Phase 1 Dose Escalation Study of RXIM002 in Autoimmune Cytopenias

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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07765966

Acronym

POPULUS-1

Enrollment

Registered

2026-08-14

Start date

2027-02-01

Completion date

2029-12-31

Last updated

2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Thrombocytopenia (ITP)

Keywords

Relapsed or refractory autoimmune cytopenias, Immune Thrombocytopenia (ITP), Circular ribonucleic acid, Chimeric Antigen Receptor (CAR), Anti-human CD19, in vivo CAR-T therapy

Brief summary

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

Interventions

BIOLOGICALRXIM002

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Open-label, single-arm

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of treatment-emergent adverse events	Up to 104 weeks	Incidence of treatment-emergent adverse events
Dose-limiting toxicities (DLTs)	Through Day 28 post-first dose	Dose-limiting toxicities (DLTs)

Contacts

CONTACTRiboX Therapeutics Ltd.

RiboX_POPULUS-1_RX-AID-CS102_Study_Mailbox@ribox-tx.com617-999-8257

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026