Trial Outcomes & Findings for A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS) (NCT NCT04079296)

NCT ID: NCT04079296

Last Updated: 2024-11-26

Results Overview

DLT was defined as any of the following events that occurred within 28 days starting with the first dose on cycle 1 day 1 (C1D1) and that was considered to be related to study drug. DLT was defined as follows: * Grade 3 of more : non-hematologic AEs that are ≥ grade 3 * Confirmed Hy's law case * New onset of grade 4 thrombocytopenia (with minimum of 2 grade worsening from baseline) within 24 hours of dosing * Prolonged myelosuppression, defined as absolute neutrophil count (ANC) \< 500/microliter (μL) for more than 28 days off therapy and in the absence of evidence of active leukemia or MDS in the marrow or blood.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 43 participants
• Primary outcome timeframe: Day 1 up to 28 days
• Results posted on: 2024-11-26

Participant Flow

Participants with relapsed/refractory acute myeloid leukemia and relapsed/refractory higher risk myelodysplastic syndrome were enrolled in the study.

Participants who met all inclusion criteria and none of the exclusion criteria were enrolled in the study.

Participant milestones

Measure	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL Participants with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) and R/R higher risk Myelodysplastic Syndrome (MDS) received intravenous (IV) infusion of ASP7517 (human embryonic kidney cell \[HEK293\] transfected with encoding target WT-1) at a dose of 1x10\^6 cells/milliliters (mL) at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).
Dose Escalation Phase (56 Days) STARTED	6	5	8	0	0
Dose Escalation Phase (56 Days) COMPLETED	2	1	4	0	0
Dose Escalation Phase (56 Days) NOT COMPLETED	4	4	4	0	0
Dose Expansion Phase (168 Days) STARTED	0	0	0	12	12
Dose Expansion Phase (168 Days) COMPLETED	0	0	0	1	3
Dose Expansion Phase (168 Days) NOT COMPLETED	0	0	0	11	9

Reasons for withdrawal

Measure	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL Participants with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) and R/R higher risk Myelodysplastic Syndrome (MDS) received intravenous (IV) infusion of ASP7517 (human embryonic kidney cell \[HEK293\] transfected with encoding target WT-1) at a dose of 1x10\^6 cells/milliliters (mL) at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).
Dose Escalation Phase (56 Days) Progressive disease	1	1	1	0	0
Dose Escalation Phase (56 Days) Lack of Efficacy	3	3	3	0	0
Dose Expansion Phase (168 Days) Miscellaneous	0	0	0	0	1
Dose Expansion Phase (168 Days) Withdrawal by Subject	0	0	0	0	1
Dose Expansion Phase (168 Days) Physician Decision	0	0	0	1	0
Dose Expansion Phase (168 Days) Progressive Disease	0	0	0	6	5
Dose Expansion Phase (168 Days) Lack of Efficacy	0	0	0	3	2
Dose Expansion Phase (168 Days) Death	0	0	0	1	0

Baseline Characteristics

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)

Baseline characteristics by cohort

Measure	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=6 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=5 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=8 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=12 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=12 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Total n=43 Participants Total of all reporting groups
Age, Continuous	70.7 Years STANDARD_DEVIATION 3.8 • n=5 Participants	76.2 Years STANDARD_DEVIATION 4.3 • n=7 Participants	76.1 Years STANDARD_DEVIATION 2.5 • n=5 Participants	72.8 Years STANDARD_DEVIATION 4.5 • n=4 Participants	70.8 Years STANDARD_DEVIATION 7.7 • n=21 Participants	73.0 Years STANDARD_DEVIATION 5.5 • n=8 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	15 Participants n=8 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants	8 Participants n=21 Participants	28 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants	11 Participants n=4 Participants	11 Participants n=21 Participants	38 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants	10 Participants n=4 Participants	9 Participants n=21 Participants	38 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
ECOG Perfomance Status (PS) Grade 0	1 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants	5 Participants n=21 Participants	20 Participants n=8 Participants
ECOG Perfomance Status (PS) Grade 1	5 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants	19 Participants n=8 Participants
ECOG Perfomance Status (PS) Grade 2	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants
ECOG Perfomance Status (PS) Grade 3	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
ECOG Perfomance Status (PS) Grade 4	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
ECOG Perfomance Status (PS) Grade 5	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants

PRIMARY outcome

Timeframe: Day 1 up to 28 days

Population: The safety analysis set (SAF) consisted of all participants who were enrolled and received at least 1 dose of study drug. SAF with available data was analyzed

DLT was defined as any of the following events that occurred within 28 days starting with the first dose on cycle 1 day 1 (C1D1) and that was considered to be related to study drug. DLT was defined as follows:

• Grade 3 of more : non-hematologic AEs that are ≥ grade 3
• Confirmed Hy's law case
• New onset of grade 4 thrombocytopenia (with minimum of 2 grade worsening from baseline) within 24 hours of dosing
• Prolonged myelosuppression, defined as absolute neutrophil count (ANC) < 500/microliter (μL) for more than 28 days off therapy and in the absence of evidence of active leukemia or MDS in the marrow or blood.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=4 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=6 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=9 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=4 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=11 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With Dose Limiting Toxicities (DLTs)	0 participants	0 participants	0 participants	0 participants	1 participants	—

PRIMARY outcome

Timeframe: From first dose up to 43 months

Population: SAF

An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An AE was considered "serious" if, it resulted in any of the following outcomes: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly, or birth defect; requires inpatient hospitalization; or leads to prolongation of hospitalization; other medically important events. TEAE was defined as an AE observed after starting administration of the study drug. TEAEs included both Serious and non-serious AEs.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=5 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=8 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=12 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=6 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=12 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With Treatment Emergent Adverse Events (TEAE) & Serious TEAE TEAE	5 participants	6 participants	12 participants	5 participants	10 participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) & Serious TEAE Serious TEAE	4 participants	2 participants	8 participants	1 participants	5 participants	—

