Trial Outcomes & Findings for Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia (NCT NCT00703820)

NCT ID: NCT00703820

Last Updated: 2021-08-10

Results Overview

MRD-negative is defined as \<0.1% blasts with leukemia-associated phenotype detected by flow cytometry. MRD-positive is defined as \>=0.1% blasts with leukemia-associated phenotype detected by flow cytometry.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 324 participants
• Primary outcome timeframe: Day 22 MRD measurement after one course of therapy
• Results posted on: 2021-08-10

Participant Flow

324 participants enrolled between August 2008 and March 2017.

Prior to starting the study, 62 participants were excluded for the following reasons: 29 participants were donors, 8 were determined to be ineligible (wrong diagnosis), 2 were MPAL (mixed AML) patients, and 23 were not randomized.

Participant milestones

Measure	Cytarabine+Daunorubicin+Etoposide Participants receive Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted.	Clofarabine+Cytarabine Participants receive Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted.
Overall Study STARTED	133	129
Overall Study COMPLETED	98	95
Overall Study NOT COMPLETED	35	34

Reasons for withdrawal

Measure	Cytarabine+Daunorubicin+Etoposide Participants receive Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted.	Clofarabine+Cytarabine Participants receive Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted.
Overall Study Adverse Event	12	17
Overall Study Death	5	0
Overall Study Lack of Efficacy	11	11
Overall Study Received non-protocol therapy	1	0
Overall Study Physician Decision	4	5
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia

Baseline characteristics by cohort

Measure	Cytarabine+Daunorubicin+Etoposide n=133 Participants Participants receive Cytarabine + Daunorubicin + Etoposide as a first course followed by risk-adapted therapy.	Clofarabine+Cytarabine n=129 Participants Participants receive Clofarabine + Cytarabine as a first course followed by risk-adapted therapy.	Total n=262 Participants Total of all reporting groups
Age, Continuous	9.57 years STANDARD_DEVIATION 6.00 • n=5 Participants	9.05 years STANDARD_DEVIATION 6.40 • n=7 Participants	9.31 years STANDARD_DEVIATION 6.18 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	59 Participants n=7 Participants	119 Participants n=5 Participants
Sex: Female, Male Male	73 Participants n=5 Participants	70 Participants n=7 Participants	143 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=5 Participants	17 Participants n=7 Participants	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	99 Participants n=5 Participants	110 Participants n=7 Participants	209 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) White	100 Participants n=5 Participants	81 Participants n=7 Participants	181 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 22 MRD measurement after one course of therapy

Population: Of 262 randomized patients, 242 patients were included in day 22 MRD analysis. 20 patients were excluded due to: 16 were not evaluable by flow cytometry, 2 died prior to completing the first course of therapy, 2 were off therapy for unacceptable toxicity prior to completion of one course.

MRD-negative is defined as <0.1% blasts with leukemia-associated phenotype detected by flow cytometry. MRD-positive is defined as >=0.1% blasts with leukemia-associated phenotype detected by flow cytometry.

Outcome measures

Measure	Cytarabine+Daunorubicin+Etoposide n=121 Participants Patients received Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted.	Clofarabine+Cytarabine n=121 Participants Patients received Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted.
Day 22 Minimal Residual Disease (MRD) Measured by Flow Cytometry MRD Positive	42 Participants	57 Participants
Day 22 Minimal Residual Disease (MRD) Measured by Flow Cytometry MRD Negative	79 Participants	64 Participants

SECONDARY outcome

Timeframe: 3 years after completion of therapy

Population: Randomized standard risk patients who received chemotherapy only

Kaplan-Meier estimate of the probability of being alive and free of relapse or second malignancy three years after protocol enrollment

Outcome measures

Measure	Cytarabine+Daunorubicin+Etoposide n=51 Participants Patients received Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted.	Clofarabine+Cytarabine n=41 Participants Patients received Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted.
Event-free Survival of Standard Risk Patients Who Receive Chemotherapy Alone.	55.6 Percentage of participants Interval 43.3 to 71.4	54.3 Percentage of participants Interval 40.6 to 72.5

