Trial Outcomes & Findings for Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies (NCT NCT05316701)
NCT ID: NCT05316701
Last Updated: 2025-09-26
Results Overview
Event-free rate estimated at 12 months for cGFS per EAC, which is defined as the time from date of allogeneic hematopoietic cell transplantation (alloHCT) (ie, day 0) to date of death from any cause or first onset of moderate or severe chronic graft-versus-host disease (cGVHD) (graded per NIH consensus criteria), whichever was earliest, within 2 years after day 0. cGVHD was assessed and graded by EAC blinded to treatment assignment. Each participant in the study is followed for up to 730 days after transplant. Primary analysis was event driven (ie, when 56 participants had died or had moderate or severe cGVHD) and was not based on duration of follow-up. The analysis was conducted using all available data at the time that the 56th event occurred, and event-free rate at 12 months was estimated regardless of length of follow-up for individual participants. At the time of analysis, not all participants have reached 730 days of follow-up because they enrolled at different times.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
187 participants
Primary outcome timeframe
Day 0 through 730 days after transplantation
Results posted on
2025-09-26
Participant Flow
187 participants were randomized to treatment from 19 study centers, of which 182 participants were treated
Participant milestones
| Measure |
Orca-T
Orca-T administered after myeloablative conditioning followed by single-agent tacrolimus
|
Standard of Care
Unmanipulated allograft from peripheral blood of a matched donor after myeloablative conditioning followed by tacrolimus and methotrexate
|
|---|---|---|
|
Overall Study
STARTED
|
93
|
94
|
|
Overall Study
Participants Treated
|
88
|
94
|
|
Overall Study
COMPLETED
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
93
|
92
|
Reasons for withdrawal
| Measure |
Orca-T
Orca-T administered after myeloablative conditioning followed by single-agent tacrolimus
|
Standard of Care
Unmanipulated allograft from peripheral blood of a matched donor after myeloablative conditioning followed by tacrolimus and methotrexate
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Death
|
3
|
9
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
|
Overall Study
Progression/Relapse
|
14
|
9
|
|
Overall Study
Received Standard of Care
|
1
|
0
|
|
Overall Study
Ongoing
|
70
|
64
|
Baseline Characteristics
Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
Baseline characteristics by cohort
| Measure |
Orca-T
n=93 Participants
Orca-T administered after myeloablative conditioning followed by single-agent tacrolimus
|
Standard of Care
n=94 Participants
Unmanipulated allograft from peripheral blood of a matched donor after myeloablative conditioning followed by tacrolimus and methotrexate
|
Total
n=187 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
93 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
93 participants
n=5 Participants
|
94 participants
n=7 Participants
|
187 participants
n=5 Participants
|
|
Primary Disease
Acute Lymphoid Leukemia (ALL)
|
30 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Primary Disease
Acute Myeloid Leukemia (AML)
|
49 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Primary Disease
High-risk Myelodysplastic Syndrome (MDS)
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Primary Disease
Mixed Phenotype Acute Leukemia (MPAL)
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 through 730 days after transplantationPopulation: ITT
Event-free rate estimated at 12 months for cGFS per EAC, which is defined as the time from date of allogeneic hematopoietic cell transplantation (alloHCT) (ie, day 0) to date of death from any cause or first onset of moderate or severe chronic graft-versus-host disease (cGVHD) (graded per NIH consensus criteria), whichever was earliest, within 2 years after day 0. cGVHD was assessed and graded by EAC blinded to treatment assignment. Each participant in the study is followed for up to 730 days after transplant. Primary analysis was event driven (ie, when 56 participants had died or had moderate or severe cGVHD) and was not based on duration of follow-up. The analysis was conducted using all available data at the time that the 56th event occurred, and event-free rate at 12 months was estimated regardless of length of follow-up for individual participants. At the time of analysis, not all participants have reached 730 days of follow-up because they enrolled at different times.
