Trial Outcomes & Findings for Study of ProTmune for Allogeneic HCT in Adult Patients With Hematologic Malignancies (NCT NCT02743351)

Last Updated: 2023-02-08

Results Overview

Acute GvHD (aGvHD) is assessed by assigning the clinical stage for the target organs (skin, liver, and gut) along with assigning an overall grade based on the minimum degree of organ involvement required to confer that grade. Grade II is defined as Stage 1 skin, Stage 1 liver, or Stage 1 GI; Grade III is defined as any Stage 1-3 skin, and Stage 2-3 liver, or Stage 2-4 GI; Grade IV is defined as Stage 4 skin, or Stage 4 liver and any Stage GI. A higher overall grade indicates a more severe outcome. The cumulative incidence of CIBMTR Grade II to IV aGVHD through approximately 100 days following HCT is measured by the percentage of participants who experienced grade II to IV aGVHD. The cumulative incidence and the associated 95% confidence interval are estimated using a competing risk analysis with death and relapse without grade II-IV aGvHD as a competing risk.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

96 participants

Primary outcome timeframe

100 days post-HCT

Results posted on

2023-02-08

Participant Flow

Participant milestones

Participant milestones
Measure	Phase I ProTmune ProTmune: Ex-vivo, programmed mobilized peripheral blood (mPB) cells	Phase 2 ProTmune ProTmune: Ex-vivo, programmed mobilized peripheral blood (mPB) cells	Phase 2 Control Control Arm: Untreated mobilized peripheral blood (mPB) cells
Overall Study STARTED	7	45	44
Overall Study COMPLETED	7	35	36
Overall Study NOT COMPLETED	0	10	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

For Phase 2, one participant in each group (ProTmune and Control) diagnosis date was not available.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I ProTmune n=7 Participants ProTmune: Ex-vivo, programmed mobilized peripheral blood (mPB) cells	Phase 2 ProTmune n=45 Participants ProTmune: Ex-vivo, programmed mobilized peripheral blood (mPB) cells	Phase 2 Control n=44 Participants Control Arm: Untreated mobilized peripheral blood (mPB) cells	Total n=96 Participants Total of all reporting groups
Age, Continuous	56.4 years STANDARD_DEVIATION 12.35 • n=7 Participants	52.4 years STANDARD_DEVIATION 13.07 • n=45 Participants	50.7 years STANDARD_DEVIATION 15.10 • n=44 Participants	51.9 years STANDARD_DEVIATION 13.94 • n=96 Participants
Sex: Female, Male Female	5 Participants n=7 Participants	13 Participants n=45 Participants	23 Participants n=44 Participants	41 Participants n=96 Participants
Sex: Female, Male Male	2 Participants n=7 Participants	32 Participants n=45 Participants	21 Participants n=44 Participants	55 Participants n=96 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=7 Participants	0 Participants n=45 Participants	3 Participants n=44 Participants	3 Participants n=96 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=7 Participants	45 Participants n=45 Participants	41 Participants n=44 Participants	93 Participants n=96 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=7 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=96 Participants
Time from initial diagnosis of primary disease (months)	5.4 months STANDARD_DEVIATION 1.3 • n=7 Participants • For Phase 2, one participant in each group (ProTmune and Control) diagnosis date was not available.	7.3 months STANDARD_DEVIATION 7.12 • n=44 Participants • For Phase 2, one participant in each group (ProTmune and Control) diagnosis date was not available.	8.4 months STANDARD_DEVIATION 12.39 • n=43 Participants • For Phase 2, one participant in each group (ProTmune and Control) diagnosis date was not available.	7.6 months STANDARD_DEVIATION 9.67 • n=94 Participants • For Phase 2, one participant in each group (ProTmune and Control) diagnosis date was not available.

