Immune Thrombocytopenia (ITP)Phase 1POPULUS-1NCT07765966
Phase 1 Dose Escalation Study of RXIM002 in Autoimmune Cytopenias
A Phase 1 study testing RXIM002 in people with Immune Thrombocytopenia (ITP), run by RiboX Therapeutics Ltd..
Trial summary
The Phase 1 is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of RXIM002 in patients with relapsed or refractory autoimmune cytopenias. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Immune Thrombocytopenia (ITP)
- What is being tested?
- RXIM002
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2027to 31 Dec 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years of age
- Diagnosed with primary ITP
- Relapsed or refractory ITP
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
The Phase 1 is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of RXIM002 in patients with relapsed or refractory autoimmune cytopenias.
- Conditions
- Immune Thrombocytopenia (ITP)
- Being tested
- RXIM002
- Keywords
- Relapsed or refractory autoimmune cytopenias, Immune Thrombocytopenia (ITP), Circular ribonucleic acid, Chimeric Antigen Receptor (CAR), Anti-human CD19, in vivo CAR-T therapy
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RXIM002Biological
Targeted lipid nanoparticle (tLNP)-delivered circular ribonucleic acid (circRNA) encoding an anti-human CD19 chimeric antigen receptor (CAR)
| Study group | Role | What they receive |
|---|---|---|
| RXIM002 | Experimental | Open-label, single arm with 3 dose-level cohorts of RXIM002 Receives: Biological: RXIM002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent adverse events
Measured: Up to 104 weeks
Dose-limiting toxicities (DLTs)
Dose-limiting toxicities (DLTs)
Measured: Through Day 28 post-first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Feb 2027 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Thrombocytopenia (ITP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, single-arm
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RiboX Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765966
- Sponsor's protocol ID
- RX-AID-CS102
- Acronym
- POPULUS-1
- Status last verified
- Sep 2026
- First submitted
- 10 Aug 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No