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Also known as Velinotamig specified dose on specified days.
Velinotamig specified dose on specified days · 1 trial · 2 indications
Incidence and severity of all adverse events, serious adverse events, adverse events of special interest, adverse events leading to treatment discontinuation, and laboratory abnormalities.
| Arm | Type | Description |
|---|---|---|
| Part A: Dose Escalation. | EXPERIMENTAL | Patients with relapsing and refractory immune thrombocytopenia and warm autoimmune hemolytic anemia with velinotamig in dose escalation cohorts. |
| Part B: Dose Expansion. | EXPERIMENTAL | Patients with relapsing and refractory immune thrombocytopenia and warm autoimmune hemolytic anemia with velinotamig in dose expansion cohorts. |
| Name | Type | Description |
|---|---|---|
| Velinotamig specified dose on specified days. | DRUG | Velinotamig is an engineered bispecific antibody directed against BCMA and CD3. |
Inclusion Criteria: * Age ≥18 to 80 years * Active autoimmune cytopenia * Relapsed/refractory after standard of care therapy * ECOG performance status 2 or lower Laboratory parameters including the following: * Absolute lymphocyte count (ALC) ≥0.5 × 109/L * Absolute neutrophil count (ANC) ≥1.0 × ...
Velinotamig is an investigational small molecule being developed for the treatment of Immune Thrombocytopenia (ITP), a condition characterized by low platelet counts. It is also being studied for Warm Autoimmune Hemolytic Anemia (wAIHA). The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Velinotamig is being developed by Cullinan Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CGEM. The company is conducting clinical trials to evaluate the safety and efficacy of Velinotamig in patients with autoimmune hematologic conditions.
Velinotamig is currently in Phase 1 clinical development. It is being evaluated in a Phase 1b/2a study, though the drug remains investigational and is not yet approved for any use. The ongoing trial is designed to assess the drug's safety, tolerability, and preliminary efficacy in adults with relapsed or refractory ITP and wAIHA.
Velinotamig is being studied in a single clinical trial registered as NCT07738822, titled "A Phase 1b/2a Study of Velinotamig in Adults With Relapsed/Refractory ITP and wAIHA." This trial is not yet recruiting and plans to enroll approximately 72 participants in the United States, with a minimum age of 18 years.
Yes, Velinotamig is also referred to as "Velinotamig specified dose on specified days." This alternative name reflects the dosing regimen used in clinical studies, where the drug is administered at a specified dose on specified days. Both names refer to the same investigational drug being developed by Cullinan Therapeutics.