PRIMARY outcome

Timeframe: 100 days post-HCT

Population: Modified intent-to-treat (mITT) population * Phase 1: All subjects who received ProTmune * Phase 2: All randomized subjects who received Investigational Product (ProTmune or Control mPB units)

Outcome measures

Outcome measures
Measure	Phase I ProTmune n=7 Participants Subjects with an available 8/8 human leukocyte antigen (HLA)-A, -B, -C, and -DRB1-matched unrelated peripheral blood cell donor who received 1 unit of ProTmune ex vivo programmed mPB cells.	Phase 2 ProTmune n=40 Participants Subjects with an available 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated peripheral blood cell donor who were randomized to received 1 unit of ProTmune ex vivo programmed mPB cells.	Phase 2 Control n=41 Participants Subjects with an available 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated peripheral blood cell donor who were randomized to received 1 unit of unmanipulated mPB cells.
Percentage of Participants With Cumulative Incidence of Grade II to IV aGvHD Through Day +100 Based on Investigator Assessment	42.9 percentage of participants Interval 7.6 to 75.7	44.4 percentage of participants Interval 28.1 to 59.5	24.9 percentage of participants Interval 12.7 to 39.1

SECONDARY outcome

Timeframe: 365 days post-HCT

1-year GvHD-free, relapse-free survival (GRFS) is a composite endpoint in which events included Grade III to IV aGvHD, cGvHD requiring systemic immunosuppressive therapy, relapse, or death from any cause. GRFS is defined as the time from HCT to the earlier of the dates of the first documented CIBMTR Grade III-IV aGvHD, first use of systemic immunosuppressive therapy for cGvHD, first documented relapse of the underlying malignancy, or death from any cause. Subjects who are alive with no documented events for Grade III-IV aGvHD, use of systemic immunosuppressive therapy for cGvHD, relapse, or death at the data cutoff will be censored at their last visit date or follow-up on or prior to the date of one-year study completion/early discontinuation. The Kaplan-Meier estimate of the median GRFS and the 95% CI are presented

Outcome measures

Outcome measures
Measure	Phase I ProTmune n=7 Participants Subjects with an available 8/8 human leukocyte antigen (HLA)-A, -B, -C, and -DRB1-matched unrelated peripheral blood cell donor who received 1 unit of ProTmune ex vivo programmed mPB cells.	Phase 2 ProTmune n=40 Participants Subjects with an available 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated peripheral blood cell donor who were randomized to received 1 unit of ProTmune ex vivo programmed mPB cells.	Phase 2 Control n=41 Participants Subjects with an available 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated peripheral blood cell donor who were randomized to received 1 unit of unmanipulated mPB cells.
1-year GvHD-free, Relapse-free Survival (GRFS)	218.0 GRFS days Interval 37.0 to The upper limit of the 95% confidence interval is not estimable.	209.0 GRFS days Interval 140.0 to 351.0	296.0 GRFS days Interval 238.0 to The upper limit of the 95% confidence interval is not estimable.

SECONDARY outcome

Timeframe: 365 days post-HCT

Percentage of subjects alive without relapse and without moderate or severe cGvHD per NIH Consensus Criteria at Day +365

Outcome measures

Outcome measures
Measure	Phase I ProTmune n=7 Participants Subjects with an available 8/8 human leukocyte antigen (HLA)-A, -B, -C, and -DRB1-matched unrelated peripheral blood cell donor who received 1 unit of ProTmune ex vivo programmed mPB cells.	Phase 2 ProTmune n=40 Participants Subjects with an available 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated peripheral blood cell donor who were randomized to received 1 unit of ProTmune ex vivo programmed mPB cells.	Phase 2 Control n=41 Participants Subjects with an available 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated peripheral blood cell donor who were randomized to received 1 unit of unmanipulated mPB cells.
Percentage of Subjects Alive Without Relapse and Without Moderate or Severe cGvHD at Day +365 - mITT Population	42.9 percentage of participants Interval 9.9 to 81.6	65.0 percentage of participants Interval 48.3 to 79.4	53.7 percentage of participants Interval 37.4 to 69.3