PRIMARY outcome

Timeframe: From first dose up to 43 months

Population: FAS with available data was analyzed

Percentage of participants with CRc was reported. CRc:defined as rate of all complete & incomplete remissions (CR + CR with incomplete platelet recovery [CRp] + CR with incomplete hematological recover [Cri]). CR: achieved morphologic leukemia-free state & their bone marrow was regenerating normal hematopoietic cells. If absolute neutrophil count (ANC) ≥ 1×10^9/L, platelet count (PC) ≥ 100×10^9/L, normal marrow differential < 5% blasts, & were red blood cell (RBC) and platelet transfusion independent (defined as 1 week without RBC transfusion & platelet transfusion prior to disease assessment). There was no evidence of extramedullary leukemia or Auer rods & blast counts in peripheral blood must be ≤ 2%. CRp: must achieve CR except for incomplete platelet recovery (< 100×10^9/L). CRi: must fulfil CR except for incomplete hematological recovery with residual neutropenia (ANC < 1×10^9/L), with or without complete platelet recovery. RBC and platelet transfusion independence not required.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=3 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=7 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=12 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=5 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Phase 2: Composite Complete Remission (CRc) Rate for Participants With R/R AML	0.0 percentage of participants Interval 0.0 to 63.2	14.3 percentage of participants Interval 0.7 to 52.1	8.3 percentage of participants Interval 0.4 to 33.9	0.0 percentage of participants Interval 0.0 to 45.1	—	—

PRIMARY outcome

Timeframe: From first dose up to 43 months

Population: FAS with available data was analyzed

Percentage of participants with CR+BM CR+ PR was reported. CR, BM CR and PR achieved for minimum of 4 weeks; CR: bone marrow: ≤ 5% myeloblasts with normal maturation of all cell Lines, peripheral blood evaluation (hemoglobin (Hb) ≥ 11 g/dL, platelets ≥ 100 × 10^9/L, neutrophils ≥ 1.0 × 10^9/L, 0% blasts in blood)

BM CR: bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment

PR: achieved all CR criteria except bone marrow blasts decreased by ≥ 50% over pretreatment but still > 5%, cellularity and morphology not relevant.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=2 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=1 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=12 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=1 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Phase 2: Complete Remission + Bone Marrow Complete Remission + Partial Remission (CR + BM CR + PR) Rate for Participants With R/R Higher Risk MDS	0.0 percentage of participants Interval 0.0 to 77.6	0.0 percentage of participants Interval 0.0 to 95.0	0.0 percentage of participants Interval 0.0 to 22.1	100.0 percentage of participants Interval 5.0 to 100.0	—	—

PRIMARY outcome

Timeframe: C1D2

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=5 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=8 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=12 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=6 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=11 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at Cycle 1(C1) Day2(D2) Grade 0	3 participants	3 participants	8 participants	1 participants	6 participants	—
Number of Participants With ECOG Performance Status at Cycle 1(C1) Day2(D2) Grade 1	2 participants	4 participants	2 participants	5 participants	4 participants	—
Number of Participants With ECOG Performance Status at Cycle 1(C1) Day2(D2) Grade 2	0 participants	1 participants	2 participants	0 participants	1 participants	—
Number of Participants With ECOG Performance Status at Cycle 1(C1) Day2(D2) Grade 3	0 participants	0 participants	0 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at Cycle 1(C1) Day2(D2) Grade 4	0 participants	0 participants	0 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at Cycle 1(C1) Day2(D2) Grade 5	0 participants	0 participants	0 participants	0 participants	0 participants	—

PRIMARY outcome

Timeframe: C1D4

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=5 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=8 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=6 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C1D4 Grade 0	3 participants	2 participants	—	1 participants	—	—
Number of Participants With ECOG Performance Status at C1D4 Grade 1	2 participants	5 participants	—	5 participants	—	—
Number of Participants With ECOG Performance Status at C1D4 Grade 2	0 participants	1 participants	—	0 participants	—	—
Number of Participants With ECOG Performance Status at C1D4 Grade 3	0 participants	0 participants	—	0 participants	—	—
Number of Participants With ECOG Performance Status at C1D4 Grade 4	0 participants	0 participants	—	0 participants	—	—
Number of Participants With ECOG Performance Status at C1D4 Grade 5	0 participants	0 participants	—	0 participants	—	—

PRIMARY outcome

Timeframe: C1D8

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=5 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=8 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=12 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=6 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=12 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C1D8 Grade 5	0 participants	0 participants	0 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at C1D8 Grade 0	3 participants	2 participants	8 participants	1 participants	4 participants	—
Number of Participants With ECOG Performance Status at C1D8 Grade 2	0 participants	1 participants	2 participants	0 participants	1 participants	—
Number of Participants With ECOG Performance Status at C1D8 Grade 3	0 participants	0 participants	0 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at C1D8 Grade 4	0 participants	0 participants	0 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at C1D8 Grade 1	2 participants	5 participants	2 participants	5 participants	7 participants	—

PRIMARY outcome

Timeframe: C1D11

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=5 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=8 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C1D11 Grade 0	3 participants	2 participants	—	—	—	—
Number of Participants With ECOG Performance Status at C1D11 Grade 1	2 participants	5 participants	—	—	—	—
Number of Participants With ECOG Performance Status at C1D11 Grade 3	0 participants	0 participants	—	—	—	—
Number of Participants With ECOG Performance Status at C1D11 Grade 4	0 participants	0 participants	—	—	—	—
Number of Participants With ECOG Performance Status at C1D11 Grade 5	0 participants	0 participants	—	—	—	—
Number of Participants With ECOG Performance Status at C1D11 Grade 2	0 participants	1 participants	—	—	—	—

PRIMARY outcome

Timeframe: C1D15

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=5 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=8 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=12 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=5 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=12 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C1D15 Grade 0	3 participants	3 participants	5 participants	2 participants	5 participants	—
Number of Participants With ECOG Performance Status at C1D15 Grade 1	2 participants	4 participants	4 participants	3 participants	5 participants	—
Number of Participants With ECOG Performance Status at C1D15 Grade 2	0 participants	1 participants	2 participants	0 participants	2 participants	—
Number of Participants With ECOG Performance Status at C1D15 Grade 3	0 participants	0 participants	1 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at C1D15 Grade 4	0 participants	0 participants	0 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at C1D15 Grade 5	0 participants	0 participants	0 participants	0 participants	0 participants	—