SECONDARY outcome

Timeframe: 3 years after completion of therapy

Population: Randomized patients who received NK cell therapy after chemotherapy

Kaplan-Meier estimate of the probability of being alive and free of relapse or second malignancy three years after protocol enrollment

Outcome measures

Measure	Cytarabine+Daunorubicin+Etoposide n=9 Participants Patients received Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted.	Clofarabine+Cytarabine n=9 Participants Patients received Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted.
Event-free Survival of Standard Risk Patients Who Receive Chemotherapy Followed by Natural Killer Cell Transplantation.	55.6 Percentage of participants Interval 31.0 to 99.7	77.8 Percentage of participants Interval 54.9 to 100.0

Adverse Events

Cytarabine+Daunorubicin+Etoposide

Serious events: 127 serious events

Other events: 9 other events

Deaths: 43 deaths

Clofarabine+Cytarabine

Serious events: 122 serious events

Other events: 9 other events

Deaths: 32 deaths

Stem Cell Donors

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cytarabine+Daunorubicin+Etoposide n=133 participants at risk Participants received Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted.	Clofarabine+Cytarabine n=129 participants at risk Participants received Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted.	Stem Cell Donors n=29 participants at risk This group enrolled in the study to provide donor cells to participants. Donors did not receive therapy.
Gastrointestinal disorders Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)	1.5% 2/133 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	1.6% 2/129 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Proctitis	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Obstruction, GI, Sotmach	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Distension/bloating, abdominal	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders ALT, SGPT (serum glutamic pyruvic transaminase)	24.8% 33/133 • Number of events 47 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	37.2% 48/129 • Number of events 62 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	33.8% 45/133 • Number of events 78 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	37.2% 48/129 • Number of events 90 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders AST, SGOT (serum glutamic oxaloacetic transaminase)	15.0% 20/133 • Number of events 26 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	20.9% 27/129 • Number of events 35 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Acidosis (metabolic or respiratory)	3.0% 4/133 • Number of events 5 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	3.1% 4/129 • Number of events 4 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Allbumin, serum-low (hypoalbuminemia)	5.3% 7/133 • Number of events 10 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	3.1% 4/129 • Number of events 6 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Alkalosis (metabolic or respiratory)	1.5% 2/133 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Bilirubin (hyperbilirubinemia)	5.3% 7/133 • Number of events 7 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	8.5% 11/129 • Number of events 15 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	12.0% 16/133 • Number of events 19 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	10.9% 14/129 • Number of events 15 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Sodium, serum-high (hypernatremia)	3.0% 4/133 • Number of events 4 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	6.0% 8/133 • Number of events 8 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	6.2% 8/129 • Number of events 10 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	12.0% 16/133 • Number of events 20 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	10.9% 14/129 • Number of events 16 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Lipase	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	3.1% 4/129 • Number of events 4 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Alkaline phosphatase	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Anorexia	8.3% 11/133 • Number of events 12 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	10.1% 13/129 • Number of events 18 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders GGT (gamma-Glutamyl transpeptidase)	1.5% 2/133 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	3.9% 5/129 • Number of events 5 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Magnesium, serum-high (hypermagnesemia)	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Potassium, serum-ghigh (hyperkalemia)	1.5% 2/133 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	3.9% 5/129 • Number of events 9 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	12.8% 17/133 • Number of events 22 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	7.8% 10/129 • Number of events 14 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Dehydration	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	4.7% 6/129 • Number of events 6 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Amylase	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Tumor lysis syndrome	5.3% 7/133 • Number of events 7 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	5.4% 7/129 • Number of events 7 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Uric acid, serum-high (hyperuricemia)	2.3% 3/133 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Bicarbonate, serum-low	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Glucose, serum-low (hypoglycemia)	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Fibrinogen	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	1.6% 2/129 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Creatinine	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	2.3% 3/129 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Metabolic/Laboratory	1.5% 2/133 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	1.6% 2/129 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	1.5% 2/133 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	1.6% 2/129 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Metabolism and nutrition disorders Calcium, serum-high (hypercalcemia)	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Nausea	6.8% 9/133 • Number of events 11 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	11.6% 15/129 • Number of events 19 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Pain, throat/pharynx/larynx	