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Frequently asked questions

TREGZI is a precision-engineered cell therapy for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen for the treatment of adults with hematological malignancies.1,2
Learn more about the types of patients included in the Precision-T clinical trial.

Conventional alloHSCT includes an undefined mix of cell types that may increase risk of complications, such as GVHD. TREGZI is a purified composition of HSPCs, Tregs, and Tcons working in sync to transform outcomes.2,3
Get more information about how TREGZI works.

TREGZI is a purified composition of HSPCs, Tregs, and Tcons working in sync to transform outcomes. With TREGZI, administration of each purified cell type is precisely timed and delivered in a specific order to promote immune tolerance, restore hematopoietic function, and minimize potential complications.2-5
Get more information about how TREGZI works.

TREGZI + Tac met the primary endpoint of superior cGFS vs conventional alloHSCT + Tac/MTX by doubling cGFS (78.0% vs 38.4%, respectively, HR=0.26 [95% CI, 0.14-0.47]).2
See more efficacy data here.

The most common adverse reactions (incidence ≥ 20%) were mucositis, diarrhea, rash, viral infections, infectious-pathogen unspecified, abdominal pain, vomiting, nausea, bacterial infections, hemorrhage, aGVHD, edema, and fungal infections.1

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.1

See more safety data here.

To enter a medical information request, please call 1-877-290-6722 to speak to an Orca Bio Medical Information representative.

Visit the Find a Center page to locate an approved treatment center or sign up for updates.

TREGZI is rolling out across the US. Visit the Find a Center page to locate an approved treatment center or sign up for updates.

MyTREGZI Support can be the first step to get answers, find financial resources for patients, or connect your patient with support to successfully complete their treatment. Support specialists can be accessed by calling 1-877-411-ORCA (select option 4) Monday to Friday, 8:00 AM to 8:00 PM Eastern Time.

 aGVHD, acute GVHD; alloHSCT, allogeneic hematopoietic stem cell transplant; cGFS, survival free from moderate-to-severe chronic GVHD; CI, confidence interval; GVHD, graft-versus-host disease; HR, hazard ratio; HSPC, hematopoietic stem and progenitor cell; MTX, methotrexate; PTCy, post-transplant cyclophosphamide; Tac, tacrolimus; Tcon, conventional T cell; Treg, regulatory T cell.
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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. 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
  3. 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
  4. Edinger M, Hoffmann P, Ermann J, et al. CD4+CD25+ regulatory T cells preserve graft-versus tumor activity while inhibiting graft-versus-host disease after bone marrow transplantation. Nat Med. 2003;9(9):1144-1150. doi:10.1038/nm915
  5. Martelli MF, Di Ianni M, Ruggeri L, et al. HLA-haploidentical transplantation with regulatory and conventional T-cell adoptive immunotherapy prevents acute leukemia relapse. Blood. 2014;124(4):638-644. doi:10.1182/blood-2014-03-564401