NCT06663046

Universal CAR-T Cells (REVO-UWD-00B) for Refractory and Relapsed Multiple Myeloma

A Clinical Study Evaluating the Safety and Efficacy of Universal BCMA-Targeted CAR-T (UWD-00B) Therapy for Refractory and Relapsed Multiple Myeloma

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Wondercel Biotech (ShenZhen) · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, investigator-initiated clinical trial. The primary objective is to evaluate the safety and preliminary efficacy of administering universal BCMA CAR-T cells to subjects with refractory and relapsed multiple myeloma. Eligible participants will undergo FC preconditioning after signing an informed consent form, followed by a one-time injection of universal UWD-00B cells to assess its safety and efficacy. Subjects will be hospitalized for a period, and after discharge, they will undergo periodic efficacy assessments and long-term survival follow-up for at least five years.

Detailed description

Multiple myeloma is a malignant plasma cell disease with high mortality rates. Patients with relapsed and refractory cases, especially those resistant to conventional therapies (immunomodulators, proteasome inhibitors, and anti-CD38 monoclonal antibodies), typically have limited survival. CAR-T cell therapy is a cutting-edge approach in which T cells are genetically modified to target cancer cells. UWD-00B is designed to target BCMA, a protein highly expressed on myeloma cells but minimally present in other body tissues, making it an ideal target. Previous BCMA CAR-T therapies have shown promise, but production limitations make universal, off-the-shelf products like UWD-00B critical for broader patient accessibility. Primary Objective is to evaluate the safety and initial efficacy of UWD-00B in patients with r/r MM. The secondary Objectives is to investigate pharmacokinetic (PK) and pharmacodynamic (PD) characteristics, including the persistence and effectiveness of UWD-00B in targeting BCMA-positive cells. This study will enroll approximately 30 patients with relapsed or refractory MM, aged 18-75. Following preconditioning chemotherapy to enhance CAR-T cell efficacy, patients will receive a single infusion of UWD-00B. The study spans multiple phases, including screening, infusion, and a two-year follow-up to assess both short- and long-term safety and efficacy. This study hopes to provide data supporting UWD-00B as an effective, accessible treatment for r/r MM, potentially paving the way for similar universal CAR-T therapies in other cancers.

Conditions

• Multiple Myleoma
• Refractory and Relapsed Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	Single dose injection of certain dose of UWD-00B	Eligible participants will undergo FC lymphodepleting chemotherapy preconditioning after signing an informed consent form, followed by a one-time injection of certain dose of universal UWD-00B cells
DRUG	MMF Immunosuppression	One day after the completion of fludarabine preconditioning (D-2), initiate oral mycophenolate sodium at a dose of 1440 mg twice daily (BID) for 15 consecutive days, or extend the duration appropriately based on CAR-T cell expansion status (discontinuation may occur at the end of CAR-T cell expansion or on the day of patient discharge). The maximum duration of administration must not exceed 30 days.

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-12-30
• Completion: 2029-12-30
• First posted: 2024-10-29
• Last updated: 2026-01-20

Locations

1 site across 1 country: China