Outcome measures
| Measure |
Orca-T
n=93 Participants
Orca-T administered after myeloablative conditioning followed by single-agent tacrolimus
|
Standard of Care
n=94 Participants
Unmanipulated allograft from peripheral blood of a matched donor after myeloablative conditioning followed by tacrolimus and methotrexate
|
|---|---|---|
|
Event-free at 12 Months for Moderate or Severe Chronic Graft-versus-Host-Disease-free Survival (cGFS) Per Endpoint Adjudication Committee (EAC)
|
78.0 Percentage of participants
Interval 65.0 to 86.6
|
38.4 Percentage of participants
Interval 26.2 to 50.5
|
SECONDARY outcome
Timeframe: Day 0 through 730 days after transplantationPopulation: ITT
Event rate estimated at 12 months for time from alloHCT to first onset of moderate or severe cGVHD defined by NIH consensus criteria within 2 years after day 0. Death within 2 years after day 0 without prior moderate or severe cGVHD was considered a competing event. cGVHD was assessed and graded by an independent EAC. Each participant in the study is followed for up to 730 days after transplant. The primary analysis was triggered by the 56th cGFS event (ie, when 56 participants had died or had moderate or severe chronic GVHD) and was not based on the duration of follow-up. Therefore, the analysis was conducted using all available data at the time that the 56th cGFS event occurred, and the event rate of moderate or severe cGVHD at 12 months was estimated regardless of the length of follow-up for individual participants. At the time of analysis, not all participants have reached 730 days of follow-up because they enrolled at different times.
Outcome measures
| Measure |
Orca-T
n=93 Participants
Orca-T administered after myeloablative conditioning followed by single-agent tacrolimus
|
Standard of Care
n=94 Participants
Unmanipulated allograft from peripheral blood of a matched donor after myeloablative conditioning followed by tacrolimus and methotrexate
|
|---|---|---|
|
Event Rate at 12 Months for Time to Moderate or Severe cGVHD Per EAC
|
12.6 Percentage of participants
Interval 5.3 to 23.1
|
44.0 Percentage of participants
Interval 31.3 to 56.1
|
SECONDARY outcome
Timeframe: Up to 730 days after end of enrollmentPopulation: ITT
Event-free rate estimated at 12 months for OS, which is defined as time from randomization to death from any cause. Each participant in the study is followed for up to 730 days after transplant. The analysis was triggered by the 56th cGFS event (ie, when 56 participants had died or had moderate or severe chronic GVHD) and was not based on the duration of follow-up. Therefore, the analysis was conducted using all available data at the time that the 56th cGFS event occurred, and the event-free rate of OS at 12 months was estimated regardless of the length of follow-up for individual participants. At the time of analysis, not all participants have reached 730 days of follow-up because they enrolled at different times.
Outcome measures
| Measure |
Orca-T
n=93 Participants
Orca-T administered after myeloablative conditioning followed by single-agent tacrolimus
|
Standard of Care
n=94 Participants
Unmanipulated allograft from peripheral blood of a matched donor after myeloablative conditioning followed by tacrolimus and methotrexate
|
|---|---|---|
|
Event-free at 12 Months for Overall Survival (OS)
|
93.9 Percentage of participants
Interval 85.8 to 97.4
|
83.1 Percentage of participants
Interval 72.9 to 89.8
|
SECONDARY outcome
Timeframe: Day 0 through 730 days after transplantationPopulation: ITT
Event-free rate estimated at 12 months for GRFS, which is defined as time from alloHCT to death from any cause, relapse, the first onset of grade 3 or 4 acute GVHD (graded per Mount Sinai aGVHD International Consortium \[MAGIC\] criteria), or the first onset of moderate or severe cGVHD (graded per NIH consensus criteria), whichever is earliest, within 2 years from day 0 as assessed by independent EAC. Each participant in the study is followed for up to 730 days after transplant. The analysis was triggered by the 56th cGFS event (ie, when 56 participants had died or had moderate or severe cGVHD) and not based on duration of follow-up. Therefore, analysis was conducted using all available data at the time that the 56th cGFS event occurred, and event-free rate of GRFS at 12 months was estimated regardless of length of follow-up for individual participants. At time of analysis, not all participants have reached 730 days of follow-up because they enrolled at different times.
