Drugs / GNTI-122
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06919354 | Sep 2025 → Feb 2028 expected | type 1 diabetes mellitus | GentiBio, Inc | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2025-08-27 | GentiBio, Inc | Regulatory GentiBio Granted FDA Fast Track Designation for GNTI-122 for the Treatment of Recently Diagnosed Type 1 Diabetes gentibio.com ↗
The designation was granted, following FDA review of GNTI-122 for the treatment of recently diagnosed Type 1 Diabetes (T1D). |
| 2025-07-11 | GentiBio, Inc | Regulatory GentiBio Announces FDA Acceptance of IND for GNTI-122, a Novel Treg Cell Therapy for Recently Diagnosed Type 1 Diabetes gentibio.com ↗
GentiBio Inc., a clinical-stage biotechnology company pioneering engineered regulatory T cell (EngTreg) therapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for GNTI-122, a transformative autologous EngTreg cell therapy poised to fundamentally change the treatment paradigm for Type 1 Diabetes (T1D) patients. |
| 2025-07-01 | GentiBio, Inc | Regulatory GentiBio Receives FDA Orphan Drug Designation for GNTI-122 for the Treatment of Recently Diagnosed Type 1 Diabetes gentibio.com ↗
GentiBio, Inc., a biotechnology company pioneering engineered regulatory T cell (EngTreg) therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead investigational product, GNTI-122, for the treatment of recently diagnosed Type 1 Diabetes (T1D). |
| 2024-03-23 | GentiBio, Inc | Results GentiBio Announces Preclinical Data for GNTI-122, GentiBio’s Lead Candidate, an Autologous, Antigen-Specific Engineered T Regulatory Cell (EngTregs) for the Treatment of Newly Diagnosed and At-Risk Type 1 Diabetes (T1D) gentibio.com ↗ |
| 2022-10-11 | GentiBio, Inc | Results GentiBio Announces Preclinical Data Showing Antigen Specific Engineered Tregs Suppressing Pancreatic Inflammation and Potential Utility for Treatment and Prevention of Clinical Type 1 Diabetes (T1D) gentibio.com ↗ |
All press releases naming this drug 8 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GNTI-122 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06919354 ↗ |
| Modality | Cell therapy | “GNTI-122 is an investigational cell therapy manufactured from a participant's own blood cells” NCT06919354 ↗ |