Introducing TREGZI

TREGZI is a revolutionary precision-engineered stem cell and T cell therapy for allogeneic transplant in adults with hematological malignancies after an appropriate myeloablative preparative regimen1

Image showing a three-dimensional illustration of an undefined mix of cell types.
Image showing a three-dimensional illustration of the 3 cell types specific to TREGZI: HSPC, Treg, and Tcon.
Image showing a three-dimensional illustration of an HSPC.
Image showing a three-dimensional illustration of a regulatory T cell.
Image showing a three-dimensional illustration of a conventional T cell.
Conventional alloHSCT

Includes an undefined mix of cell types that may increase risk of complications, such as GVHD2

TREGZI:
The precise power of 3

A purified composition of HSPCs, Tregs, and Tcons working in sync to transform outcomes3

HSPC1
  • Home to the bone marrow, engraft, self-renew, proliferate, and differentiate into all mature blood cells
  • Mature cells are released from the bone marrow, circulate in the blood stream, and migrate to tissue sites, restoring blood counts and hematopoietic function
TREG1*
  • Administered prior to Tcons to control GVHD and promote immune reconstitution
  • Nonclinical studies have shown that Tregs suppress Tcon activation and proliferation in secondary lymphoid organs and GVHD target organs, and improve immune reconstitution without compromising graft-versus-tumor effects of Tcons
  • The immunosuppressive activity of Tregs occurs through various immunoregulatory mechanisms, which help preserve immune function and decrease severity of GVHD

*The mechanism of Tregs is not fully understood.

TCON1
  • Tcons are administered after Tregs to accelerate immune reconstitution, characterized by the complete or partial restoration of peripheral blood T cell counts
  • Immune reconstitution is thought to result in graft-versus-infection and graft-versus-leukemia effects

 

TREGZI is a high-precision, allogeneic stem cell and T cell immunotherapy that is an alternative to a conventional alloHSCT transplant3
 AlloHSCT, allogeneic hematopoietic stem cell transplant; GVHD, graft-versus-host disease; HSPC, hematopoietic stem and progenitor cell; Tcon, conventional T cell; Treg, regulatory T cell.
Back: allohsct challenges Next: See TREGZI efficacy outcomes

IMPORTANT SAFETY INFORMATION AND INDICATIONS AND USAGE

ISI tray

ISI tray

INDICATIONS AND USAGE

TREGZI is indicated for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease-free survival, in the treatment of adults with hematological malignancies.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Graft Failure: Graft failure has occurred after TREGZI administration. Screen TREGZI recipients for antidonor antibodies that may prevent engraftment. Monitor patients closely for laboratory evidence of hematopoietic recovery.

Graft-Versus-Host Disease: Acute and chronic Graft-Versus-Host disease (GVHD), including life-threatening and fatal cases, occurred following treatment with TREGZI. Acute GVHD manifests as maculopapular rash, gastrointestinal symptoms, and elevated bilirubin. Chronic GVHD may include skin rash, mouth sores, dry eyes, liver inflammation, and development of scar tissue in the skin and joints and damage to the lungs. Treat patients with a single agent calcineurin inhibitor as prophylaxis to decrease the risk of GVHD. Monitor for signs and symptoms of GVHD, and treat if GVHD develops.

Infusion Reactions: Infusion reactions (IRs) may occur during or following treatment with TREGZI. Serious hypersensitivity reactions including anaphylaxis may occur to DMSO, human serum albumin (HSA), Dextran or murine protein present in TREGZI. IRs may begin within minutes of the start of TREGZI infusion, although symptoms may continue to intensify and not peak for several hours after the completion of the infusion. Monitor patients for signs and symptoms of IRs during and after TREGZI administration. When a reaction occurs, pause the infusion and institute supportive care as needed. Premedicate patients with antipyretics and histamine antagonists prior to infusion to reduce the incidence and intensity of infusion reactions.

Secondary Malignancies and Malignancies of Donor Origin: Secondary malignancies and malignancies of donor origin may occur following treatment with TREGZI. Development of secondary malignancies, including posttransplantation lymphoproliferative disorder (PTLD) may occur many years after transplantation. PTLD manifests as a lymphoma-like disease favoring non-nodal sites. PTLD is usually fatal if not treated. Serial monitoring of blood for EBV DNA may be warranted in patients with persistent cytopenias. No patient treated with TREGZI has developed PTLD. Monitor for malignancies of donor origin and secondary malignancies. Contact Orca Bio at 1-877-290-6722 if any patient is diagnosed with a secondary malignancy or a malignancy of donor origin.

Transmission of Infectious Agents: Transmission of serious infectious or communicable disease or agents may occur with TREGZI treatment as it is derived from human donor blood and manufactured using animal-derived reagents. Risks of transmission of infectious agents may occur despite screening or testing of donors. Risks of transmission of serious infections include, but are not limited to, human immunodeficiency virus, human T cell lymphotropic virus (HTLV)-1 and -2, hepatitis B virus (HBV), hepatitis C virus (HCV), Treponema pallidum, Trypanosoma cruzi, West Nile virus (WNV), cytomegalovirus, transmissible spongiform encephalopathy agents and vaccinia. Monitor patients for signs and symptoms of infections, perform tests for infectious agents and treat as clinically indicated.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥ 20%) were mucositis, diarrhea, rash, viral infections, infections – pathogen unspecified, abdominal pain, vomiting, nausea, bacterial infections, hemorrhage, aGVHD, edema, and fungal infections.

The most common Grade 3-4 laboratory abnormalities (≥ 20%) are lymphocyte count decreased, platelet count decreased, leukocyte count decreased, neutrophil count decreased and hemoglobin decreased.

INDICATIONS AND USAGE

TREGZI is indicated for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease-free survival, in the treatment of adults with hematological malignancies.

Please see accompanying full Prescribing Information.

References:

  1. TREGZITM (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq). Prescribing information. Orca Biosystems, Inc; 2026.
  2. Teipel R, Oelschlägel U, Wetzko K, et al. Differences in cellular composition of peripheral blood stem cell grafts from healthy stem cell donors mobilized with either granulocyte colony-stimulating factor (G-CSF) alone or G-CSF and plerixafor. Biol Blood Marrow Transplant. 2018;24(11):2171-2177. doi:10.1016/j.bbmt.2018.06.023
  3. Meyer E, Salhotra A, Gandhi A, et al. Orca-T versus allogeneic hematopoietic stem cell transplantation (Precision-T): a multicenter, randomized phase 3 trial. Blood. 2026;147(11):1168-1177. doi:10.1182/blood.2025031313