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	1.6% 2/129 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam), oral cavity	3.8% 5/133 • Number of events 6 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Diarrhea	5.3% 7/133 • Number of events 7 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	10.9% 14/129 • Number of events 17 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Typhlitis (cecal inflammation)	4.5% 6/133 • Number of events 6 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	3.1% 4/129 • Number of events 4 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Vomiting	5.3% 7/133 • Number of events 8 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	12.4% 16/129 • Number of events 18 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Colitis	4.5% 6/133 • Number of events 6 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	3.9% 5/129 • Number of events 5 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Hemorrhage, GI, Oral cavity	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	2.3% 3/129 • Number of events 4 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Pain, Abdomen NOS	3.0% 4/133 • Number of events 6 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	3.9% 5/129 • Number of events 6 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Pain, Anus	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	3.1% 4/129 • Number of events 5 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Gastrointestinal - Other	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	1.6% 2/129 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Heartburn/dyspepsia	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Enteritis (inflammation of the small bowel)	2.3% 3/133 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Esophagitis	1.5% 2/133 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Hemorrhage, GI, Lower GI NOS	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic), oral cavity	3.0% 4/133 • Number of events 4 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Pain, rectum	3.8% 5/133 • Number of events 5 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Perforation, GI, appendix	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Dysphagia (difficulty swallowing)	1.5% 2/133 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Pain, oral cavity	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Pain, dental/teeth/peridontal	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Hemorrhage, GI, abdomen NOS	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Gastritis (including bile reflux gastritis)	1.5% 2/133 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Pain, stomach	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam), small bowel	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Mucotitis/stomatitis (functional/symptomatic), esophagus	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Incontinence, anal	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Gastrointestinal disorders Pain, lip	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Nervous system disorders Syncope (fainting)	1.5% 2/133 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	3.1% 4/129 • Number of events 4 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Nervous system disorders Pain, head/headache	3.0% 4/133 • Number of events 4 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	2.3% 3/129 • Number of events 5 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Nervous system disorders Neuropathy: sensory	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Nervous system disorders Hydrocephalus	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Nervous system disorders Encephalopathy	1.5% 2/133 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	2.3% 3/129 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Nervous system disorders Hemorrhage, CNS	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Nervous system disorders Neuropathy: cranial, CN VI lateral deviation of eye	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Nervous system disorders Neuropathy: motor	2.3% 3/133 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	1.6% 2/129 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Nervous system disorders Seizure	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	2.3% 3/129 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Nervous system disorders Ataxia (incoordination)	3.0% 4/133 • Number of events 4 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Nervous system disorders Speech impairment (e.g., dysphasia or aphasia)	3.8% 5/133 • Number of events 5 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Nervous system disorders CNS cerebrovascular ischemia	1.5% 2/133 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Nervous system disorders CNS necrosis/cystic progression	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Nervous system disorders Somnolence/depressed level of consciousness	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Nervous system disorders Neurology - other	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Nervous system disorders Neuropathy: cranial, CN IX Motor-pharynx; sensory-ear, pharynx, tongue	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Nervous system disorders Vasovagal episode	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Infections and infestations Infection (documented clinically or microbiologically documented, ANC<1.0x10e9/L, fever>38.5C),blood	15.0% 20/133 • Number of events 23 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	16.3% 21/129 • Number of events 24 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Infections and infestations Infection (documented clinically or microbioogically) with Grade 3 or 4 neutrophils (ANC<1.0x10e9/L)	53.4% 71/133 • Number of events 103 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	59.7% 77/129 • Number of events 115 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Infections and infestations Infection - other	1.5% 2/133 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	3.1% 4/129 • Number of events 4 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils	5.3% 7/133 • Number of events 7 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	11.6% 15/129 • Number of events 16 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Infections and infestations Colitis, infectious (e.g., Clostridium difficile)	15.8% 21/133 • Number of events 25 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	14.0% 18/129 • Number of events 18 