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Velinotamig

Phase 1

Immune Thrombocytopenia (ITP) | Small molecule | Hematology |Cullinan Therapeutics, Inc.|Last Updated: Jul 31, 2026

Target and mechanism

ModalitySmall molecule

Also known as Velinotamig specified dose on specified days., Velinotamig specified dose on specified days

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

Velinotamig · 1 trial · 2 indications

Phase 1 1
NCT07738822A Phase 1b/2a Study of Velinotamig in Adults With Relapsed/Refractory ITP and wAIHAImmune Thrombocytopenia (ITP)
NOT YET_RECRUITING72 Analytics
PHASE1NOT YET_RECRUITING
A Phase 1b/2a Study of Velinotamig in Adults With Relapsed/Refractory ITP and wAIHA
Immune Thrombocytopenia (ITP)Unlock trial analytics

Study Endpoints

Primary Endpoints

Safety and Tolerability
48 weeks

Incidence and severity of all adverse events, serious adverse events, adverse events of special interest, adverse events leading to treatment discontinuation, and laboratory abnormalities.

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: Dose Escalation.EXPERIMENTALPatients with relapsing and refractory immune thrombocytopenia and warm autoimmune hemolytic anemia with velinotamig in dose escalation cohorts.
Part B: Dose Expansion.EXPERIMENTALPatients with relapsing and refractory immune thrombocytopenia and warm autoimmune hemolytic anemia with velinotamig in dose expansion cohorts.

Interventions

NameTypeDescription
Velinotamig specified dose on specified days.DRUGVelinotamig is an engineered bispecific antibody directed against BCMA and CD3.
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 × ...

Countries:United States
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Recent Changes (Last 90 Days)

LOWJul 31, 2026NCT07738822NEW_TRIAL: changed
LOWJul 31, 2026NCT07738822NEW_TRIAL: changed