Immune Thrombocytopenia (ITP)Phase 1/2NCT07738822
A Phase 1b/2a Study of Velinotamig in Adults With Relapsed/Refractory ITP and wAIHA
A Phase 1/2 study testing Velinotamig specified dose on specified days. in people with Immune Thrombocytopenia (ITP) and Warm Autoimmune Hemolytic Anemia (WAIHA), run by Cullinan Therapeutics Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Immune Thrombocytopenia (ITP), Warm Autoimmune Hemolytic Anemia (WAIHA)
- What is being tested?
- Velinotamig specified dose on specified days.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Jan 2031
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cullinan Investigative Site
Webster, Texas, 77598
Cullinan Investigative Site, +6178609878, ClinOps@cullinantx.com
About this study
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
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.
- Being tested
- Velinotamig specified dose on specified days.
- Keywords
- Autoimmune disease, Blood platelet disorder, Thrombocytopenia, Anemia, Hemolytic anemia, Red blood cell disorder, Autoimmune cytopenia, Warm Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, Immune Thrombocytopenic Purpura
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Autoimmune Diseases, Blood Platelet Disorders, Thrombocytopenia, Anemia, Anemia, Hemolytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Velinotamig specified dose on specified days.Drug
Also called CLN-803, GR1803
Velinotamig is an engineered bispecific antibody directed against BCMA and CD3.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Dose Escalation. | Experimental | Patients with relapsing and refractory immune thrombocytopenia and warm autoimmune hemolytic anemia with velinotamig in dose escalation cohorts. Receives: Drug: Velinotamig specified dose on specified days. |
| Part B: Dose Expansion. | Experimental | Patients with relapsing and refractory immune thrombocytopenia and warm autoimmune hemolytic anemia with velinotamig in dose expansion cohorts. Receives: Drug: Velinotamig specified dose on specified days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Incidence and severity of all adverse events, serious adverse events, adverse events of special interest, adverse events leading to treatment discontinuation, and laboratory abnormalities.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study startDec 2026 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Thrombocytopenia (ITP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cullinan Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738822
- Sponsor's protocol ID
- CLN-803-AIC-101
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided