Phase 1 Dose Escalation Study of RXIM002 in Autoimmune Cytopenias

Phase 1Not Yet RecruitingNCT07765966

RiboX Therapeutics Ltd.27 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Immune Thrombocytopenia (ITP)

Interventions

RXIM002BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events

Time frame: Up to 104 weeks

Dose-limiting toxicities (DLTs)

Time frame: Through Day 28 post-first dose

Central Contacts

RiboX Therapeutics Ltd.

CONTACT

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

Data from ClinicalTrials.gov

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