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Infections and infestations Infection with unknown ANC, blood	2.3% 3/133 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	2.3% 3/129 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Infections and infestations Infection with unknown ANC, lung (pneumonia)	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Infections and infestations Infection with unknown ANC, urinary tract NOS	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Infections and infestations Infection with unknown ANC, catheter-related	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Infections and infestations Infection with unknown ANC, lip/perioral	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	8.3% 11/133 • Number of events 13 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	6.2% 8/129 • Number of events 8 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Immune system disorders Allergy/immunology - other	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Immune system disorders Allergic reaction to Asparaginase	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Blood and lymphatic system disorders Febrile neutropenia (fever of unknown origin: not clinically or microbiologically documented)	67.7% 90/133 • Number of events 189 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	73.6% 95/129 • Number of events 194 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Blood and lymphatic system disorders DIC (disseminated intravascular coagulation)	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Eye disorders Neutrophils/granulocytes (ANC/AGC)	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Eye disorders Retinal detachment	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Eye disorders Ocular/visual - other	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Eye disorders Ocular surface disease	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	1.6% 2/129 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Eye disorders Keratitis (corneal inflammation/corneal ulceration)	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Eye disorders Vision-photophobia	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Eye disorders Optic disc edema	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	1.6% 2/129 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
General disorders Death not associated with CTCAE term, multi-organ failure	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
General disorders Constitutional symptoms - other	0.75% 1/133 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	1.6% 2/129 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
General disorders Weight loss	2.3% 3/133 • Number of events 4 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	2.3% 3/129 • Number of events 5 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
General disorders Injection site reaction/extravasation changes	1.5% 2/133 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
General disorders Pain - other	0.75% 1/133 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0x10e9/L)	7.5% 10/133 • Number of events 10 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	4.7% 6/129 • Number of events 6 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
General disorders Edema: head and neck	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
General disorders Death not associated with CTCAE term, sudden death	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Respiratory, thoracic and mediastinal disorders Hypoxia	7.5% 10/133 • Number of events 10 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	14.7% 19/129 • Number of events 20 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Respiratory, thoracic and mediastinal disorders Pulmonary/upper respiratory - other	2.3% 3/133 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	2.3% 3/129 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	1.5% 2/133 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Respiratory, thoracic and mediastinal disorders Adult Respiratory Distress Syndrome (ARDS)	1.5% 2/133 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	3.1% 4/129 • Number of events 4 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory, nose	2.3% 3/133 • Number of events 4 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	4.7% 6/129 • Number of events 6 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory, bronchopulmonary NOS	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Respiratory, thoracic and mediastinal disorders Apnea	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Respiratory, thoracic and mediastinal disorders Hiccoughs (hiccups, singultus)	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Cardiac disorders Left ventricular systolic dysfunction	2.3% 3/133 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Cardiac disorders Valvular heart disease	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Cardiac disorders Cardiac arrhythmia - other	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Cardiac disorders Cardiac general - other	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	1.6% 2/129 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Cardiac disorders Prolonged QTc interval	2.3% 3/133 • Number of events 4 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	1.6% 2/129 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Cardiac disorders Supraventricular and nodal arrhythmia, sinus bradycardia	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	1.6% 2/129 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Cardiac disorders Right ventricular dysfunction (cor pulmonale)	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Cardiac disorders Pericardial effusion (non-malignant)	1.5% 2/133 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Cardiac disorders Left ventricular diastolic dysfunction	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Cardiac disorders Supraventricular and nodal arrhythmia, sinus tachycardia	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Skin and subcutaneous tissue disorders Rash/desquamation	5.3% 7/133 • Number of events 8 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	2.3% 3/129 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Skin and subcutaneous tissue disorders Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Skin and subcutaneous tissue disorders Dermatology/skin - other	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	1.6% 2/129 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	3.1% 4/129 • Number of