PRIMARY outcome

Timeframe: C1D18

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=5 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=7 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C1D18 Grade 0	3 participants	3 participants	—	—	—	—
Number of Participants With ECOG Performance Status at C1D18 Grade 1	2 participants	3 participants	—	—	—	—
Number of Participants With ECOG Performance Status at C1D18 Grade 2	0 participants	1 participants	—	—	—	—
Number of Participants With ECOG Performance Status at C1D18 Grade 3	0 participants	0 participants	—	—	—	—
Number of Participants With ECOG Performance Status at C1D18 Grade 4	0 participants	0 participants	—	—	—	—
Number of Participants With ECOG Performance Status at C1D18 Grade 5	0 participants	0 participants	—	—	—	—

PRIMARY outcome

Timeframe: C1D22

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=5 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=7 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=9 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=4 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=8 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C1D22 Grade 0	3 participants	3 participants	6 participants	2 participants	3 participants	—
Number of Participants With ECOG Performance Status at C1D22 Grade 1	2 participants	3 participants	1 participants	2 participants	4 participants	—
Number of Participants With ECOG Performance Status at C1D22 Grade 2	0 participants	1 participants	1 participants	0 participants	1 participants	—
Number of Participants With ECOG Performance Status at C1D22 Grade 3	0 participants	0 participants	1 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at C1D22 Grade 4	0 participants	0 participants	0 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at C1D22 Grade 5	0 participants	0 participants	0 participants	0 participants	0 participants	—

PRIMARY outcome

Timeframe: C1D25

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=4 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=7 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C1D25 Grade 0	2 participants	3 participants	—	—	—	—
Number of Participants With ECOG Performance Status at C1D25 Grade 1	2 participants	3 participants	—	—	—	—
Number of Participants With ECOG Performance Status at C1D25 Grade 2	0 participants	1 participants	—	—	—	—
Number of Participants With ECOG Performance Status at C1D25 Grade 3	0 participants	0 participants	—	—	—	—
Number of Participants With ECOG Performance Status at C1D25 Grade 4	0 participants	0 participants	—	—	—	—
Number of Participants With ECOG Performance Status at C1D25 Grade 5	0 participants	0 participants	—	—	—	—

PRIMARY outcome

Timeframe: C2D1

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=4 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=6 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=8 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=4 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=9 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C2D1 Grade 0	1 participants	2 participants	6 participants	1 participants	4 participants	—
Number of Participants With ECOG Performance Status at C2D1 Grade 1	3 participants	3 participants	0 participants	3 participants	5 participants	—
Number of Participants With ECOG Performance Status at C2D1 Grade 2	0 participants	0 participants	2 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at C2D1 Grade 3	0 participants	1 participants	0 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at C2D1 Grade 4	0 participants	0 participants	0 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at C2D1 Grade 5	0 participants	0 participants	0 participants	0 participants	0 participants	—

PRIMARY outcome

Timeframe: C2D2

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=3 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=6 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=8 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=4 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=8 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C2D2 Grade 0	1 participants	3 participants	5 participants	1 participants	4 participants	—
Number of Participants With ECOG Performance Status at C2D2 Grade 1	2 participants	2 participants	0 participants	3 participants	4 participants	—
Number of Participants With ECOG Performance Status at C2D2 Grade 2	0 participants	0 participants	3 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at C2D2 Grade 3	0 participants	1 participants	0 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at C2D2 Grade 4	0 participants	0 participants	0 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at C2D2 Grade 5	0 participants	0 participants	0 participants	0 participants	0 participants	—

PRIMARY outcome

Timeframe: C2D4

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=2 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=6 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=4 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C2D4 Grade 4	0 participants	0 participants	—	0 participants	—	—
Number of Participants With ECOG Performance Status at C2D4 Grade 0	0 participants	3 participants	—	1 participants	—	—
Number of Participants With ECOG Performance Status at C2D4 Grade 1	2 participants	2 participants	—	3 participants	—	—
Number of Participants With ECOG Performance Status at C2D4 Grade 2	0 participants	0 participants	—	0 participants	—	—
Number of Participants With ECOG Performance Status at C2D4 Grade 3	0 participants	1 participants	—	0 participants	—	—
Number of Participants With ECOG Performance Status at C2D4 Grade 5	0 participants	0 participants	—	0 participants	—	—

PRIMARY outcome

Timeframe: C2D8

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=2 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=6 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=8 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=4 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=6 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C2D8 Grade 0	0 participants	2 participants	6 participants	2 participants	3 participants	—
Number of Participants With ECOG Performance Status at C2D8 Grade 1	2 participants	3 participants	1 participants	2 participants	3 participants	—
Number of Participants With ECOG Performance Status at C2D8 Grade 2	0 participants	1 participants	1 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at C2D8 Grade 3	0 participants	0 participants	0 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at C2D8 Grade 4	0 participants	0 participants	0 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at C2D8 Grade 5	0 participants	0 participants	0 participants	0 participants	0 participants	—

PRIMARY outcome

Timeframe: C2D15

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=1 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=5 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=6 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=3 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=7 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C2D15 Grade 0	0 participants	2 participants	5 participants	2 participants	3 participants	—
Number of Participants With ECOG Performance Status at C2D15 Grade 1	1 participants	2 participants	1 participants	1 participants	4 participants	—
Number of Participants With ECOG Performance Status at C2D15 Grade 2	0 participants	1 participants	0 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at C2D15 Grade 3	0 participants	0 participants	0 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at C2D15 Grade 4	0 participants	0 participants	0 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at C2D15 Grade 5	0 participants	0 participants	0 participants	0 participants	0 participants	—

PRIMARY outcome

Timeframe: C2D22

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=1 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=5 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=5 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=3 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=7 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C2D22 Grade 1	1 participants	1 participants	1 participants	1 participants	4 participants	—
Number of Participants With ECOG Performance Status at C2D22 Grade 2	0 participants	1 participants	1 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at C2D22 Grade 0	0 participants	3 participants	3 participants	2 participants	3 participants	—
Number of Participants With ECOG Performance Status at C2D22 Grade 3	0 participants	0 participants	0 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at C2D22 Grade 4	0 participants	0 participants	0 participants	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at C2D22 Grade 5	0 participants	0 participants	0 participants	0 participants	0 participants	—

