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UP421

Phase 1

Type1diabetes | Monoclonal antibody | Metabolic |Sana Biotechnology, Inc.|Last Updated: Dec 11, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment2

FDA Designations

No designations recorded

Clinical trial landscape

UP421 · 1 trial · 1 indication

Early Phase 1 1
NCT06239636First-in-human Safety Study of Hypoimmune Pancreatic Islet Transplantation in Adult Subjects With Type 1 DiabetesType1diabetes
RECRUITING2 Analytics
EARLY_PHASE1RECRUITING
First-in-human Safety Study of Hypoimmune Pancreatic Islet Transplantation in Adult Subjects With Type 1 Diabetes
Type1diabetes
NCT062396362
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Study Endpoints

Primary Endpoints

Safety as assessed by number of treatment related adverse events accoridng to CTCAE v 5.0
12 months

Number of treatment related adverse events as assessed by CTCAE v5.0

Secondary Endpoints

Immune evasion of implanted cells, as evaluated in systemic peripheral blood.
12 months
Presence of peak C-peptide >0.01 nmol/l in response to a mixed meal tolerance test
12 months
Presence of non-fasting C-peptide concentrations >0.01 nmol/l.
12 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
UP421 transplantationEXPERIMENTALIntramuscular transplantation of study product UP421

Interventions

NameTypeDescription
UP421BIOLOGICALIntramuscular transplantation with the ATMP UP421 composed of genetically modified human pancreatic islet cells
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Eligibility Criteria

Age Range30 Years to 45 Years
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:Sweden
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Frequently asked questions about UP421

What is UP421 used for in Type 1 diabetes?

UP421 is an investigational monoclonal antibody being developed for Type 1 diabetes. It is being studied in a first-in-human trial that transplants hypoimmune pancreatic islets into adult patients with Type 1 diabetes. The therapy is in early Phase 1 clinical development and is not yet approved.

Who is developing UP421?

UP421 is being developed by Sana Biotechnology, Inc., a biopharmaceutical company traded on NASDAQ under the ticker SANA. The company is conducting a Phase 1 clinical trial of UP421 in Sweden for Type 1 diabetes.

What phase is UP421 in?

UP421 is in Phase 1 clinical development. Specifically, it is being evaluated in an early Phase 1, first-in-human safety study. The trial is currently recruiting participants, and UP421 remains an investigational therapy that has not been approved by regulatory authorities.

What clinical trials is UP421 in?

UP421 is being studied in one clinical trial, NCT06239636, titled "First-in-human Safety Study of Hypoimmune Pancreatic Islet Transplantation in Adult Subjects With Type 1 Diabetes." This early Phase 1 trial is recruiting in Sweden, with an enrollment target of 2 participants aged 30 years and older.

Is UP421 the same as a hypoimmune pancreatic islet transplant?

UP421 is a monoclonal antibody used in a treatment approach that involves hypoimmune pancreatic islet transplantation. The clinical trial NCT06239636 combines UP421 with transplanted islet cells to potentially treat Type 1 diabetes. The therapy is in early Phase 1 testing.