Phase 1 Dose Escalation Study of RXIM002 in Autoimmune Cytopenias
ConditionImmune Thrombocytopenia (ITP)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRiboX Therapeutics Ltd.
About this trial
The Phase 1 is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of RXIM002 in patients with relapsed or refractory autoimmune cytopenias.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-75 years of age
Diagnosed with primary ITP
Relapsed or refractory ITP
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
RXIM002
Biological/VaccineTargeted lipid nanoparticle (tLNP)-delivered circular ribonucleic acid (circRNA) encoding an anti-human CD19 chimeric antigen receptor (CAR)
Treatment groups
27 Participants
are divided into 1 treatment groupGroup A: RXIM002Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent adverse events
Time frame
Up to 104 weeks2
Dose-limiting toxicities (DLTs)
Dose-limiting toxicities (DLTs)
Time frame
Through Day 28 post-first doseLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: