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NCT Number: NCT07765966

Phase 1 Dose Escalation Study of RXIM002 in Autoimmune Cytopenias

The Phase 1 is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of RXIM002 in patients with relapsed or refractory autoimmune cytopenias.

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Key information

Conditions

Relapsed or Refractory Autoimmune Cytopenias Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Immune Thrombocytopenia (ITP) Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Recurrence Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-75 years of age
  • Diagnosed with primary ITP
  • Relapsed or refractory ITP

Exclusion criteria

  • Allergy or hypersensitivity to messenger ribonucleic acid (mRNA) vaccines or other RNA-LNP products
  • Any active infection
  • Heart failure, reduced kidney function, or liver abnormalities

Treatment and study plan

RXIM002

Biological

Targeted lipid nanoparticle (tLNP)-delivered circular ribonucleic acid (circRNA) encoding an anti-human CD19 chimeric antigen receptor (CAR)

Primary outcomes

  1. Incidence of treatment-emergent adverse events

    Time frame: Up to 104 weeks

    Incidence of treatment-emergent adverse events

  2. Dose-limiting toxicities (DLTs)

    Time frame: Through Day 28 post-first dose

    Dose-limiting toxicities (DLTs)

Study contacts

Contact information is provided by the study sponsor or research team.

RiboX Therapeutics Ltd.

CONTACT

[email protected]

617-999-8257

Sponsors and collaborators

Lead sponsor

RiboX Therapeutics Ltd.

Industry

Registry information

Official study title

A Phase 1, Open Label, Dose Escalation Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Early Efficacy of RXIM002, in Patients With Relapsed or Refractory Autoimmune Cytopenias

Acronym: POPULUS-1

Important dates

Study start
2027
Primary completion
2028
Study completion
2029
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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