Outcome measures
| Measure |
Orca-T
n=93 Participants
Orca-T administered after myeloablative conditioning followed by single-agent tacrolimus
|
Standard of Care
n=94 Participants
Unmanipulated allograft from peripheral blood of a matched donor after myeloablative conditioning followed by tacrolimus and methotrexate
|
|---|---|---|
|
Event-free Rate at 12 Months for Graft-versus-host Disease-free and Relapse-free Survival (GRFS) Per EAC
|
63.1 Percentage of participants
Interval 50.0 to 73.6
|
30.9 Percentage of participants
Interval 20.0 to 42.4
|
Adverse Events
Orca-T
Serious events: 34 serious events
Other events: 88 other events
Deaths: 3 deaths
Standard of Care
Serious events: 53 serious events
Other events: 94 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Orca-T
n=88 participants at risk
Orca-T administered after myeloablative conditioning followed by single-agent tacrolimus
|
Standard of Care
n=94 participants at risk
Unmanipulated allograft from peripheral blood of a matched donor after myeloablative conditioning followed by tacrolimus and methotrexate
|
|---|---|---|
|
Infections and infestations
Oral herpes
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Sepsis
|
8.0%
7/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
6.4%
6/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Bacterial sepsis
|
4.5%
4/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
4.3%
4/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Pneumonia
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
6.4%
6/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
COVID-19
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
5.3%
5/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Septic shock
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
3.2%
3/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Staphylococcal sepsis
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
3.2%
3/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
2.1%
2/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Appendicitis
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
COVID-19 pneumonia
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Device related infection
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
2.1%
2/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Influenza
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Rhinovirus infection
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
BK virus infection
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Cellulitis orbital
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Cystitis viral
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Cytomegalovirus enterocolitis
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Cytomegalovirus infection
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Escherichia sepsis
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Fungaemia
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Metapneumovirus infection
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Mycobacterium chelonae infection
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Neutropenic sepsis
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Nocardiosis
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Norovirus infection
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Perirectal abscess
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Pneumonia escherichia
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Sapovirus infection
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Shigella infection
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Urinary tract infection bacterial
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Viraemia
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Viral haemorrhagic cystitis
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Immune system disorders
Acute graft-versus-host disease
|
6.8%
6/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
12.8%
12/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Immune system disorders
Chronic graft-versus-host disease
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
6.4%
6/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Immune system disorders
Transplant rejection
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.3%
2/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
2.1%
2/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
3.2%
3/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
2.1%
2/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
2.1%
2/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Organizing pneumonia
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
2.1%
2/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal mass
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Stomatitis
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
2.1%
2/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
2.1%
2/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
2.1%
2/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
2.1%
2/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
General disorders
Pyrexia
|
5.7%
5/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
3.2%
3/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
General disorders
Mucosal inflammation
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
3.2%
3/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Vascular disorders
Hypotension
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
3.2%
3/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Vascular disorders
Distributive shock
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Vascular disorders
Embolism
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
2.1%
2/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Vascular disorders
Venous occlusion
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
3.4%
3/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Hepatobiliary disorders
Acute cholecystitis necrotic
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
2.1%
2/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Blood and lymphatic system disorders
Methaemoglobinaemia
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Renal and urinary disorders
Acute kidney injury
|
2.3%
2/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
4.3%
4/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Nervous system disorders
Depressed level of consciousness
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Nervous system disorders
Hepatic encephalopathy
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Nervous system disorders
Neuropathy peripheral
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Nervous system disorders
Presyncope
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Nervous system disorders
Seizure
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Nervous system disorders
Syncope
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Nervous system disorders
Uraemic encephalopathy
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Injury, poisoning and procedural complications
Aortic injury
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Injury, poisoning and procedural complications
Transplant failure
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Skin and subcutaneous tissue disorders
Acute generalised exanthematous pustulosis
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Psychiatric disorders
Mental status changes
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
0.00%
0/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
Other adverse events
| Measure |
Orca-T
n=88 participants at risk
Orca-T administered after myeloablative conditioning followed by single-agent tacrolimus
|
Standard of Care
n=94 participants at risk
Unmanipulated allograft from peripheral blood of a matched donor after myeloablative conditioning followed by tacrolimus and methotrexate
