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NOT YET RECRUITING
NCT07752264
PHASE1/PHASE2

A Phase I/II Study of Eque-cel in Subjects Withimmune-mediated Necrotizing Myopathy

Sponsor: Nanjing IASO Biotechnology Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: An Open-label, Single-arm Phase I/II Clinical Study to Evaluate the Safety and Efficacy of Equecabtagene Autoleucel Injection (Eque-cel) in Subjects With Immune-mediated Necrotizing Myopathy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

27

Start Date

2026-08-15

Completion Date

2043-08-15

Last Updated

2026-08-07

Healthy Volunteers

No

Interventions

DRUG

Equecabtagene Autoleucel Injection (Eque-cel)

Eque-cel is a personalized, BCMA-targeted gene-modified autologous T-cell immunotherapy product capable of recognizing and eliminating both malignant and normal cells expressing BCMA. The CAR specifically identifies BCMA via a fully human single-chain variable fragment (scFv) with low immunogenicity, activates, proliferates, secretes cytokines, and kills target cells through the CD3ζ domain, while enhancing CAR-T expansion and persistence via 4-1BB costimulation signaling. Eque-cel demonstrates high affinity for the BCMA antigen both in vitro and in vivo, as well as efficient killing of antigen-loaded cells.

Locations (4)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Huashan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China