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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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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06239636studyFirstPostDate: changed