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
89.8%
79/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
84.0%
79/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Diarrhoea
|
80.7%
71/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
88.3%
83/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Vomiting
|
48.9%
43/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
45.7%
43/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Stomatitis
|
36.4%
32/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
53.2%
50/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Constipation
|
29.5%
26/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
37.2%
35/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Abdominal pain
|
30.7%
27/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
34.0%
32/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Dyspepsia
|
23.9%
21/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
33.0%
31/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Dry mouth
|
21.6%
19/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
16.0%
15/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Oesophagitis
|
12.5%
11/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
12.8%
12/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Haemorrhoids
|
13.6%
12/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
10.6%
10/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.0%
7/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
9.6%
9/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Proctalgia
|
8.0%
7/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
6.4%
6/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.5%
4/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
9.6%
9/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Abdominal distension
|
8.0%
7/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
5.3%
5/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Dysphagia
|
4.5%
4/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
7.4%
7/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Oral pain
|
5.7%
5/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
5.3%
5/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Colitis
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
5.3%
5/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Gastrointestinal disorders
Flatulance
|
6.8%
6/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
2.1%
2/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
55.7%
49/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
56.4%
53/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.5%
18/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
25.5%
24/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
17.0%
15/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
24.5%
23/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
17.0%
15/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
12.8%
12/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
10.2%
9/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
18.1%
17/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.8%
6/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
13.8%
13/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.8%
6/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
11.7%
11/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.5%
4/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
12.8%
12/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Metabolism and nutrition disorders
Dehydration
|
5.7%
5/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
6.4%
6/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
4.5%
4/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
5.3%
5/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.3%
2/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
5.3%
5/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Metabolism and nutrition disorders
Hypophagia
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
5.3%
5/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
5.3%
5/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
General disorders
Fatigue
|
56.8%
50/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
51.1%
48/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
General disorders
Mucosal inflammation
|
33.0%
29/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
27.7%
26/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
General disorders
Oedema peripheral
|
23.9%
21/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
27.7%
26/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
General disorders
Pyrexia
|
22.7%
20/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
23.4%
22/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
General disorders
Pain
|
4.5%
4/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
10.6%
10/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
General disorders
Chills
|
9.1%
8/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
4.3%
4/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
General disorders
Oedema
|
4.5%
4/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
7.4%
7/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
General disorders
Non-cardiac chest pain
|
6.8%
6/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
4.3%
4/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
General disorders
Chest pain
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
5.3%
5/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
52.3%
46/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
46.8%
44/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
36.4%
32/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
44.7%
42/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Blood and lymphatic system disorders
Anaemia
|
40.9%
36/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
36.2%
34/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Blood and lymphatic system disorders
Neutropenia
|
28.4%
25/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
26.6%
25/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Blood and lymphatic system disorders
Leukopenia
|
25.0%
22/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
17.0%
16/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.8%
6/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
5.3%
5/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
6.4%
6/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Sepsis
|
5.7%
5/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
3.2%
3/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
COVID-19
|
8.0%
7/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
6.4%
6/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Candida infection
|
8.0%
7/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
9.6%
9/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Oral candidiasis
|
4.5%
4/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
9.6%
9/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
BK virus infection
|
4.5%
4/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
7.4%
7/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Pneumonia
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
5.3%
5/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Rhinovirus infection
|
3.4%
3/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
7.4%
7/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Folliculitis
|
5.7%
5/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
6.4%
6/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
6.8%
6/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
4.3%
4/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Conjunctivitis
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
7.4%
7/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Infections and infestations
Skin infection
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
6.4%
6/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Nervous system disorders