Adverse Events

Phase I ProTmune

Serious events: 3 serious events

Other events: 7 other events

Deaths: 2 deaths

Phase 2 ProTmune

Serious events: 24 serious events

Other events: 40 other events

Deaths: 12 deaths

Control Arm

Serious events: 20 serious events

Other events: 41 other events

Deaths: 6 deaths

Serious adverse events

Other adverse events

Additional Information

Executive Director, Clinical Operations

Fate Therapeutics

Phone: 858.875.1800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Serious adverse events
Measure	Phase I ProTmune n=7 participants at risk Subjects with an available 8/8 human leukocyte antigen (HLA)-A, -B, -C, and -DRB1-matched unrelated peripheral blood cell donor who received 1 unit of ProTmune ex vivo programmed mPB cells. Safety population includes all subjects who received IP. Subjects in the treatment group represent the actual treatment received, regardless of the treatment the subject was allocated to receive at randomization. All-cause mortality includes measure of all deaths, due to any cause, that occurred during the study in the Intent-to-treat (ITT) population, defined as all Phase 1 subjects who received ProTmune ex vivo programmed mPB cells.	Phase 2 ProTmune n=40 participants at risk Subjects with an available 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated peripheral blood cell donor who were randomized to received 1 unit of ProTmune ex vivo programmed mPB cells. Safety population includes all subjects who received IP (ProTmune or Control). Subjects in the treatment group represent the actual treatment received, regardless of the treatment the subject was allocated to receive at randomization. All-cause mortality includes measure of all deaths, due to any cause, that occurred during the study in the Intent-to-treat (ITT) population, defined as all subjects in the randomized treatment group, regardless of actual treatment received.	Control Arm n=41 participants at risk Subjects with an available 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated peripheral blood cell donor who were randomized to received 1 unit of unmanipulated mPB cells. Safety population includes all subjects who received IP (ProTmune or Control). Subjects in the treatment group represent the actual treatment received, regardless of the treatment the subject was allocated to receive at randomization. All-cause mortality includes measure of all deaths, due to any cause, that occurred during the study in the Intent-to-treat (ITT) population, defined as all subjects in the randomized treatment group, regardless of actual treatment received.
Immune system disorders Acute GVHD in intestine	28.6% 2/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	22.5% 9/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	4.9% 2/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Immune system disorders Acute GVHD in liver	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	5.0% 2/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Immune system disorders Acute GVHD in skin	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.5% 1/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Immune system disorders Chronic GVHD in intestine	14.3% 1/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	4.9% 2/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Immune system disorders Chronic GVHD in liver	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.5% 1/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Immune system disorders Engraftment syndrome	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.5% 1/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Staphylococcal bacteraemia	14.3% 1/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.5% 1/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Cellulitis	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.5% 1/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Clostridium difficile colitis	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.5% 1/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Cytomegalovirus colitis	14.3% 1/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.4% 1/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Device related infection	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.5% 1/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Enterobacter sepsis	14.3% 1/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Enterococcal infection	14.3% 1/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Escherichia bacteraemia	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.5% 1/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Klebsiella bacteraemia	14.3% 1/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Klebsiella infection	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.5% 1/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Meningoencephalitis herpetic	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.5% 1/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Parotitis	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.5% 1/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Pneumonia	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.5% 1/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.4% 1/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Pneumonia fungal	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.5% 1/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Sepsis	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.5% 1/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Sinusitis fungal	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.5% 1/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Bacterial sepsis	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.4% 1/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Corona virus infection	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.4% 1/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Enterocolitis infectious	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.4% 1/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Gastroenteritis viral	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.4% 1/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.4% 1/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Serratia bacteraemia	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.4% 1/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Renal and urinary disorders Acute kidney injury	14.3% 1/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	7.5% 3/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	4.9% 2/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Renal and urinary disorders Calculus ureteric	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.5% 1/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Renal and urinary disorders Renal colic	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.5% 1/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Renal and urinary disorders Renal failure	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.4% 1/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	5.0% 2/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.5% 1/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.5% 1/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	14.3% 1/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.5% 1/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.4% 1/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	4.9% 2/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.4% 1/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.4% 1/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.

