Can a bispecific antibody tame two autoimmune blood disorders?

NCT ID NCT07738822

Disease control Sponsor: Cullinan Therapeutics Inc. Source: ClinicalTrials.gov ↗

First seen Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This trial is testing an investigational drug called velinotamig in adults with immune thrombocytopenia (ITP) or warm autoimmune hemolytic anemia (wAIHA) that has relapsed or not responded to standard treatments. Velinotamig is an engineered bispecific antibody designed to target BCMA and CD3, potentially modulating the immune system. The study aims to evaluate the safety and tolerability of the drug, given as a subcutaneous injection, in a small group of participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: velinotamig (also known as CLN-803, GR1803), an engineered bispecific antibody targeting BCMA and CD3
What this could lead to: If successful, this could lead to a new treatment option for people with immune thrombocytopenia or warm autoimmune hemolytic anemia who have not responded to standard therapies.
What could go wrong: This is an early-phase trial with a small number of participants, so the drug may not prove safe or effective. Possible side effects include immune-related reactions and infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 × 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 Exclusion Criteria: * Pregnant or lactating women * 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 * 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 * Presence of New York Heart Association class III or IV congestive heart * Primary immunodeficiency or history of recurrent infections * 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 * History of solid organ transplant * Planned major surgery in the timeframe of the dosing period

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Conditions

The condition(s) this trial relates to.

anemia autoimmune disease autoimmune hemolytic anemia, warm type blood platelet disease hemolytic anemia Purpura, Thrombocytopenic, Idiopathic thrombocytopenia thrombocytopenia due to immune destruction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Immune thrombocytopenia (ITP) Warm autoimmune hemolytic anemia (waiha)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Can a bispecific antibody tame two autoimmune blood disorders?

What the study statuses mean