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Also known as Velinotamig specified dose on specified days.
Velinotamig · 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 by Cullinan Therapeutics, Inc. for immune thrombocytopenia (ITP), a hematologic condition in which the immune system destroys platelets. It is in Phase 1 clinical development and is not yet approved. Velinotamig is also being studied in warm autoimmune hemolytic anemia (WAIHA).
Velinotamig is being studied for the treatment of immune thrombocytopenia (ITP), a blood disorder marked by low platelet counts. Development is at the Phase 1 stage, so Velinotamig is investigational and has not been approved for ITP or any other indication. The clinical program also includes patients with warm autoimmune hemolytic anemia.
Velinotamig is being developed by Cullinan Therapeutics, Inc., which trades on the Nasdaq under the ticker CGEM. Cullinan is the sponsor of the Phase 1b/2a study evaluating Velinotamig in adults with relapsed or refractory immune thrombocytopenia and warm autoimmune hemolytic anemia.
Velinotamig is in Phase 1 development. The ongoing study is a Phase 1b/2a trial, and Velinotamig has not been approved by the FDA or any other regulator. It remains an investigational small molecule for immune thrombocytopenia and warm autoimmune hemolytic anemia.
Velinotamig is being evaluated in one clinical trial, NCT07738822, titled a Phase 1b/2a study of Velinotamig in adults with relapsed or refractory ITP and wAIHA. The trial is not yet recruiting, plans to enroll 72 participants, is controlled, and is being conducted in the United States.
Yes. Velinotamig specified dose on specified days is an alternative name used for Velinotamig, so searches under that phrasing refer to the same investigational small molecule from Cullinan Therapeutics. Both names point to the Phase 1b/2a program in immune thrombocytopenia and warm autoimmune hemolytic anemia.