Treatment outcomes
| P-ML ID . | NK cell dose* (total cells) . | Time from FLAG to NK cell infusion . | Day 28 disease assessment (% BM blasts) . | Day 28 disease response . | Day 100 disease assessment (% BM blasts) . | Day 100 disease response . | Current status . |
|---|---|---|---|---|---|---|---|
| 2 | 1.86 × 108 | 26 d | MRD negative | CR | MRD negative | CRi | CD34 boost given, remained in remission >2 y after therapy |
| 4 | 2.19 × 108 | 29 d | Peripheral blasts, BM not assessed* | PD† | NA | NA | Disease progression before day 7 and expired before day 28 |
| 5 | 8.69 × 108 | 25 d | MRD negative | CR | NA | NA | Extramedullary disease progression, off study after day 60, expired |
| 7 | 1.38 × 108 | 18 d | MRD negative | CR | 3 | PR | Proceeded to second transplant, remained alive and disease free |
| 8 | 1.53 × 108 | 16 d | MRD negative | CR | MRD negative | CR | Disease progression at day 180, proceeded to second transplant, remained alive and disease free |
| 9 | 4.26 × 108 | 16 d | 56% | PD | NA | NA | Off study after day 70, expired due to disease progression |
| 10 | 1.17 × 108 | 16 d | 16% | PR | 30 | PD | Expired due to disease progression |
| 11 | 1.4 × 108 | 17 d | 10% | PR | 60 | PD | Expired due to disease progression |
| Summary | 2.81 × 108 (average) | 22 d (average) | 4 MRD negative | 4 CR, 2 PR (75% patients with response) | 2 MRD negative | 2 CR/CRi (25% patients remained in CR) | One patient remained in remission >2 y; 3 alive at 2 y (27.5%) |
| P-ML ID . | NK cell dose* (total cells) . | Time from FLAG to NK cell infusion . | Day 28 disease assessment (% BM blasts) . | Day 28 disease response . | Day 100 disease assessment (% BM blasts) . | Day 100 disease response . | Current status . |
|---|---|---|---|---|---|---|---|
| 2 | 1.86 × 108 | 26 d | MRD negative | CR | MRD negative | CRi | CD34 boost given, remained in remission >2 y after therapy |
| 4 | 2.19 × 108 | 29 d | Peripheral blasts, BM not assessed* | PD† | NA | NA | Disease progression before day 7 and expired before day 28 |
| 5 | 8.69 × 108 | 25 d | MRD negative | CR | NA | NA | Extramedullary disease progression, off study after day 60, expired |
| 7 | 1.38 × 108 | 18 d | MRD negative | CR | 3 | PR | Proceeded to second transplant, remained alive and disease free |
| 8 | 1.53 × 108 | 16 d | MRD negative | CR | MRD negative | CR | Disease progression at day 180, proceeded to second transplant, remained alive and disease free |
| 9 | 4.26 × 108 | 16 d | 56% | PD | NA | NA | Off study after day 70, expired due to disease progression |
| 10 | 1.17 × 108 | 16 d | 16% | PR | 30 | PD | Expired due to disease progression |
| 11 | 1.4 × 108 | 17 d | 10% | PR | 60 | PD | Expired due to disease progression |
| Summary | 2.81 × 108 (average) | 22 d (average) | 4 MRD negative | 4 CR, 2 PR (75% patients with response) | 2 MRD negative | 2 CR/CRi (25% patients remained in CR) | One patient remained in remission >2 y; 3 alive at 2 y (27.5%) |
Treatment outcomes based on IWG criteria for evaluable patients enrolled in the trial who received immunotherapy. Patient P-ML003 had a phenotypic change from AML to T-cell lymphoblastic leukemia at the start of study therapy and was not included in the efficacy assessment.
MRD, minimal residual disease; NA, not available; PD, progressive disease; PR, partial response.
Patients received between 4 × 106 and 10 × 106 NK cells per kilogram (average, 11 × 106 NK cells per kg). Total dose was calculated as (10 × 106 NK cells per kg) × (weight in kg).
Day 28 PD assigned based on patient’s early disease progression. CRi, complete remission with incomplete count recovery.