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Cabaletta Bio clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine and the EU Clinical Trials Information System (CTIS) — current trials in our USA, UK and EU (CTIS) registers with Cabaletta Bio as lead sponsor. Synced 26 Sep 2026
6Current trials
5Recruiting now
2Drugs in these trials
3Trial registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 — Top 14 finalist
Compiled from ClinicalTrials.gov and CTIS registry records · Last verified · Editorial standards
At a glance

Cabaletta Bio is the lead sponsor of 6 current clinical trials in our USA, UK and EU (CTIS) registers. 5 are recruiting patients now. The most common phase is Phase 1/2. The drugs named most often in its trials are CABA-201 and Endoxan. The most-studied condition is Idiopathic Inflammatory Myopathy.

ClinicalTrials.gov trials by status

  • Recruiting5100%

Trials by phase

  • Phase 1/2360%
  • Phase 2/3240%
01

Clinical trials sponsored by Cabaletta Bio

5 on ClinicalTrials.gov
StudyPhaseStatusStartRegisters
RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
NCT06154252 · Idiopathic Inflammatory Myopathy, Dermatomyositis, Anti-Synthetase Syndrome
Phase 2/3 Recruiting 2023-12 UK, USA
RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis
NCT06328777 · ClinicalTrials.gov ↗ · Systemic Sclerosis, Scleroderma, Interstitial Lung Diseases
Drug: CABA-201
Phase 2/3 Recruiting 2024-07 USA
A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV)
NCT04422912 · ClinicalTrials.gov ↗ · Pemphigus Vulgaris
Drug: CABA-201
Phase 1/2 Recruiting 2020-09 USA
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
NCT06121297 · ClinicalTrials.gov ↗ · Systemic Lupus Erythematosus, Lupus Nephritis
Drug: CABA-201
Phase 1/2 Recruiting 2024-02 USA
RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis
NCT06359041 · ClinicalTrials.gov ↗ · Generalized Myasthenia Gravis (gMG)
Drug: CABA-201
Phase 1/2 Recruiting 2024-12 USA

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Titles and statuses are copied from the registry as published.

02

Cabaletta Bio in the EU trials register (CTIS)

1 trial

Authorised or ongoing trials in the EU Clinical Trials Information System with Cabaletta Bio as sponsor. Some are the same study as a ClinicalTrials.gov record above; the two registries share no common ID. Trials with a site in Ireland are listed first.

StudyPhaseStatusCountries
A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Subjects with Active Idiopathic Inflammatory Myopathy or Active Juvenile Idiopathic Inflammatory Myopathy
2025-521145-24-01 · CTIS ↗ · Immune System Diseases
Drug: Endoxan
Phase 1 Authorised Italy, Spain, Germany
03

Drugs in Cabaletta Bio trials

2 compounds

Drugs and biologicals named as interventions in these trials, with the number of this sponsor's trials that name each one. Placebos and generic comparators are excluded.

04

Conditions in Cabaletta Bio trials

11 conditions
Idiopathic Inflammatory Myopathy1Dermatomyositis1Anti-Synthetase Syndrome1Immune-Mediated Necrotizing Myopathy1Systemic Sclerosis1Scleroderma1Interstitial Lung Diseases1Pemphigus Vulgaris1Systemic Lupus Erythematosus1Lupus Nephritis1Generalized Myasthenia Gravis (gMG)1
05

By trial register

RegisterTrialsRecruiting
Clinical trials in USA55
Clinical trials in UK11
EU register (CTIS)1—

A trial with sites in more than one country appears in each of those registers.

06

Questions about Cabaletta Bio trials

How many clinical trials does Cabaletta Bio sponsor?

Cabaletta Bio is the lead sponsor of 5 current trials on ClinicalTrials.gov in our USA and UK registers, and 1 authorised or ongoing trial in the EU register (CTIS), as of the registry sync on 26 September 2026. Completed and withdrawn studies are not counted.

Are Cabaletta Bio trials recruiting?

Yes. 5 of its 5 ClinicalTrials.gov trials are recruiting. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Which drugs is Cabaletta Bio testing?

Its current trials name 2 drugs and biologicals as interventions. The most frequent are CABA-201 (4) and Endoxan (1). The number in brackets is how many of its trials name each drug.

Where does this information come from?

Every trial, status, phase and condition on this page is copied from public ClinicalTrials.gov and EU CTIS records by a daily sync, grouped by the sponsor name each registry records. It says nothing about the organisation beyond its registered trials, and it is not medical advice.

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How this page is built

Everything on this page is copied from public registry records — it is not written from memory, and nothing here describes the organisation beyond its registered trials. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our trial registers and groups every current trial by its lead sponsor name, ignoring legal-form suffixes such as Inc. or Ltd. A small, hand-checked list joins the same organisation's different registry names (for example its EU legal entity). There is no AI drafting and no per-sponsor editorial pass. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The the registries data on this page was last retrieved on 26 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.