RecruitingEarly Phase 1NCT06663046

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


Sponsor

Wondercel Biotech (ShenZhen)

Enrollment

30 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an off-the-shelf CAR-T cell therapy — engineered immune cells designed to recognize and attack multiple myeloma cancer cells — in patients whose myeloma has come back or stopped responding to prior treatments. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with multiple myeloma (a blood cancer affecting plasma cells) - Your myeloma has relapsed (come back) or is refractory (not responding) to previous treatments - Your disease is still measurable on blood or urine protein tests - Your general health and organ function meet minimum requirements (ECOG score 0-2, expected survival more than 3 months) **You may NOT be eligible if...** - You have not had prior myeloma treatment, or your disease has not yet relapsed or become refractory - You have serious ongoing side effects from prior therapies (above grade 2) - Your blood counts or organ function are below acceptable levels - You have conditions that make you unable to safely undergo this treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSingle 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

DRUGMMF 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.


Locations(1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

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NCT06663046


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