose-limiting toxicity refers to a specific adverse event that is experienced during treatment and until 3 weeks after first NKR-2 dose administration, is new and at least possibly related to NKR-2 study treatment administered following a preconditioning regimen
| Arm | Type | Description |
|---|---|---|
| Phase I Dose Escalation Segment 1 - T7-DL1 | EXPERIMENTAL | Preconditioning (consisting in cyclophosphamide 300 mg/m² and fludarabine 30 mg/m² daily {CYFLU}) at days -9, -8 and -7. Dose 1: 1x108 NKR-2 (adjusted at 1.5x106 NKR-2/kg for patients with body weight ≤ 65 kg) administered at 7 days (T7) after the end of the preconditioning regimen |
| Phase I Dose Escalation Segment 1 - T3-DL1 | EXPERIMENTAL | Preconditioning (consisting in cyclophosphamide 300 mg/m² and fludarabine 30 mg/m² daily {CYFLU}) at days -5, -4 and -3. Dose 1: 1x108 NKR-2 (adjusted at 1.5x106 NKR-2/kg for patients with body weight ≤ 65 kg) administered at 3 days (T3) after the end of the preconditioning regimen |
| Phase I Dose Escalation Segment 1 - T3-DL2 | EXPERIMENTAL | Preconditioning (consisting in cyclophosphamide 300 mg/m² and fludarabine 30 mg/m² daily {CYFLU}) at days -5, -4 and -3. Dose 2: 3x108 NKR-2 (adjusted at 4.6x106 NKR-2/kg for patients with body weight ≤ 65 kg) administered at 3 days (T3) after the end of the preconditioning regimen |
| Phase I Dose Escalation Segment 1 - T3-DL3 | EXPERIMENTAL | Preconditioning (consisting in cyclophosphamide 300 mg/m² and fludarabine 30 mg/m² daily {CYFLU}) at days -5, -4 and -3. Dose 3: 1x109 NKR-2 (adjusted at 1.5x107 NKR-2/kg for patients with body weight ≤ 65 kg) administered at 3 days (T3) after the end of the preconditioning regimen |
| Phase I Dose Escalation - extension | EXPERIMENTAL | This extension segment will enroll more patients (to reach 9 evaluable patients in total) to further evaluate the selected treatment regimen, i.e., the recommended NKR-2 dose (1x108 or 3x108 or 1x109NKR-2/injection) with the CYFLU preconditioning treatment administered at the recommended interval (T3 or T7) prior to NKR-2 administration. |
| Phase II Segment 1 | EXPERIMENTAL | This extension segment will enroll more patients (to reach 13 evaluable patients in total) to further evaluate the selected treatment regimen, i.e., the recommended NKR-2 dose (1x108 or 3x108 or 1x109NKR-2/injection) with the CYFLU preconditioning treatment administered at the recommended interval (T3 or T7) prior to NKR-2 administration. |
| Phase II Segment 2 | EXPERIMENTAL | Enrollment in the Phase II part of the study will be divided in 2 consecutive segments, with 13 patients in total in the segment 1 and 30 new patients in segment 2 (43 patients in total) if the study is not terminated due to futility, according a Simon's two-stage optimal design |
| Name | Type | Description |
|---|---|---|
| NKR-2 | BIOLOGICAL | This Phase I study will explore the hypothesis that the administration of modified T-cells targeting NKG2D-ligands expressed by AML/MDS cells, after a prior nonmyeloablative preconditioning treatment, in patients refractory to and/or relapsing after prior therapies, is safe and, considering the poor outcomes and lack of therapeutic strategies for this patient population, may have a strategic advantage over current approaches and provide potential clinical benefit. |
Inclusion Criteria: 1. The patient must have signed the written ICF and must accept that, beyond the treatment period, and the treatment follow-up period, he/she will have to be monitored for a Long-Term Safety Follow-Up (LTSFU) for up to 15 years after enrollment. 2. Both men and women of all race...
NKR-2 is an investigational monoclonal antibody being studied for the treatment of acute myeloid leukemia (AML). It is being evaluated in patients with AML and myelodysplastic syndromes (MDS). The drug is currently in Phase 1 clinical development and is not yet approved by the FDA.
NKR-2 is being developed by IQVIA Holdings, Inc. (ticker: IQV). The company is conducting clinical research on this investigational therapy for oncology indications, specifically acute myeloid leukemia.
NKR-2 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under evaluation for safety and efficacy.
NKR-2 has been studied in a Phase 1 clinical trial with the identifier NCT03466320, titled "DEPLETHINK - LymphoDEPLEtion and THerapeutic Immunotherapy With NKR-2." The trial enrolled 21 participants with AML and MDS and was conducted in the United States and Belgium.
Yes, NKR-2 is a monoclonal antibody. It is being investigated as a therapeutic option for patients with acute myeloid leukemia and myelodysplastic syndromes. The drug is currently in Phase 1 clinical trials.