OncoMatch/Clinical Trials/NCT06663046
Universal CAR-T Cells (REVO-UWD-00B) for Refractory and Relapsed Multiple Myeloma
Is NCT06663046 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including Single dose and MMF Immunosuppression for multiple myleoma.
Treatment: Single dose · MMF Immunosuppression — 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.
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: targeted therapy
Exception: within 14 days or 5 half-lives (whichever is shorter)
Prior anti-cancer treatments within 14 days or 5 half-lives (whichever is shorter) including targeted therapy
Cannot have received: epigenetic therapy
Exception: within 14 days or 5 half-lives (whichever is shorter)
Prior anti-cancer treatments within 14 days or 5 half-lives (whichever is shorter) including epigenetic therapy
Cannot have received: investigational drug
Exception: within 14 days or 5 half-lives (whichever is shorter)
Prior anti-cancer treatments within 14 days or 5 half-lives (whichever is shorter) including investigational drugs
Cannot have received: monoclonal antibody therapy
Exception: within 21 days
monoclonal antibody therapy within 21 days
Cannot have received: proteasome inhibitor
Exception: within 14 days
proteasome inhibitor therapy within 14 days
Cannot have received: immunomodulator
Exception: within 7 days
immunomodulators within 7 days
Cannot have received: radiation therapy
Exception: except if the radiotherapy field covers ≤5% of bone marrow
radiotherapy (except if the radiotherapy field covers ≤5% of bone marrow)
Lab requirements
Blood counts
Serum albumin ≥ 25 g/L; Hemoglobin ≥ 8.0 g/dL (without RBC transfusion in the prior 7 days; recombinant human erythropoietin permitted); Absolute neutrophil count ≥ 0.75×10⁹/L (growth factor support allowed if discontinued ≥7 days before test); Platelet count ≥ 60×10⁹/L (no platelet transfusion within 7 days)
Kidney function
Creatinine clearance ≥ 30 mL/min/1.73 m² (using kidney disease formula or 24-hour urine collection)
Liver function
ALT and AST ≤ 3.0×ULN; Total bilirubin ≤ 2.0×ULN (Gilbert's syndrome exception with direct bilirubin ≤ 1.5×ULN)
Cardiac function
No serious cardiac conditions, including but not limited to severe arrhythmias, unstable angina, recent myocardial infarction (within 6 months), NYHA Class III/IV heart failure, recent CABG, unexplained syncope, severe non-ischemic cardiomyopathy, or uncontrolled hypertension.
Laboratory values meeting the following standards, indicating adequate organ and marrow function, with no severe hematological or organ impairment: Serum albumin ≥ 25 g/L Hemoglobin ≥ 8.0 g/dL (without RBC transfusion in the prior 7 days; recombinant human erythropoietin permitted) Absolute neutrophil count ≥ 0.75×10⁹/L (growth factor support allowed if discontinued ≥7 days before test) Platelet count ≥ 60×10⁹/L (no platelet transfusion within 7 days) Creatinine clearance ≥ 30 mL/min/1.73 m² (using kidney disease formula or 24-hour urine collection) ALT and AST ≤ 3.0×ULN Total bilirubin ≤ 2.0×ULN (Gilbert's syndrome exception with direct bilirubin ≤ 1.5×ULN) PT and APTT < 2×ULN Blood oxygen saturation ≥ 95%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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