Trial · NCT05316701
Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
NCT05316701, Phase 3, Active not recruiting, Orca Biosystems, Inc.; results first posted 2025-09-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies. Trials, record NCT05316701. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05316701
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
- NCT number
- NCT05316701
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 187 participants, actual
- Lead sponsor
- Orca Biosystems, Inc.
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Mixed Phenotype Acute Leukemia, Undifferentiated Leukemia, Myelodysplastic Syndrome, Acute Leukemia, Therapy-Related Myelodysplastic Syndrome
- Interventions
- Orca-T, Standard-of-Care
- First posted
- 2022-04-07
- Last updated
- 2026-03-04
- Results first posted
- 2025-09-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free at 12 Months for Moderate or Severe Chronic Graft-versus-Host-Disease-free Survival (cGFS) Per Endpoint Adjudication Committee (EAC) | Day 0 through 730 days after transplantation | 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. |
| Secondary | Event Rate at 12 Months for Time to Moderate or Severe cGVHD Per EAC | Day 0 through 730 days after transplantation | 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. |
| Secondary | Event-free at 12 Months for Overall Survival (OS) | Up to 730 days after end of enrollment | 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. |
| Secondary | Event-free Rate at 12 Months for Graft-versus-host Disease-free and Relapse-free Survival (GRFS) Per EAC | Day 0 through 730 days after transplantation | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-free at 12 Months for Moderate or Severe Chronic Graft-versus-Host-Disease-free Survival (cGFS) Per Endpoint Adjudication Committee (EAC) | Day 0 through 730 days after transplantation | ITT | Percentage of participants | NUMBER |
| SECONDARY | Event Rate at 12 Months for Time to Moderate or Severe cGVHD Per EAC | Day 0 through 730 days after transplantation | ITT | Percentage of participants | NUMBER |
| SECONDARY | Event-free at 12 Months for Overall Survival (OS) | Up to 730 days after end of enrollment | ITT | Percentage of participants | NUMBER |
| SECONDARY | Event-free Rate at 12 Months for Graft-versus-host Disease-free and Relapse-free Survival (GRFS) Per EAC | Day 0 through 730 days after transplantation | ITT | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-free at 12 Months for Moderate or Severe Chronic Graft-versus-Host-Disease-free Survival (cGFS) Per Endpoint Adjudication Committee (EAC) | Orca-T | 78.0 | 95% Confidence Interval 65.0 to 86.6 | Percentage of participants | |
| Event-free at 12 Months for Moderate or Severe Chronic Graft-versus-Host-Disease-free Survival (cGFS) Per Endpoint Adjudication Committee (EAC) | Standard of Care | 38.4 | 95% Confidence Interval 26.2 to 50.5 | Percentage of participants | |
| Event Rate at 12 Months for Time to Moderate or Severe cGVHD Per EAC | Orca-T | 12.6 | 95% Confidence Interval 5.3 to 23.1 | Percentage of participants | |
| Event Rate at 12 Months for Time to Moderate or Severe cGVHD Per EAC | Standard of Care | 44.0 | 95% Confidence Interval 31.3 to 56.1 | Percentage of participants | |
| Event-free at 12 Months for Overall Survival (OS) | Orca-T | 93.9 | 95% Confidence Interval 85.8 to 97.4 | Percentage of participants | |
| Event-free at 12 Months for Overall Survival (OS) | Standard of Care | 83.1 | 95% Confidence Interval 72.9 to 89.8 | Percentage of participants | |
| Event-free Rate at 12 Months for Graft-versus-host Disease-free and Relapse-free Survival (GRFS) Per EAC | Orca-T | 63.1 | 95% Confidence Interval 50.0 to 73.6 | Percentage of participants | |
| Event-free Rate at 12 Months for Graft-versus-host Disease-free and Relapse-free Survival (GRFS) Per EAC | Standard of Care | 30.9 | 95% Confidence Interval 20.0 to 42.4 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Orca-T | 93 | |
| Overall Study | STARTED | Standard of Care | 94 | |
| Overall Study | Participants Treated | Orca-T | 88 | |
| Overall Study | Participants Treated | Standard of Care | 94 | |
| Overall Study | COMPLETED | Orca-T | 0 | |
| Overall Study | COMPLETED | Standard of Care | 2 | |
| Overall Study | NOT COMPLETED | Orca-T | 93 | |
| Overall Study | NOT COMPLETED | Standard of Care | 92 |
Source ClinicalTrials.gov
Adverse events452
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Orca-T | 79 | 88 | |
| other | Nausea | Gastrointestinal disorders | Standard of Care | 79 | 94 | |
| other | Diarrhoea | Gastrointestinal disorders | Orca-T | 71 | 88 | |
| other | Diarrhoea | Gastrointestinal disorders | Standard of Care | 83 | 94 | |
| other | Vomiting | Gastrointestinal disorders | Orca-T | 43 | 88 | |
| other | Vomiting | Gastrointestinal disorders | Standard of Care | 43 | 94 | |
| other | Stomatitis | Gastrointestinal disorders | Orca-T | 32 | 88 | |
| other | Stomatitis | Gastrointestinal disorders | Standard of Care | 50 | 94 | |
| other | Constipation | Gastrointestinal disorders | Orca-T | 26 | 88 | |
| other | Constipation | Gastrointestinal disorders | Standard of Care | 35 | 94 |
1 to 10 of 452Source ClinicalTrials.gov
See all 452 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Orca-T | 3 | 88 |
| Total, all-cause mortality | Standard of Care | 9 | 94 |
| Total, other adverse events | Orca-T | 88 | 88 |
| Total, other adverse events | Standard of Care | 94 | 94 |
| Total, serious adverse events | Orca-T | 34 | 88 |
| Total, serious adverse events | Standard of Care | 53 | 94 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Orca-T vs Standard of Care: deaths from any cause | Trial comparisons |
| Orca-T vs Standard of Care: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05316701
GET https://conductscience.org/api/trials/v1/NCT05316701/events?page=2