Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GPC-100 · 1 trial · 1 indication
Determine the proportion of patients that will achieve \>=2 x 10\^6 CD34+ cells/kg in 2 leukapheresis sessions following treatment
| Arm | Type | Description |
|---|---|---|
| GPC-100 in combination with propranolol; | EXPERIMENTAL | Patients will be randomly assigned to 1 of 2 treatment arms prior to study drug administration. Approximately 40 patients will be randomized in a 1:1 ratio to the following treatment arm: • GPC-100 in combination with propranolol; or |
| GPC-100 in combination with propranolol and G-CSF | EXPERIMENTAL | Patients will be randomly assigned to 1 of 2 treatment arms prior to study drug administration. Approximately 40 patients will be randomized in a 1:1 ratio to the following treatment arm: • GPC-100 in combination with propranolol and G-CSF. |
| Name | Type | Description |
|---|---|---|
| GPC-100 | DRUG | GPC-100 is to be administered at a dose of 3.14 mg/kg GPC-100 free base via IV infusion. The corresponding volume of the reconstituted GPC-100 solution calculated based on the patient weight will be administered via IV infusion over 15 min |
| Propranolol | DRUG | propranolol |
| G-CSF | DRUG | G-CSF |
Inclusion Criteria To be eligible to participate in this study, patients must meet all the following criteria: 1. Male or female, greater than or equal to18 years of age; 2. Patients with diagnosis of MM per the International Myeloma Working Group criteria ; 3. Eligible for ASCT at the Investigato...
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GPC-100 is being developed for stem cell mobilization in patients with multiple myeloma who are undergoing autologous stem cell transplant. It is studied in combination with propranolol, with and without G-CSF, to help move stem cells from the bone marrow into the bloodstream for collection.
GPC-100 is being developed by Exicure, Inc., which trades on the Nasdaq under the ticker XCUR. Exicure is the sponsor of the clinical program evaluating GPC-100 in multiple myeloma.
GPC-100 is in Phase 2 clinical development. The Phase 2 study in multiple myeloma has been completed. GPC-100 is investigational and has not been approved by the FDA for any indication.
GPC-100 has been evaluated in one clinical trial, NCT05561751, a Phase 2 study titled "Ph2, Study to Assess the Safety and Efficacy of GPC 100 and Propranolol With and Without G-CSF for the Mobilization of Stem Cells in Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant." The trial enrolled 30 participants in the United States and is completed.
The Phase 2 trial NCT05561751 assessed GPC-100 and propranolol, with and without G-CSF, for stem cell mobilization in patients with multiple myeloma undergoing autologous stem cell transplant. It was a controlled, randomized study that enrolled 30 participants aged 18 years and older in the United States.