Headache
|
37.5%
33/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
41.5%
39/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Nervous system disorders
Tremor
|
13.6%
12/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
20.2%
19/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Nervous system disorders
Dizziness
|
17.0%
15/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
16.0%
15/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Nervous system disorders
Dysgeusia
|
15.9%
14/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
11.7%
11/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Nervous system disorders
Neuropathy peripheral
|
9.1%
8/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
7.4%
7/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Nervous system disorders
Paraesthesia
|
5.7%
5/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
6.4%
6/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
26.1%
23/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
17.0%
16/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.0%
15/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
24.5%
23/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
22/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
14.9%
14/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.6%
12/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
10.6%
10/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.0%
7/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
11.7%
11/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.8%
6/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
9.6%
9/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.0%
7/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
9.6%
9/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.3%
2/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
8.5%
8/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.7%
5/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
4.3%
4/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
2/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
5.3%
5/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
22/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
19.1%
18/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.9%
14/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
18.1%
17/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
17.0%
15/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
9.6%
9/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
12.5%
11/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
13.8%
13/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.4%
10/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
10.6%
10/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.0%
7/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
10.6%
10/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
8.0%
7/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
5.3%
5/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.7%
5/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
1.1%
1/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Immune system disorders
Acute graft-versus-host disease
|
28.4%
25/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
35.1%
33/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Immune system disorders
Chronic graft-versus-host disease
|
14.8%
13/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
42.6%
40/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Immune system disorders
Hypogammaglobulinaemia
|
3.4%
3/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
5.3%
5/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Investigations
Blood creatinine increased
|
26.1%
23/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
23.4%
22/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Investigations
Alanine aminotransferase increased
|
14.8%
13/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
16.0%
15/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Investigations
Aspartate aminotransferase increased
|
11.4%
10/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
13.8%
13/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Investigations
Weight decreased
|
10.2%
9/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
7.4%
7/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Investigations
Blood bilirubin increased
|
5.7%
5/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
10.6%
10/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Investigations
Blood alkaline phosphatase increased
|
4.5%
4/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
5.3%
5/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.0%
15/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
11.7%
11/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.9%
14/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
12.8%
12/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.6%
12/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
8.5%
8/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.7%
5/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
4.3%
4/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.8%
6/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
2.1%
2/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.4%
3/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
5.3%
5/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Psychiatric disorders
Insomnia
|
28.4%
25/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
34.0%
32/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Psychiatric disorders
Anxiety
|
9.1%
8/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
13.8%
13/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Psychiatric disorders
Confusional state
|
1.1%
1/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
5.3%
5/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Vascular disorders
Hypertension
|
22.7%
20/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
20.2%
19/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Vascular disorders
Hypotension
|
14.8%
13/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
10.6%
10/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Vascular disorders
Orthostatic hypotension
|
4.5%
4/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
6.4%
6/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Cardiac disorders
Sinus tachycardia
|
17.0%
15/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
22.3%
21/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Cardiac disorders
Tachycardia
|
3.4%
3/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
10.6%
10/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Eye disorders
Dry eye
|
6.8%
6/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
8.5%
8/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Eye disorders
Vision blurred
|
9.1%
8/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
6.4%
6/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Eye disorders
Haematuria
|
6.8%
6/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
10.6%
10/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Eye disorders
Dysuria
|
10.2%
9/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
4.3%
4/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Eye disorders
Pollakiuria
|
6.8%
6/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
5.3%
5/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
14.8%
13/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
10.6%
10/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
4.5%
4/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
6.4%
6/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
8.5%
8/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
|
Metabolism and nutrition disorders
Decreased appetite
|
45.5%
40/88 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
50.0%
47/94 • A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place