Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
UP421 · 1 trial · 1 indication
Number of treatment related adverse events as assessed by CTCAE v5.0
| Arm | Type | Description |
|---|---|---|
| UP421 transplantation | EXPERIMENTAL | Intramuscular transplantation of study product UP421 |
| Name | Type | Description |
|---|---|---|
| UP421 | BIOLOGICAL | Intramuscular transplantation with the ATMP UP421 composed of genetically modified human pancreatic islet cells |
Inclusion Criteria: 1. Signed informed consent for participation in the study 2. Diagnosis of type 1 diabetes mellitus (T1D); i) for ≥ 5 years and ii) diagnosed before the age of 18 years and iii) at least one or more HbA1c documented in the subject's medical journal or Swedish National...
UP421 is an investigational cell therapy being developed by Sana Biotechnology for the treatment of type 1 diabetes. It is described as a hypoimmune pancreatic islet transplantation product and is currently in early-stage clinical testing. It has not been approved by any regulatory agency and remains in clinical development.
UP421 is being studied as a treatment for type 1 diabetes. The approach involves transplanting hypoimmune pancreatic islets into adult subjects with type 1 diabetes. The goal of the research is to evaluate safety in a first-in-human setting. It is investigational and has not been approved for any use.
UP421 is being developed by Sana Biotechnology, Inc., which trades on the Nasdaq under the ticker SANA. The company is running the first-in-human study of the candidate in Sweden. Sana Biotechnology is the sponsor responsible for the clinical development program.
UP421 is in Phase 1 clinical development, specifically an early Phase 1 first-in-human study. It is not FDA approved and remains an investigational product. The program has one active trial and no completed trials. Enrollment is small, reflecting the early safety-focused stage of the research.
UP421 is being evaluated in the trial NCT06239636, titled First-in-human Safety Study of Hypoimmune Pancreatic Islet Transplantation in Adult Subjects With Type 1 Diabetes. The trial is recruiting in Sweden and has an enrollment of 2 participants. It is an early Phase 1, uncontrolled study with no randomization or blinding.
The NCT06239636 trial enrolls adults with type 1 diabetes who are 30 years of age or older. Participants of all sexes are eligible, and healthy volunteers are not accepted. The study is being conducted in Sweden and is currently recruiting. Enrollment is limited to 2 participants.