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Velinotamig for Thrombocytopenic Purpura and Autoimmune Hemolytic Anemia

SM
Overseen ByShane McLoughlin
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Cullinan Therapeutics Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults who have immune thrombocytopenia (ITP) or warm autoimmune hemolytic anemia (wAIHA) that has come back or hasn't improved with previous treatments.

Inclusion Criteria

I am between 18 and 80 years old.
Absolute lymphocyte count (ALC) ≥0.5 × 10^9/L
Total bilirubin ≤1.5 × ULN unless related to Gilbert's syndrome
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Exclusion Criteria

I have severe congestive heart failure (NYHA class III or IV).
I do not have active or untreated latent tuberculosis.
History of clinically significant disease, condition, or medical history that would interfere with subject safety, study evaluations, or study procedures, or put the patient at undue risk or confound study results
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What Are the Treatments Tested in This Trial?

Interventions

  • Velinotamig

Trial Overview

The study is testing different doses of a new drug called velinotamig, given as an injection under the skin, to see if it is safe and well-tolerated in people with relapsed or hard-to-treat ITP or wAIHA.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Part B: Dose Expansion.Experimental Treatment1 Intervention
Group II: Part A: Dose Escalation.Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cullinan Therapeutics Inc.

Lead Sponsor

Trials
9
Recruited
1,000+

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