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Not yet taking people in United StatesPhase 1/2

Velinotamig for adults with immune thrombocytopenia or warm autoimmune hemolytic anemia

Tests velinotamig injections for safety in adults with these two blood disorders.

Key facts

Who runs it
Cullinan Therapeutics Inc.
Where
Webster, United StatesSee the site
Trial code
Registry title
A Phase 1b/2a Study of Velinotamig in Adults With Relapsed/Refractory ITP and wAIHA
Status
Not yet recruiting
Phase
Phase 1/2
People taking part
72 people, planned
Starts
Dec 2026
Expected to end
Jan 2031
Type of study
Interventional, 2 groups
Treatments tested
  • Velinotamig specified dose on specified days.
Record updated
31 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with immune thrombocytopenia (ITP) or warm autoimmune hemolytic anemia (wAIHA). The disease must be active and must have come back or not responded to standard treatment.

Age
18 to 80 years
Sex
All sexes
Disease stage
Active autoimmune cytopenia (low blood cell counts caused by the immune system) that relapsed or did not respond to treatment. ECOG performance status 2 or lower, meaning you can care for yourself.
Earlier treatment
Must have had standard of care therapy before. Cannot join after previous BCMA-targeted therapy. Cannot join after an investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) before Day 1.
Biomarker or test result
Blood tests: lymphocyte count ≥0.5 × 109/L, neutrophil count ≥1.0 × 109/L, hemoglobin ≥6.5 g/dL, total bilirubin ≤1.5 × ULN, AST and ALT ≤2.0 × ULN, eGFR ≥30 mL/min/1.73m2.

Main reasons for not taking part

  • Pregnant or breastfeeding women
  • Active hepatitis B, hepatitis C, HIV, EBV or CMV infection
  • Active or latent tuberculosis, unless treatment was completed and there are no current signs
  • Heart failure of NYHA class III or IV, primary immunodeficiency or repeated infections
  • Past solid organ transplant, or major surgery planned during dosing

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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 × 109/L
  • Hemoglobin ≥6.5 g/dL
  • Total bilirubin ≤1.5 × ULN unless related to Gilbert's syndrome
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.0 × ULN, unless attributable to hemolysis
  • Estimated glomerular filtration rate (eGFR) based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥30 mL/min/1.73m2

Who cannot take part

  • Active or latent tuberculosis (TB) evidenced by a positive or indeterminate interferon gamma release assay (IGRA), unless the patient has documented previous completion of TB treatment and no current clinical indication of TB
  • Previous treatment with a BCMA-targeted therapy
  • Receipt of an investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to Day 1
  • Planned major surgery in the timeframe of the dosing period
  • History of clinically significant disease, condition, or medical history that, in the opinion of the Investigator, would interfere with subject safety, study evaluations, and/or study procedures, would put the patient at undue risk or confound study results
  • Evidence of active hepatitis B virus (HBV), hepatitis C virus (HCV), HIV, Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection
  • Presence of New York Heart Association class III or IV congestive heart
  • Primary immunodeficiency or history of recurrent infections
  • History of solid organ transplant
  • Pregnant or lactating women

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in United States

  • Webster, TexasHospital not named in the registryContact: Cullinan Investigative SiteNot yet recruiting

About the trial

What the trial wants to find out

A Phase 1b/2a, open-label dose escalation and dose expansion study of subcutaneously (SC) administered velinotamig for the treatment of adults with relapsing and refractory immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA) to evaluate safety and tolerability.

The 2 groups in the trial

  • Part A: Dose Escalation.Treatment being tested

    Patients with relapsing and refractory immune thrombocytopenia and warm autoimmune hemolytic anemia with velinotamig in dose escalation cohorts.

    Treatment: Velinotamig specified dose on specified days.

  • Part B: Dose Expansion.Treatment being tested

    Patients with relapsing and refractory immune thrombocytopenia and warm autoimmune hemolytic anemia with velinotamig in dose expansion cohorts.

    Treatment: Velinotamig specified dose on specified days.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 1b/2a, Open-label Study of Velinotamig for the Treatment of Adults With Relapsing and Refractory Immune Thrombocytopenia and Warm Autoimmune Hemolytic Anemia
Plain-language title
Velinotamig for adults with immune thrombocytopenia or warm autoimmune hemolytic anemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT07738822, who can take part
Record updated
31 July 2026