PRIMARY outcome

Timeframe: C3D1

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=3 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=7 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C3D1 Grade 3	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C3D1 Grade 0	—	—	2 participants	—	3 participants	—
Number of Participants With ECOG Performance Status at C3D1 Grade 1	—	—	0 participants	—	4 participants	—
Number of Participants With ECOG Performance Status at C3D1 Grade 2	—	—	1 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C3D1 Grade 4	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C3D1 Grade 5	—	—	0 participants	—	0 participants	—

PRIMARY outcome

Timeframe: C3D15

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=3 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=6 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C3D15 Grade 0	—	—	1 participants	—	3 participants	—
Number of Participants With ECOG Performance Status at C3D15 Grade 1	—	—	2 participants	—	3 participants	—
Number of Participants With ECOG Performance Status at C3D15 Grade 2	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C3D15 Grade 3	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C3D15 Grade 4	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C3D15 Grade 5	—	—	0 participants	—	0 participants	—

PRIMARY outcome

Timeframe: C4D1

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=3 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=5 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C4D1 Grade 0	—	—	1 participants	—	2 participants	—
Number of Participants With ECOG Performance Status at C4D1 Grade 1	—	—	2 participants	—	3 participants	—
Number of Participants With ECOG Performance Status at C4D1 Grade 2	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C4D1 Grade 3	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C4D1 Grade 4	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C4D1 Grade 5	—	—	0 participants	—	0 participants	—

PRIMARY outcome

Timeframe: C4D15

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=2 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=4 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C4D15 Grade 3	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C4D15 Grade 0	—	—	1 participants	—	2 participants	—
Number of Participants With ECOG Performance Status at C4D15 Grade 1	—	—	1 participants	—	2 participants	—
Number of Participants With ECOG Performance Status at C4D15 Grade 2	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C4D15 Grade 4	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C4D15 Grade 5	—	—	0 participants	—	0 participants	—

PRIMARY outcome

Timeframe: C5D1

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=2 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=5 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C5D1 Grade 0	—	—	1 participants	—	2 participants	—
Number of Participants With ECOG Performance Status at C5D1 Grade 1	—	—	1 participants	—	3 participants	—
Number of Participants With ECOG Performance Status at C5D1 Grade 4	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C5D1 Grade 5	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C5D1 Grade 2	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C5D1 Grade 3	—	—	0 participants	—	0 participants	—

PRIMARY outcome

Timeframe: C5D15

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=1 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=5 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C5D15 Grade 1	—	—	0 participants	—	3 participants	—
Number of Participants With ECOG Performance Status at C5D15 Grade 2	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C5D15 Grade 3	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C5D15 Grade 4	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C5D15 Grade 5	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C5D15 Gade 0	—	—	1 participants	—	2 participants	—

PRIMARY outcome

Timeframe: C6D1

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=1 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=3 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C6D1 Grade 0	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C6D1 Grade 1	—	—	1 participants	—	3 participants	—
Number of Participants With ECOG Performance Status at C6D1 Grade 2	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C6D1 Grade 3	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C6D1 Grade 4	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C6D1 Grade 5	—	—	0 participants	—	0 participants	—

PRIMARY outcome

Timeframe: C6D15

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=1 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=2 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C6D15 Grade 0	—	—	0 participants	—	1 participants	—
Number of Participants With ECOG Performance Status at C6D15 Grade 3	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C6D15 Grade 4	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C6D15 Grade 5	—	—	0 participants	—	0 participants	—
Number of Participants With ECOG Performance Status at C6D15 Grade 1	—	—	1 participants	—	1 participants	—
Number of Participants With ECOG Performance Status at C6D15 Grade 2	—	—	0 participants	—	0 participants	—

PRIMARY outcome

Timeframe: EOT (up to 63 Days)

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

EOT was calculated as last dose plus 7 days.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=3 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=8 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=5 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at End of Treatment (EOT) (Dose Escalation Phase) Grade 1	2 participants	3 participants	—	2 participants	—	—
Number of Participants With ECOG Performance Status at End of Treatment (EOT) (Dose Escalation Phase) Grade 2	0 participants	1 participants	—	0 participants	—	—
Number of Participants With ECOG Performance Status at End of Treatment (EOT) (Dose Escalation Phase) Grade 3	0 participants	1 participants	—	0 participants	—	—
Number of Participants With ECOG Performance Status at End of Treatment (EOT) (Dose Escalation Phase) Grade 4	0 participants	0 participants	—	0 participants	—	—
Number of Participants With ECOG Performance Status at End of Treatment (EOT) (Dose Escalation Phase) Grade 0	1 participants	3 participants	—	3 participants	—	—
Number of Participants With ECOG Performance Status at End of Treatment (EOT) (Dose Escalation Phase) Grade 5	0 participants	0 participants	—	0 participants	—	—

PRIMARY outcome

Timeframe: EOT (up to 175 days)

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

EOT was calculated as last dose plus 7 days.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=10 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=11 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at EOT (Dose Expansion Phase) Grade 0	2 participants	—	—	5 participants	—	—
Number of Participants With ECOG Performance Status at EOT (Dose Expansion Phase) Grade 3	1 participants	—	—	1 participants	—	—
Number of Participants With ECOG Performance Status at EOT (Dose Expansion Phase) Grade 5	0 participants	—	—	0 participants	—	—
Number of Participants With ECOG Performance Status at EOT (Dose Expansion Phase) Grade 1	6 participants	—	—	1 participants	—	—
Number of Participants With ECOG Performance Status at EOT (Dose Expansion Phase) Grade 2	1 participants	—	—	2 participants	—	—
Number of Participants With ECOG Performance Status at EOT (Dose Expansion Phase) Grade 4	0 participants	—	—	2 participants	—	—

PRIMARY outcome

Timeframe: OP (week 2)

