RecruitingEarly Phase 1NCT06662227

Universal CAR-T Cells (REVO-UWD-19) for Refractory and Relapsed B-Cell Tumors

A Clinical Study Evaluating the Safety and Efficacy of Universal CD19-Targeted CAR-T (UWD-CD19) Therapy for Refractory and Relapsed B-Cell Tumors


Sponsor

Wondercel Biotech (ShenZhen)

Enrollment

30 participants

Start Date

Oct 24, 2024

Study Type

INTERVENTIONAL

Summary

This study is a single-arm, single-center, investigator-initiated clinical trial. The primary objective is to evaluate the safety and preliminary efficacy of administering universal CD19 CAR-T cells to subjects with refractory and relapsed B-cell tumors. Eligible participants will undergo FC lymphodepleting chemotherapy preconditioning after signing an informed consent form, followed by a one-time injection of universal UWD-19 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: 3 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune cell therapy called "universal CAR-T" cells — specially engineered immune cells designed to recognize and attack a protein (CD19) found on B-cell lymphoma tumors. Unlike standard CAR-T therapy made from each patient's own cells, this version uses donor-derived cells that can be used off-the-shelf. **You may be eligible if...** - You are between 3 and 70 years old - You have been diagnosed with B-cell lymphoma with CD19-positive tumors - Your lymphoma has come back or stopped responding to at least 2 lines of standard treatment - You have at least one measurable tumor visible on scans **You may NOT be eligible if...** - Your lymphoma has not progressed or relapsed as defined by standard criteria - You had a relapse more than 12 months after a stem cell transplant (specific timing rules apply) - Your disease does not have a measurable lesion on imaging - You have other serious medical conditions that would make participation unsafe 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-19

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-19 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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NCT06662227