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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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
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.
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
RECRUITINGMaximum Tolerated Dose (MTD)
The highest dose of UWD-19 CAR-T cells that can be administered without causing unacceptable side effects, measured during the dose escalation phase.
Time frame: Within the first month post-infusion.
Dose-Limiting Toxicities (DLT)
The incidence of treatment-related toxicities that prevent further dose escalation.
Time frame: Within the first month post-infusion.
Treatment-Emergent Adverse Events (TEAE)
The frequency and severity of adverse events that arise following the administration of UWD-00B CAR-T cells.
Time frame: From the administration of UWD-00B CAR-T cells through six months post-infusion
Objective Response Rate (ORR)
The proportion of patients with a measurable efficacy (complete or partial response) following UWD-00B CAR-T therapy.
Time frame: Measured at 3 and 6 months after treatment
Progression-Free Survival (PFS)
The length of time during and after treatment that the patient lives without disease progression.
Time frame: From the start of treatment up to 5 years
Overall Survival (OS)
The duration from the start of treatment to the time of death from any cause.
Time frame: From the start of treatment up to maximum follow-up period of five years
Duration of Response (DOR)
The time from initial response (CR or PR) to disease progression or relapse or any cause of death.
Time frame: From the administration of UWD-00B CAR-T cells to a maximum follow-up period of five years
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