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

OP was the period observed after the last dose.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=1 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=2 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at Observation Period (OP) (Week 2) Grade 0	0 participants	—	—	—	0 participants	—
Number of Participants With ECOG Performance Status at Observation Period (OP) (Week 2) Grade 1	1 participants	—	—	—	2 participants	—
Number of Participants With ECOG Performance Status at Observation Period (OP) (Week 2) Grade 3	0 participants	—	—	—	0 participants	—
Number of Participants With ECOG Performance Status at Observation Period (OP) (Week 2) Grade 2	0 participants	—	—	—	0 participants	—
Number of Participants With ECOG Performance Status at Observation Period (OP) (Week 2) Grade 4	0 participants	—	—	—	0 participants	—
Number of Participants With ECOG Performance Status at Observation Period (OP) (Week 2) Grade 5	0 participants	—	—	—	0 participants	—

PRIMARY outcome

Timeframe: OP (week 4)

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

OP was the period observed after the last dose.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=1 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=2 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at OP (Week 4) Grade 0	—	—	—	1 participants	0 participants	—
Number of Participants With ECOG Performance Status at OP (Week 4) Grade 1	—	—	—	0 participants	2 participants	—
Number of Participants With ECOG Performance Status at OP (Week 4) Grade 2	—	—	—	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at OP (Week 4) Grade 4	—	—	—	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at OP (Week 4) Grade 5	—	—	—	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at OP (Week 4) Grade 3	—	—	—	0 participants	0 participants	—

PRIMARY outcome

Timeframe: OP (week 6)

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

OP was the period observed after the last dose.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=2 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at OP (Week 6) Grade 1	—	—	—	—	2 participants	—
Number of Participants With ECOG Performance Status at OP (Week 6) Grade 2	—	—	—	—	0 participants	—
Number of Participants With ECOG Performance Status at OP (Week 6) Grade 5	—	—	—	—	0 participants	—
Number of Participants With ECOG Performance Status at OP (Week 6) Grade 0	—	—	—	—	0 participants	—
Number of Participants With ECOG Performance Status at OP (Week 6) Grade 3	—	—	—	—	0 participants	—
Number of Participants With ECOG Performance Status at OP (Week 6) Grade 4	—	—	—	—	0 participants	—

PRIMARY outcome

Timeframe: OP (week 8)

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

OP was the period observed after the last dose.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=1 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=2 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at OP (Week 8) Grade 0	—	—	—	1 participants	0 participants	—
Number of Participants With ECOG Performance Status at OP (Week 8) Grade 1	—	—	—	0 participants	2 participants	—
Number of Participants With ECOG Performance Status at OP (Week 8) Grade 2	—	—	—	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at OP (Week 8) Grade 3	—	—	—	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at OP (Week 8) Grade 4	—	—	—	0 participants	0 participants	—
Number of Participants With ECOG Performance Status at OP (Week 8) Grade 5	—	—	—	0 participants	0 participants	—

PRIMARY outcome

Timeframe: OP (week 10)

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

OP was the period observed after the last dose.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=2 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at OP (Week 10) Grade 0	—	—	—	—	0 participants	—
Number of Participants With ECOG Performance Status at OP (Week 10) Grade 1	—	—	—	—	2 participants	—
Number of Participants With ECOG Performance Status at OP (Week 10) Grade 2	—	—	—	—	0 participants	—
Number of Participants With ECOG Performance Status at OP (Week 10) Grade 3	—	—	—	—	0 participants	—
Number of Participants With ECOG Performance Status at OP (Week 10) Grade 4	—	—	—	—	0 participants	—
Number of Participants With ECOG Performance Status at OP (Week 10) Grade 5	—	—	—	—	0 participants	—

PRIMARY outcome

Timeframe: OP (week 12)

Population: SAF with available data was analyzed

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

OP was the period observed after the last dose.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=1 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at OP (Week 12) Grade 1	—	—	—	—	1 participants	—
Number of Participants With ECOG Performance Status at OP (Week 12) Grade 2	—	—	—	—	0 participants	—
Number of Participants With ECOG Performance Status at OP (Week 12) Grade 5	—	—	—	—	0 participants	—
Number of Participants With ECOG Performance Status at OP (Week 12) Grade 0	—	—	—	—	0 participants	—
Number of Participants With ECOG Performance Status at OP (Week 12) Grade 3	—	—	—	—	0 participants	—
Number of Participants With ECOG Performance Status at OP (Week 12) Grade 4	—	—	—	—	0 participants	—

SECONDARY outcome

Timeframe: From first response up to 43 months

Population: Response Analysis Set (RAS) included FAS participants and had at least 1 post baseline primary efficacy measurement. As per change in the planned analysis, the dose level utilized during the expansion phase was the RP2D, which was carefully selected from the dose escalation phase and a pooled population was used to estimate time-to-event efficacy endpoints for a comprehensive overview of the treatment's effectiveness.

DR for AML: included duration of CRc, duration of CR/complete remission with partial hematologic recovery (CRh), duration of CRh, duration of CR, and duration of response (i.e., CRc + PR).

CRh: achieved marrow blasts < 5%, partial hematologic recovery ANC ≥ 0.5 × 10^9/L and platelets ≥ 50 × 10^9/L, no evidence of extramedullary leukemia and cannot be classified as CR. The blast counts in peripheral blood was ≤ 2%.

PR for AML; achieved bone marrow regenerating normal hematopoietic cells with evidence of peripheral recovery with no (or only a few regenerating) circulating blasts with decrease of at least 50% in the percentage of blasts in bone marrow aspirate with total marrow blasts between 5% and 25%. Value ≤ 5% blasts was considered PR if Auer rods were present. No evidence of extramedullary leukemia.

CR, CRc were defined in outcome measure #3. Kaplan Meier (KM) Estimate was used.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=3 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=15 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=3 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Duration of Remission (DR) for Participants With R/R AML Duration of CRc	—	15.0 days Interval 15.0 to 15.0	—	—	—	—
Duration of Remission (DR) for Participants With R/R AML Duration of response	—	55.0 days Interval 15.0 to 55.0	—	—	—	—

SECONDARY outcome

Timeframe: From first response up to 43 months

Population: RAS As per change in the planned analysis, the dose level utilized during the expansion phase was the RP2D, which was carefully selected from the dose escalation phase and a pooled population was used to estimate time-to-event efficacy endpoints for a comprehensive overview of the treatment's effectiveness.

