NCT07765966

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
35mo left

Started Feb 2027

Typical duration for phase_1

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2027

Expected
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

1.4 years

First QC Date

August 10, 2026

Last Update Submit

August 10, 2026

Conditions

Relapsed or Refractory Autoimmune CytopeniasImmune Thrombocytopenia (ITP)

Keywords

Relapsed or refractory autoimmune cytopeniasImmune Thrombocytopenia (ITP)Circular ribonucleic acidChimeric Antigen Receptor (CAR)Anti-human CD19in vivo CAR-T therapy

Outcome Measures

Primary Outcomes (2)

  • Incidence of treatment-emergent adverse events

    Incidence of treatment-emergent adverse events

    Up to 104 weeks

  • Dose-limiting toxicities (DLTs)

    Dose-limiting toxicities (DLTs)

    Through Day 28 post-first dose

Study Arms (1)

RXIM002

EXPERIMENTAL

Open-label, single arm with 3 dose-level cohorts of RXIM002

Biological: RXIM002

Interventions

RXIM002BIOLOGICAL

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

RXIM002

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Diagnosed with primary ITP
  • Relapsed or refractory ITP

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

RecurrencePurpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPurpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhageSkin ManifestationsSigns and Symptoms

Central Study Contacts

RiboX Therapeutics Ltd.

CONTACT

617-999-8257RiboX_POPULUS-1_RX-AID-CS102_Study_Mailbox@ribox-tx.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open-label, single-arm
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 14, 2026

Study Start (Estimated)

February 1, 2027

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

August 14, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share