NCT07510100

Eque-cel for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

A Phase I/II Clinical Study of Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (Equecabtagene Autoleucel) for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (estimated)
• Sponsor: Nanjing IASO Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-armed, open-label, multicenter Phase 1/2 study to evaluate the efficacy and safety of Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (Equecabtagene Autoleucel) in subjects with relapsed and refractory Multiple Myeloma.

Detailed description

This study is divided into two stages: Part 1 and Part 2. Part 1: For exploratory research purposes, no more than 3 subjects will be enrolled at an exploratory dose. Part 2: The purpose of this phase is to explore the efficacy of Equecabtagene Autoleucel (Eque-cel) as a last-line treatment for RRMM and further confirm its safety. In this Study，Leukapheresis procedure will be performed to manufacture Eque-cel modified T cells. Bridging therapy is allowed between PBMC collection and lymphodepletion. Lymphodepletion with fludarabine and cyclophosphamide is performed for three consecutive days. After 1-day rest, subjects will receive a single dose infusion of Eque-cel at 1.0 x 10\^6 CAR+ T cells/Kg or 0.5 x 10\^6 CAR+ T cells/Kg（if all three subjects in Part 1 experience the Toxicity Requiring Dose Reduction）. Subjects will be followed in the study for a minimum of 2 years after Eque-cel infusion.

Conditions

• Relapsed/Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (Eque-cel)	Eque-cel consists of autologous T lymphocytes transduced with anti-BCMA CAR lentiviral vector that contains a unique CAR structure with a fully human single-chain variable fragment (scFv).

Timeline

• Start date: 2026-05-10
• Primary completion: 2029-08-31
• Completion: 2030-01-31
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

3 sites across 1 country: Japan