DR for MDS: included duration of CR and duration of response (i.e., CR + BM CR + PR).

CR, BM CR and PR achieved for minimum of 4 weeks; CR: bone marrow: ≤ 5% myeloblasts with normal maturation of all cell Lines, peripheral blood evaluation (hemoglobin (Hb) ≥ 11 g/dL, platelets ≥ 100 × 10^9/L, neutrophils ≥ 1.0 × 10^9/L, 0% blasts in blood)

BM CR: bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment

PR: achieved all CR criteria except bone marrow blasts decreased by ≥ 50% over pretreatment but still > 5%, cellularity and morphology not relevant. KM Estimate was used.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=1 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=11 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=1 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Duration of Remission (DR) for Participants With R/R Higher Risk MDS Duration of Response	—	—	—	2.0 days Data was not estimable as only 1 participant was evaluable.	—	—

SECONDARY outcome

Timeframe: From first dose up to 43 months

Population: FAS As per change in the planned analysis, the dose level utilized during the expansion phase was the RP2D, which was carefully selected from the dose escalation phase and a pooled population was used to estimate time-to-event efficacy endpoints for a comprehensive overview of the treatment's effectiveness.

EFS was defined as the time from the date of first dose until the date of documented relapse, treatment failure or death from any cause within 30 days after the last dose of study drug (whichever occurred first earliest of [relapse date, treatment failure date, death date] - first dose date + 1). Relapse was defined as a reappearance of leukemic blasts in the peripheral blood (> 2%) or ≥ 5% blasts in the bone marrow aspirate not attributable to any other cause or reappearance or new appearance of extramedullary leukemia or reappearance of significant numbers of peripheral blasts and an increase in the percentage of blasts in the bone marrow aspirate to > 25% not attributable to any other cause or reappearance or new appearance of extramedullary leukemia. KM Estimate was used.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=3 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=19 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=1 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=5 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=2 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL n=13 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Event Free Survival (EFS)	32.0 days Interval 30.0 to 50.0	58.0 days Interval 38.0 to 71.0	30.0 days Data was not estimable as only 1 participant was evaluable.	44.0 days Interval 12.0 to 81.0	NA days Interval 23.0 to Data was not estimable less than 50% participant had events.	63.0 days Interval 28.0 to 120.0

SECONDARY outcome

Timeframe: From first dose up to 43 months

Population: FAS As per change in the planned analysis, the dose level utilized during the expansion phase was the RP2D, which was carefully selected from the dose escalation phase and a pooled population was used to estimate time-to-event efficacy endpoints for a comprehensive overview of the treatment's effectiveness.

OS was defined as the time from the date of first dose until the date of death from any cause (death date - first dose date + 1). For a Participant who was not known to have died by the end of study follow-up, OS was censored at the date of last contact (date of last contact - first dose date + 1). KM Estimate was used.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=3 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=19 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=1 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=5 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=2 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL n=13 Participants Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Overall Survival (OS)	343.0 days Interval 289.0 to 532.0	162.0 days Interval 83.0 to 316.0	883.0 days Data was not estimable as only 1 participant was evaluable.	159.0 days Interval 110.0 to 482.0	88.5 days Interval 47.0 to 130.0	180.0 days Interval 82.0 to Data was not estimable less than 50% participant had events.

SECONDARY outcome

Timeframe: From first dose up to 43 months

Population: FAS with available data was analyzed.

Percentage of participants with CR was reported. CR: achieved morphologic leukemia-free state & their bone marrow was regenerating normal hematopoietic cells. If absolute neutrophil count (ANC) ≥ 1 × 10^9/L, platelet count (PC) ≥ 100 × 10^9/L, normal marrow differential < 5% blasts, & were red blood cell (RBC) and platelet transfusion independent (defined as 1 week without RBC transfusion & platelet transfusion prior to disease assessment). There was no evidence of extramedullary leukemia or Auer rods and blast counts in peripheral blood must be ≤ 2%.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=3 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=7 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=12 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=5 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
CR for Participants With R/R AML	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: From first dose up to 43 months

Population: FAS with available data was analyzed

Percentage of participants with best response (CRc + PR) was reported. CRc was defined as rate of all complete and incomplete remissions (CR + CR with incomplete platelet recovery [CRp] + CR with incomplete hematological recover [Cri]). CR, CRp and CRi were defined in Outcome measure # 3.

PR: achieved bone marrow regenerating normal hematopoietic cells with evidence of peripheral recovery with no (or only a few regenerating) circulating blasts with decrease of at least 50% in the percentage of blasts in bone marrow aspirate with total marrow blasts between 5% and 25%. Value ≤ 5% blasts was considered PR if Auer rods were present. No evidence of extramedullary leukemia.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=3 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=7 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=12 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=5 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Best Response (CRc + PR) Rates for Participants With R/R AML	0.0 percentage of participants Interval 0.0 to 63.2	28.6 percentage of participants Interval 5.3 to 65.9	25.0 percentage of participants Interval 7.2 to 52.7	0.0 percentage of participants Interval 0.0 to 45.1	—	—

SECONDARY outcome

Timeframe: From first dose up to 43 months

Population: FAS with available data was analyzed

Percentage of participants with CRh was reported. CRh: achieved marrow blasts < 5%, partial hematologic recovery ANC ≥ 0.5 × 10^9/L and platelets ≥ 50 × 10^9/L, no evidence of extramedullary leukemia and cannot be classified as CR. The blast counts in peripheral blood was ≤ 2%.

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=3 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=7 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=12 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=5 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
CRh for Participants With R/R AML	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: From first dose up to 43 months

Population: FAS with available data was analyzed.

Percentage of participants with CR was reported. CR: bone marrow: ≤ 5% myeloblasts with normal maturation of all cell Lines, peripheral blood evaluation (hemoglobin (Hb) ≥ 11 g/dL, platelets ≥ 100 × 10^9/L, neutrophils ≥ 1.0 × 10^9/L, 0% blasts in blood).

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=2 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=1 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=12 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=1 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
CR for Participants With R/R Higher Risk MDS	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: From first dose up to 43 months

Population: FAS with available data was analyzed.

