Allogeneic regulatory t cell immunotherapy with hspc and T cells

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. TREGZI™ is an allogeneic regulatory T cell-based immunotherapy with hematopoietic stem and progenitor cells and T cells 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 (cGVHD)-free survival, in the treatment of adults with hematological malignancies.

TREGZI is isolated from the mobilized peripheral blood of a donor HLA-matched to the recipient, and administered after appropriate cytoreductive conditioning. TREGZI contains purified regulatory T cells (Tregs) and conventional T cells (Tcons). The exact mechanism by which Tregs exert their effects is not fully understood. Tregs are 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 (GVT) effects of Tcons. The immunosuppressive activity of Tregs occurs through various immunoregulatory mechanisms, which help preserve immune function and decrease severity of GVHD.

For intravenous use only. Verify patient's identity prior to infusion. TREGZI is provided as 4 separate infusion bags (HSPCs, Tregs, Tcons, and Tcon diluent). Administer an appropriate myeloablative preparative regimen before infusion of TREGZI. DO NOT use a leukodepleting filter. See Full Prescribing Information for instructions on receipt, preparation, and administration of TREGZI

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Graft Failure: Monitor patients closely for laboratory evidence of hematopoietic recovery. Graft-Versus-Host Disease (GVHD): Treat patients with a single agent calcineurin inhibitor as prophylaxis to decrease the risk of GVHD. Monitor for signs and symptoms of GVHD. Infusion Reactions: Monitor patients for signs and symptoms of infusion reactions during and after TREGZI administration. When a reaction occurs, pause the infusion and institute supportive care as needed. Secondary Malignancies and Malignancies of Donor Origin: Monitor for secondary malignancies and malignancies of donor origin. Transmission of Infectious Agents: Monitor patients closely for serious infections.

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.

Store the Tregs and HSPCs in refrigerated storage at 2°C to 8°C (36°F to 46°F) until the time of use. Per institutional guidelines, Tregs and HSPCs may be kept in shipping container or moved to refrigerated storage up to the expiry time. Do not freeze. Cryopreserved TREGZI Tcons The Tcons are shipped frozen in vapor phase of liquid nitrogen at below -125°C (below -193°F). TREGZI Tcon diluent The Tcon diluent is shipped at ambient temperature (20°C to 25°C, 68°F to 77°F). Store the Tcon diluent at room temperature (18°C to 25°C, 64°F to 77°F). Once thawed and diluted, Tcons should be administered as soon as possible but within 4 hours when stored at 2°C to 8°C (36°F to 46°F).