ClinicalTrials.gov record NCT07738822

A Phase 1b/2a Study of Velinotamig in Adults With Relapsed/Refractory ITP and wAIHA

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

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

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1/2A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).
Age18 years old to 80 years old
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 1b/2a, open-label study gives adults with relapsing or refractory ITP or wAIHA subcutaneous doses of velinotamig. Part A uses dose escalation; Part B expands one or more dose cohorts. The main goal is to evaluate safety and tolerability over the study period.

What it is studying. The study is testing velinotamig — an engineered bispecific antibody directed against BCMA and CD3 — given by subcutaneous injection, to evaluate its safety and tolerability in adults with relapsing or refractory ITP or wAIHA.

What the researchers hope to learn. To assess safety and tolerability of velinotamig by measuring adverse events, serious adverse events, adverse events of special interest, treatment discontinuations, and laboratory abnormalities. To evaluate these outcomes across dose-escalation and dose-expansion cohorts (primary outcome measured through 48 weeks).

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Velinotamig specified dose on specified days.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive subcutaneous (under-the-skin) doses of velinotamig in either a dose‑escalation group (Part A) or a dose‑expansion group (Part B). You will attend study visits for dosing and safety assessments, including reporting side effects and having blood tests to monitor laboratory values. The study is open-label (the treatment is known to participants and researchers) and safety and tolerability are monitored over a 48‑week time frame. The public registry record does not provide the full visit schedule or the exact dosing days.

How the study is structured. Interventional, open-label (no masking), non-randomized study in two parts. Part A is dose escalation to find tolerated doses; Part B is dose expansion at selected dose(s). Participants receive velinotamig subcutaneously. The study is Phase 1b/2a and focuses on treatment safety and tolerability.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on autoimmune hemolytic anemia

Clinical trials49 trials listed for autoimmune hemolytic anemiaEvery trial the registry lists for autoimmune hemolytic anemia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in autoimmune hemolytic anemia researchLatest monthly update: September 2026. Includes: Negative DAT cases. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
December 2026 (estimated)
Primary completion
January 2029 (estimated)
Study completion
January 2031 (estimated)
Target enrollment
72 participants (estimated)
Last updated on registry
Jul 31, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Cullinan Therapeutics Inc.

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

open-label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
dose escalation
Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.
refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
standard of care
Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
ECOG performance status
A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
Absolute neutrophil count
The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
× ULN
The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
Estimated glomerular filtration rate
A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
investigational
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
half-lives
The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
timeframe
The period over which an outcome is measured, for example 'at 12 weeks'. It is not necessarily the total length of the study.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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