Percentage of participants with HI was reported. HI: One measurement of the following for at least 8 weeks without cytotoxic therapy:

• HI-erythroid: Hb increase of ≥ 1.5 g/dL or RBC transfusions performed for Hb ≤ 9.0 g/dL)
• HI-platelets (pre-treatment PC: >20 ×10^9/L platelet, absolute increase of ≥ 30 ×10^9/L and < 20 ×10^9/L, platelet absolute increase of > 20 ×10^9/L and ≥ 100% increase from pre-treatment level
• HI-neutrophils (increase of ≥ 100% from pre-treatment level and an absolute increase of > 0.5 ×10^9/L)

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=2 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=1 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=12 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=1 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Hematologic Improvement (HI) for Participants With R/R Higher Risk MDS HI - Erythroid	0.0 percentage of participants	0.0 percentage of participants	8.3 percentage of participants	0.0 percentage of participants	—	—
Hematologic Improvement (HI) for Participants With R/R Higher Risk MDS HI - Platelets	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—	—
Hematologic Improvement (HI) for Participants With R/R Higher Risk MDS HI - Neutrophils	0.0 percentage of participants	0.0 percentage of participants	8.3 percentage of participants	0.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: From first dose up to 43 months

Population: FAS with available data was analyzed.

Percentage of participants with OR (CR + BM CR + PR + HI) was reported. CR, BM CR & PR achieved for minimum of 4 weeks.

CR: BM: ≤ 5% myeloblasts with normal maturation of all cell Lines peripheral blood evaluation (Hb) ≥ 11 g/dL platelets ≥ 100 × 10^9/L, neutrophils ≥ 1.0 × 10^9/L, 0% blasts in blood) BM CR: bone marrow ≤ 5% myeloblasts & decrease by ≥ 50% over pretreatment. PR: achieved all CR criteria except bone marrow blasts decreased ≥ 50% over pretreatment but still > 5% cellularity and morphology not relevant.

HI: One measurement of following for at least 8 weeks without cytotoxic therapy.

• HI-erythroid: Hb increase of ≥ 1.5 g/dL or RBC transfusions performed for Hb ≤ 9.0 g/dL)
• HI-platelets (pre-treatment PC: >20 ×10^9/L platelet, absolute increase of ≥ 30 ×10^9/L and < 20 ×10^9/L, platelet absolute increase of > 20 ×10^9/L and ≥ 100% increase from pre-treatment level
• HI-neutrophils (increase of ≥ 100% from pre-treatment level and an absolute increase of > 0.5 ×10^9/L)

Outcome measures

Measure	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=2 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=1 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=12 Participants Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=1 Participants Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Escalation and Expansion (MDS): ASP7517 1x10^8 Cells/mL Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle (escalation phase: 2 doses and expansion phase: 6 doses) (1 cycle= 28 days).
Objective Response (OR) (CR + BM CR + PR + HI) Rates (ORR) for Participants With R/R Higher Risk MDS	0.0 percentage of participants Interval 0.0 to 77.6	0.0 percentage of participants Interval 0.0 to 95.0	8.3 percentage of participants Interval 0.4 to 33.9	100.0 percentage of participants Interval 5.0 to 100.0	—	—

Adverse Events

Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL

Serious events: 1 serious events

Other events: 5 other events

Deaths: 6 deaths

Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL

Serious events: 4 serious events

Other events: 4 other events

Deaths: 5 deaths

Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL

Serious events: 2 serious events

Other events: 6 other events

Deaths: 7 deaths

Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL

Serious events: 8 serious events

Other events: 10 other events

Deaths: 9 deaths

Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL

Serious events: 5 serious events

Other events: 10 other events

Deaths: 5 deaths

Serious adverse events

Measure	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=6 participants at risk Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=5 participants at risk Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=8 participants at risk Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=12 participants at risk Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=12 participants at risk Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).
Blood and lymphatic system disorders Febrile neutropenia	16.7% 1/6 • Number of events 2 • From first dose up to 43 months SAF	60.0% 3/5 • Number of events 8 • From first dose up to 43 months SAF	12.5% 1/8 • Number of events 1 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	16.7% 2/12 • Number of events 2 • From first dose up to 43 months SAF
Cardiac disorders Atrial fibrillation	0.00% 0/6 • From first dose up to 43 months SAF	20.0% 1/5 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Cardiac disorders Cardiac failure	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
General disorders Pyrexia	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Infections and infestations Cellulitis	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Infections and infestations Device related infection	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Infections and infestations Pneumonia	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	16.7% 2/12 • Number of events 2 • From first dose up to 43 months SAF	16.7% 2/12 • Number of events 2 • From first dose up to 43 months SAF
Infections and infestations Pneumonia fungal	0.00% 0/6 • From first dose up to 43 months SAF	20.0% 1/5 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Infections and infestations Sepsis	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	16.7% 2/12 • Number of events 3 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Infections and infestations Septic shock	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	12.5% 1/8 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Product Issues Device physical property issue	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Psychiatric disorders Delirium	0.00% 0/6 • From first dose up to 43 months SAF	20.0% 1/5 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF

