Table 3.

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%)

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.