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Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

A phase 3 trial of Orca-T in acute myeloid leukaemia and myelodysplastic syndromes / neoplasms, run by Orca Biosystems, Inc., active and no longer recruiting.

Also called: Precision-T

Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies is a phase 3 interventional study registered as NCT05316701 by Orca Biosystems, Inc., with 187 participants enrolled, started 2022-06-21 and due to reach its primary completion in 2024-07-15. Interventions recorded: Orca-T and Standard-of-Care. Results have been posted on the registry.

Setting

A Randomized Phase III Trial of Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation With Either Orca-T, a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and Regulatory T Cells, or Standard-of-Care Allogeneic Graft

Phase

Phase 3

Sponsor

Orca Biosystems, Inc.

Registry

Started

2022-06-21

Reported

2025

Enrolled

187 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

187 enrolled

Event-free at 12 Months for Moderate or Severe Chronic Graft-versus-Host-Disease-free Survival (cGFS) Per Endpoint Adjudication Committee (EAC)primarysurrogate endpoint

78 vs 38.4 out of 100 alive without the cancer coming back at 12 months with Orca-T compared with Standard of Care; 39.6 more per 100.
Roughly one extra person helped for every 3 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
Put another way, the treated group had about 74 percent lower chance of the event at any given time (hazard ratio 0.26, likely range 0.14 to 0.47).

This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.

Event-free at 12 Months for Overall Survival (OS)survival endpoint

93.9 vs 83.1 out of 100 alive at 12 months with Orca-T compared with Standard of Care; 10.8 more per 100.
Roughly one extra person helped for every 9 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
Put another way, the treated group had about 51 percent lower chance of the event at any given time (hazard ratio 0.49, likely range 0.2 to 1.22).

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

Caveats

These results apply to the people the trial enrolled: A Randomized Phase III Trial of Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation With Either Orca-T, a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and Regulatory T Cells, or Standard-of-Care Allogeneic Graft. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

187 enrolled.

Event-free at 12 Months for Moderate or Severe Chronic Graft-versus-Host-Disease-free Survival (cGFS) Per Endpoint Adjudication Committee (EAC)primary

HR 0.26 (0.14 to 0.47) · p <0.00001

Orca-T78 of 100

n = 93

Standard of Care38.4 of 100

n = 94

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95% CI 65.0 to 86.6; Figures from the ClinicalTrials.gov results section (first posted 2025-09-26), not from a publication · 95% CI 26.2 to 50.5

Event-free at 12 Months for Overall Survival (OS)

HR 0.49 (0.2 to 1.22) · p = 0.11823

Orca-T93.9 of 100

n = 93

Standard of Care83.1 of 100

n = 94

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95% CI 85.8 to 97.4; Figures from the ClinicalTrials.gov results section (first posted 2025-09-26), not from a publication · 95% CI 72.9 to 89.8

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Event-free at 12 Months for Moderate or Severe Chronic Graft-versus-Host-Disease-free Survival (cGFS) Per Endpoint Adjudication Committee (EAC)primary	Orca-T	93	78%	0.26 (0.14 to 0.47)	<0.00001	link
	Standard of Care	94	38.4%	0.26 (0.14 to 0.47)	<0.00001	link
Event-free at 12 Months for Overall Survival (OS)	Orca-T	93	93.9%	0.49 (0.2 to 1.22)	0.11823	link
Event-free at 12 Months for Overall Survival (OS)	Standard of Care	94	83.1%	0.49 (0.2 to 1.22)	0.11823	link

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cancers

Acute myeloid leukaemia Myelodysplastic syndromes / neoplasms (MDS)

technologies

Allogeneic (off-the-shelf) cell therapy

drugs

ApprovedPrecision-sorted allogeneic stem cell graft with regulatory T cells

Allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq · Tregzi

companies