A Phase I/II Study of Eque-cel in Subjects Withimmune-mediated Necrotizing Myopathy
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanjing IASO Biotechnology Co., Ltd.
About this trial
This is an open-label, single-arm Phase I/II clinical study to evaluate the efficacy and safety of Eque-cel Injection in patients with refractory immune-mediated necrotizing myopathy.
Eligibility criteria
Qualifiers
1. At the time of signing the informed consent form, the age is ≥ 18 years old.
2.Based on the 2016 ENMC classification criteria, the clinical diagnosis is IMNM.
3.At the time of screening, the anti-SRP antibody or anti-HMGCR antibody is positive.
4. Refractory IMNM that failed or relapsed after standard treatment, and the disease is still active at the time of screening.
Disqualifiers
1. Having end-stage myositis with involvement of terminal organs may pose additional risks or interfere with the study assessment.
2.Presence of irreversible muscle involvement and/or severe atrophy may bring additional risks or interfere with the study assessment.
3.Uncontrolled interstitial lung disease or any other uncontrolled manifestations of IIM, as judged by the investigator, may require the use of prohibited drugs during the study period.
4. Diagnosed with other inflammatory or non-inflammatory myopathies.
Trial design
Treatments tested in this trial
- Equecabtagene Autoleucel Injection (Eque-cel)
Treatment groups
27 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov