Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TG-0054 · 3 trials · 6 indications
Patients were all with multiple myeloma (MM), Non-Hodgkin lymphoma (NHL) or Hodgkin disease (HD). Number of patients who mobilized the targeted total number of CD34+ cells within a maximum of 4 leukapheresis sessions in study arm 1 and arm 3. Patients in arm 1 followed administration of TG-0054 (3.14 mg/kg) alone and leukapheresis start from study day 1. Patients in arm 3 followed administration of TG-0054 (3.14 mg/kg) combined with granulocyte colony-stimulating factor (G-CSF) and leukapheresis start from study day 8.
Patients who met the target CD34+ cell collection of ≧2 x 106 cells/kg after two apheresis sessions were classified as achieving mobilization success.
| Arm | Type | Description |
|---|---|---|
| TG-0054 (3.14 mg/kg) | EXPERIMENTAL | TG-0054 (3.14 mg/kg) |
| TG-0054 (2.24 mg/kg) | EXPERIMENTAL | TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) |
| Name | Type | Description |
|---|---|---|
| TG-0054 | DRUG | 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions) |
| TG-0054 (2.24 mg/kg) | DRUG | TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) |
| TG-0054 (3.14 mg/kg) | DRUG | TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) |
Inclusion Criteria: * Male or female 18 to 75 years of age inclusive; * Patients with confirmed pathology diagnosis of MM, NHL or HD; * Potential candidate for autologous stem cell transplantation at Investigator's discretion; * 4 weeks since last cycle of chemotherapy prior to the study drug admin...
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TG-0054 is an investigational small molecule being developed by Exicure, Inc. (XCUR). It has been studied in healthy volunteers and in patients with multiple myeloma, non-Hodgkin lymphoma, and Hodgkin disease. The drug is not approved and remains in clinical development.
TG-0054 has been studied for hematopoietic stem cell mobilization in patients with multiple myeloma, non-Hodgkin lymphoma, and Hodgkin disease. It has also been evaluated in healthy volunteers to assess safety, tolerability, pharmacokinetics, and efficacy.
TG-0054 is a small molecule that acts as a chemokine receptor antagonist. It is designed to mobilize hematopoietic stem cells from the bone marrow into the bloodstream, which can be collected for transplantation. This mechanism is being studied in patients with blood cancers.
TG-0054 is being developed by Exicure, Inc., a biopharmaceutical company. Exicure's stock ticker is XCUR. The company has conducted clinical trials of TG-0054 in the United States and Taiwan.
TG-0054 has completed Phase 1 and Phase 2 clinical trials. The Phase 1 trial evaluated safety and tolerability in healthy volunteers, while Phase 2 trials studied the drug in patients with multiple myeloma, non-Hodgkin lymphoma, and Hodgkin disease. It is not FDA approved.
TG-0054 has been studied in three completed trials: NCT00822341, a Phase 1 dose-escalation study in healthy volunteers; NCT01018979, a Phase 2 safety and PK/PD study in patients with multiple myeloma, non-Hodgkin lymphoma, and Hodgkin disease; and NCT01458288, a Phase 2 study of TG-0054 alone or with G-CSF in the same patient populations.