NCT07738822

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
50mo left

Started Dec 2026

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2031

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

2.1 years

First QC Date

July 28, 2026

Last Update Submit

July 28, 2026

Conditions

Immune Thrombocytopenia (ITP)Warm Autoimmune Hemolytic Anemia (WAIHA)

Keywords

Autoimmune diseaseBlood platelet disorderThrombocytopeniaAnemiaHemolytic anemiaRed blood cell disorderAutoimmune cytopeniaWarm Autoimmune Hemolytic AnemiaImmune ThrombocytopeniaImmune Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (1)

  • 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.

    48 weeks

Study Arms (2)

Part A: Dose Escalation.

EXPERIMENTAL

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

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.

Drug: Velinotamig specified dose on specified days.

Interventions

Velinotamig specified dose on specified days.DRUG

Velinotamig is an engineered bispecific antibody directed against BCMA and CD3.

Also known as: CLN-803, GR1803
Part A: Dose Escalation.Part B: Dose Expansion.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cullinan Investigative Site

Webster, Texas, 77598, United States

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, IdiopathicAutoimmune DiseasesBlood Platelet DisordersThrombocytopeniaAnemiaAnemia, Hemolytic

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesCytopeniaHemorrhagic DisordersImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Central Study Contacts

Shane McLoughlin

CONTACT

+16178609878ClinOps@cullinantx.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2026

First Posted

July 31, 2026

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2031

Last Updated

July 31, 2026

Record last verified: 2026-07

Locations

US(1)