Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CLBS03 Low Dose · 1 trial · 1 indication
The area-under-curve of sequential C-peptide concentrations (AUC-Cpep) during the mixed-meal tolerance test (MMTT) is the gold-standard method to assess residual beta-cell (ie, insulin) secretion in type 1 diabetes.
| Arm | Type | Description |
|---|---|---|
| CLBS03 Low Dose | EXPERIMENTAL | A single infusion of CLBS03 Low Dose, a cell product comprised of autologous, ex vivo expanded regulatory T-cells resuspended in sterile USP (United States Pharmacopoeia) infusion solution. |
| CLBS03 High Dose | EXPERIMENTAL | A single infusion of CLBS03 High Dose, a cell product comprised of autologous, ex vivo expanded regulatory T-cells resuspended in sterile USP infusion solution. |
| Placebo | PLACEBO_COMPARATOR | A single infusion of placebo, consisting of the infusion solution only |
| Name | Type | Description |
|---|---|---|
| CLBS03 Low Dose | BIOLOGICAL | - |
| CLBS03 High Dose | BIOLOGICAL | - |
| Placebo | BIOLOGICAL | - |
Inclusion Criteria: * Male and females aged 8 to 17 years of age * Diagnosis of T1DM within 100 days of receipt of study drug * Positive for at least one islet cell autoantibody * Peak MMTT-stimulated C-peptide level \> 0.2 pmol/mL (at the screening visit) * Weight of ≥30 kg * Must agree to use a r...
CLBS03 Low Dose is an investigational therapy being studied for use in Diabetes Mellitus, specifically in adolescents with recent onset type 1 diabetes. It is being developed by Lisata Therapeutics, Inc. (LSTA) and is currently in Phase 2 clinical development.
CLBS03 Low Dose is being developed by Lisata Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol LSTA. The company is conducting clinical trials to evaluate the therapy's safety and efficacy in patients with diabetes.
CLBS03 Low Dose is in Phase 2 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to determine its safety and effectiveness for treating diabetes mellitus.
CLBS03 Low Dose was evaluated in a completed Phase 2 clinical trial with NCT number NCT02691247. This study, titled 'Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes (The Sanford Project T-Rex Study)', enrolled 113 participants in the United States.
CLBS03 Low Dose is a specific dosage form of the investigational therapy CLBS03. While CLBS03 refers to the drug candidate generally, CLBS03 Low Dose specifies the particular dose level being studied in clinical trials for the treatment of diabetes mellitus.