events 4 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Skin and subcutaneous tissue disorders Pruritus/itching	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Skin and subcutaneous tissue disorders Pain, skin	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Skin and subcutaneous tissue disorders Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Vascular disorders Hemorrhage/bleeding - other	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Vascular disorders Hypertension	7.5% 10/133 • Number of events 12 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	3.9% 5/129 • Number of events 5 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Vascular disorders Hypotension	6.0% 8/133 • Number of events 9 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	7.0% 9/129 • Number of events 9 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Vascular disorders Thrombosis/thrombus/embolism	2.3% 3/133 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Vascular disorders Acute vascular leak syndrome	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	2.3% 3/129 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Vascular disorders Hematoma	2.3% 3/133 • Number of events 4 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Musculoskeletal and connective tissue disorders Pain, back	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Musculoskeletal and connective tissue disorders Pain, extremity-limb	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	1.6% 2/129 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Musculoskeletal and connective tissue disorders Pain, buttock	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Musculoskeletal and connective tissue disorders Pain, muscle	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	1.6% 2/129 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Musculoskeletal and connective tissue disorders Pain, joint	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Musculoskeletal and connective tissue disorders Musculoskeletal/soft tissue - other	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Musculoskeletal and connective tissue disorders Growth and development - other	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Musculoskeletal and connective tissue disorders Pain, chest wall	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy), extremity-upper	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Investigations PTT (Partial Thromboplastin Time)	1.5% 2/133 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	3.1% 4/129 • Number of events 4 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Investigations INR (International Normalized Ratio of prothrombin time)	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	1.6% 2/129 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Renal and urinary disorders Renal failure	2.3% 3/133 • Number of events 4 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	2.3% 3/129 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Renal and urinary disorders Cystitis	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Renal and urinary disorders Glomerular filtration rate	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Renal and urinary disorders Urinary frequency/urgency	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Renal and urinary disorders Renal/genitourinary - other	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Renal and urinary disorders Incontinence, urinary	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Renal and urinary disorders Urinary retention (including neurogenic bladder)	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Psychiatric disorders Mood alteration, anxiety	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Psychiatric disorders Mood alteration, depression	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Psychiatric disorders Personality/behavioral	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Psychiatric disorders Mood alteration, agitation	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Psychiatric disorders Mood alteration, euphoria	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Psychiatric disorders Confusion	1.5% 2/133 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Injury, poisoning and procedural complications Intra-operative injury - other	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Injury, poisoning and procedural complications Thrombosis/embolism (vascular access-related	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	1.6% 2/129 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Hepatobiliary disorders Liver dysfunction/failure (clinical)	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	1.6% 2/129 • Number of events 2 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Hepatobiliary disorders Hepatobiliary/pancreas - other	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Hepatobiliary disorders Cholecystitis	2.3% 3/133 • Number of events 3 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Ear and labyrinth disorders Otitis, middle ear (non-infectious)	0.00% 0/133 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.78% 1/129 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Ear and labyrinth disorders Tinnitus	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Reproductive system and breast disorders Pain, vagina	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Reproductive system and breast disorders Hemorrhage, GU, iuterus	0.75% 1/133 • Number of events 1 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/129 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.

Other adverse events

Measure	Cytarabine+Daunorubicin+Etoposide n=133 participants at risk Participants received Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted.	Clofarabine+Cytarabine n=129 participants at risk Participants received Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted.	Stem Cell Donors n=29 participants at risk This group enrolled in the study to provide donor cells to participants. Donors did not receive therapy.
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	6.8% 9/133 • Number of events 11 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	7.0% 9/129 • Number of events 10 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.	0.00% 0/29 • Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.

Additional Information

Jeffrey E. Rubnitz, MD, PhD

St. Jude Children's Research Hospital

Phone: 901-595-2388

Email: jeffrey.rubnitz@stjude.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place