Comparison · NCT05316701-sae
Orca-T vs Standard of Care: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Orca-T vs Standard of Care: serious adverse events. Trial comparisons, record NCT05316701-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05316701-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.386 | 0.291 | 0.491 | wilson | |
| Risk in group 2 | 0.564 | 0.463 | 0.66 | wilson | |
| Risk difference, group 1 minus group 2 | -0.177 | -0.312 | -0.0323 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.685 | 0.499 | 0.942 | log | |
| Odds ratio, group 1 over group 2 | 0.487 | 0.269 | 0.88 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Orca-T than on Standard of Care | 5.63 | 3.2 | 31 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Orca-T | Orca-T administered after myeloablative conditioning followed by single-agent tacrolimus | 34 | 88 | EG000 |
| Group 2 | Standard of Care | Unmanipulated allograft from peripheral blood of a matched donor after myeloablative conditioning followed by tacrolimus and methotrexate | 53 | 94 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Source ClinicalTrials.gov
Trial
- Title
- Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
- NCT number
- NCT05316701
- Phases
- PHASE3
- 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
- Lead sponsor
- Orca Biosystems, Inc.
- Results first posted
- 2025-09-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05316701?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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