Other adverse events

Measure	Dose Escalation (Phase 1): ASP7517 1x10^6 Cells/mL n=6 participants at risk Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^6 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^7 Cells/mL n=5 participants at risk Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP7517 1x10^8 Cells/mL n=8 participants at risk Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: AML): ASP7517 1x10^8 Cells/mL n=12 participants at risk Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).	Dose Expansion (Phase 2: MDS): ASP7517 1x10^8 Cells/mL n=12 participants at risk Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 3 • From first dose up to 43 months SAF
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	25.0% 3/12 • Number of events 5 • From first dose up to 43 months SAF	16.7% 2/12 • Number of events 4 • From first dose up to 43 months SAF
Blood and lymphatic system disorders Neutropenia	0.00% 0/6 • From first dose up to 43 months SAF	20.0% 1/5 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 3 • From first dose up to 43 months SAF
Blood and lymphatic system disorders Splenomegaly	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/6 • From first dose up to 43 months SAF	20.0% 1/5 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Cardiac disorders Atrial fibrillation	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Cardiac disorders Cardiac failure	0.00% 0/6 • From first dose up to 43 months SAF	20.0% 1/5 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Gastrointestinal disorders Abdominal discomfort	0.00% 0/6 • From first dose up to 43 months SAF	20.0% 1/5 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Gastrointestinal disorders Cheilitis	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Gastrointestinal disorders Constipation	0.00% 0/6 • From first dose up to 43 months SAF	20.0% 1/5 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	16.7% 2/12 • Number of events 2 • From first dose up to 43 months SAF
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	16.7% 2/12 • Number of events 2 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Gastrointestinal disorders Haemorrhoids	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Gastrointestinal disorders Mouth haemorrhage	16.7% 1/6 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Gastrointestinal disorders Nausea	16.7% 1/6 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	16.7% 2/12 • Number of events 2 • From first dose up to 43 months SAF
Gastrointestinal disorders Oral pain	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Gastrointestinal disorders Proctitis	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Gastrointestinal disorders Stomatitis	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	12.5% 1/8 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Gastrointestinal disorders Vomiting	0.00% 0/6 • From first dose up to 43 months SAF	20.0% 1/5 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
General disorders Catheter site pain	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	12.5% 1/8 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
General disorders Chest discomfort	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
General disorders Chills	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 2 • From first dose up to 43 months SAF
General disorders Fatigue	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	25.0% 3/12 • Number of events 5 • From first dose up to 43 months SAF
General disorders Malaise	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
General disorders Non-cardiac chest pain	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
General disorders Oedema	0.00% 0/6 • From first dose up to 43 months SAF	20.0% 1/5 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	16.7% 2/12 • Number of events 2 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
General disorders Oedema peripheral	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
General disorders Pyrexia	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	12.5% 1/8 • Number of events 1 • From first dose up to 43 months SAF	25.0% 3/12 • Number of events 4 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 2 • From first dose up to 43 months SAF
Hepatobiliary disorders Liver disorder	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Infections and infestations COVID-19	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Infections and infestations Diverticulitis	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Infections and infestations Enterocolitis bacterial	0.00% 0/6 • From first dose up to 43 months SAF	20.0% 1/5 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Infections and infestations Nasopharyngitis	16.7% 1/6 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Infections and infestations Pharyngitis	16.7% 1/6 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Infections and infestations Pneumonia	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Infections and infestations Sepsis	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Injury, poisoning and procedural complications Allergic transfusion reaction	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	12.5% 1/8 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Injury, poisoning and procedural complications Extradural haematoma	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Injury, poisoning and procedural complications Fall	0.00% 0/6 • From first dose up to 43 months SAF	20.0% 1/5 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/6 • From first dose up to 43 months SAF	20.0% 1/5 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Investigations Alanine aminotransferase increased	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	12.5% 1/8 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Investigations Aspartate aminotransferase increased	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	12.5% 1/8 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Investigations Blood alkaline phosphatase increased	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	12.5% 1/8 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Investigations Blood bilirubin increased	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 5 • From first dose up to 43 months SAF
Investigations Blood creatinine increased	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	12.5% 1/8 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Investigations Blood lactate dehydrogenase increased	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Investigations Fibrin D dimer increased	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Investigations Lymphocyte count decreased	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 4 • From first dose up to 43 months SAF
Investigations Neutrophil count decreased	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 6 • From first dose up to 43 months SAF
Investigations White blood cell count decreased	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	16.7% 2/12 • Number of events 8 • From first dose up to 43 months SAF
Metabolism and nutrition disorders Decreased appetite	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/6 • From first dose up to 43 months SAF	20.0% 1/5 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	16.7% 2/12 • Number of events 2 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • From first dose up to 43 months SAF	20.0% 1/5 • Number of events 1 • From first dose up to 43 months SAF	12.5% 1/8 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	16.7% 2/12 • Number of events 3 • From first dose up to 43 months SAF
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	12.5% 1/8 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Nervous system disorders Dizziness	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Nervous system disorders Headache	0.00% 0/6 • From first dose up to 43 months SAF	20.0% 1/5 • Number of events 1 • From first dose up to 43 months SAF	12.5% 1/8 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Nervous system disorders Occipital neuralgia	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Nervous system disorders Paraesthesia	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 2 • From first dose up to 43 months SAF
Psychiatric disorders Insomnia	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	25.0% 2/8 • Number of events 2 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	16.7% 2/12 • Number of events 2 • From first dose up to 43 months SAF
Renal and urinary disorders Haematuria	16.7% 1/6 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • From first dose up to 43 months SAF	20.0% 1/5 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • From first dose up to 43 months SAF	20.0% 1/5 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	16.7% 2/12 • Number of events 2 • From first dose up to 43 months SAF
Respiratory, thoracic and mediastinal disorders Epistaxis	16.7% 1/6 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 2 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • From first dose up to 43 months SAF	20.0% 1/5 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Respiratory, thoracic and mediastinal disorders Pneumonitis	16.7% 1/6 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	12.5% 1/8 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Skin and subcutaneous tissue disorders Erythema	0.00% 0/6 • From first dose up to 43 months SAF	20.0% 1/5 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	16.7% 2/12 • Number of events 2 • From first dose up to 43 months SAF
Skin and subcutaneous tissue disorders Purpura	16.7% 1/6 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	12.5% 1/8 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	8.3% 1/12 • Number of events 1 • From first dose up to 43 months SAF
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	12.5% 1/8 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Skin and subcutaneous tissue disorders Urticaria	33.3% 2/6 • Number of events 3 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF
Vascular disorders Hypotension	0.00% 0/6 • From first dose up to 43 months SAF	0.00% 0/5 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	16.7% 2/12 • Number of events 2 • From first dose up to 43 months SAF
Vascular disorders Vasculitis	0.00% 0/6 • From first dose up to 43 months SAF	20.0% 1/5 • Number of events 1 • From first dose up to 43 months SAF	0.00% 0/8 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF	0.00% 0/12 • From first dose up to 43 months SAF

Additional Information

Clinical Trial Disclosure

Astellas Pharma Global Development Inc

Phone: 8008887704

Email: astellas.resultsdisclosure@astellas.com

Results disclosure agreements

• Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement
• Publication restrictions are in place

Restriction type: OTHER