Other adverse events
Measure	Phase I ProTmune n=7 participants at risk Subjects with an available 8/8 human leukocyte antigen (HLA)-A, -B, -C, and -DRB1-matched unrelated peripheral blood cell donor who received 1 unit of ProTmune ex vivo programmed mPB cells. Safety population includes all subjects who received IP. Subjects in the treatment group represent the actual treatment received, regardless of the treatment the subject was allocated to receive at randomization. All-cause mortality includes measure of all deaths, due to any cause, that occurred during the study in the Intent-to-treat (ITT) population, defined as all Phase 1 subjects who received ProTmune ex vivo programmed mPB cells.	Phase 2 ProTmune n=40 participants at risk Subjects with an available 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated peripheral blood cell donor who were randomized to received 1 unit of ProTmune ex vivo programmed mPB cells. Safety population includes all subjects who received IP (ProTmune or Control). Subjects in the treatment group represent the actual treatment received, regardless of the treatment the subject was allocated to receive at randomization. All-cause mortality includes measure of all deaths, due to any cause, that occurred during the study in the Intent-to-treat (ITT) population, defined as all subjects in the randomized treatment group, regardless of actual treatment received.	Control Arm n=41 participants at risk Subjects with an available 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated peripheral blood cell donor who were randomized to received 1 unit of unmanipulated mPB cells. Safety population includes all subjects who received IP (ProTmune or Control). Subjects in the treatment group represent the actual treatment received, regardless of the treatment the subject was allocated to receive at randomization. All-cause mortality includes measure of all deaths, due to any cause, that occurred during the study in the Intent-to-treat (ITT) population, defined as all subjects in the randomized treatment group, regardless of actual treatment received.
Gastrointestinal disorders Stomatitis	57.1% 4/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	47.5% 19/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	53.7% 22/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Gastrointestinal disorders Nausea	42.9% 3/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	32.5% 13/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	48.8% 20/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Gastrointestinal disorders Diarrhoea	28.6% 2/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	30.0% 12/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	29.3% 12/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Gastrointestinal disorders Haemorrhoids	14.3% 1/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	15.0% 6/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	7.3% 3/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Gastrointestinal disorders Vomiting	28.6% 2/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	12.5% 5/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Gastrointestinal disorders Abdominal pain	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	15.0% 6/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	14.6% 6/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Gastrointestinal disorders Gastrooesophageal reflux disease	14.3% 1/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	12.5% 5/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	14.6% 6/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Gastrointestinal disorders Abdominal distension	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	7.5% 3/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	7.3% 3/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Gastrointestinal disorders Dysphagia	14.3% 1/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	5.0% 2/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	7.3% 3/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Gastrointestinal disorders Flatulence	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	5.0% 2/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.4% 1/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Gastrointestinal disorders Oesophagitis	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	5.0% 2/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	24.4% 10/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Gastrointestinal disorders Oral pain	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	5.0% 2/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.4% 1/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Gastrointestinal disorders Colitis	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.5% 1/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	7.3% 3/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Gastrointestinal disorders Constipation	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.5% 1/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	7.3% 3/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Gastrointestinal disorders Dry mouth	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.5% 1/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	9.8% 4/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Gastrointestinal disorders Gastritis	14.3% 1/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	14.3% 1/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Gastrointestinal disorders Dyspepsia	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	7.3% 3/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Immune system disorders Acute graft versus host disease in skin	42.9% 3/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	52.5% 21/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	36.6% 15/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Immune system disorders Chronic graft versus host disease	57.1% 4/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	45.0% 18/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	39.0% 16/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Immune system disorders Chronic graft versus host disease in skin	28.6% 2/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	35.0% 14/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	22.0% 9/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Immune system disorders Chronic graft versus host disease in liver	42.9% 3/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	22.5% 9/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	22.0% 9/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Immune system disorders Acute graft versus host disease in intestine	14.3% 1/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	25.0% 10/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	26.8% 11/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Immune system disorders Chronic graft versus host disease in intestine	42.9% 3/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	7.5% 3/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	12.2% 5/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Immune system disorders Acute graft versus host disease in liver	14.3% 1/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	5.0% 2/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Blood and lymphatic system disorders Anaemia	57.1% 4/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	50.0% 20/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	19.5% 8/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Blood and lymphatic system disorders Febrile neutropenia	28.6% 2/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	42.5% 17/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	41.5% 17/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	17.5% 7/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.4% 1/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Blood and lymphatic system disorders Neutropenia	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	5.0% 2/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.4% 1/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Blood and lymphatic system disorders Anaemia macrocytic	14.3% 1/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Blood and lymphatic system disorders Pancytopenia	14.3% 1/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Blood and lymphatic system disorders Thrombotic microangiopathy	14.3% 1/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Musculoskeletal and connective tissue disorders Tendonitis	14.3% 1/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Cytomegalovirus infection	42.9% 3/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	10.0% 4/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	4.9% 2/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Cytomegalovirus viraemia	28.6% 2/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	10.0% 4/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	12.2% 5/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Viraemia	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	15.0% 6/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	7.3% 3/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Clostridium difficile colitis	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	12.5% 5/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	0.00% 0/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Clostridium difficile infection	14.3% 1/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	7.5% 3/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	4.9% 2/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Upper respiratory tract infection	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	10.0% 4/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	7.3% 3/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.
Infections and infestations Epstein-Barr viraemia	0.00% 0/7 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	7.5% 3/40 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.	2.4% 1/41 • From first dose of investigational product up to 730 days post-HCT Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.