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OncoMatch/Clinical Trials/NCT06662227

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

Is NCT06662227 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including Single dose and MMF Immunosuppression for b cell lymphoma.

Early Phase 1RecruitingWondercel Biotech (ShenZhen)NCT06662227Data as of May 2026

Treatment: Single dose · MMF ImmunosuppressionThis 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.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Biomarker criteria

Required: CD19 positivity

CD19 positivity confirmed by flow cytometry or immunohistochemistry

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 2 prior lines

Must have received: second-line or higher treatment

Received ≥2 cycles of standardized second-line or higher treatment, and meets Lugano 2014 criteria for best clinical response: Progressive Disease (PD) on the most recent treatment. Stable Disease (SD) lasting <6 months before progressing.

Must have received: autologous stem cell transplant

Recurrence or progression ≤12 months post-autologous stem cell transplant

Cannot have received: targeted, epigenetic, or experimental drug therapy

Targeted, epigenetic, or experimental drug therapy within 14 days or 5 half-lives

Cannot have received: cytotoxic therapy

Cytotoxic therapy within 14 days

Cannot have received: immunomodulator

Immunomodulators within 7 days

Cannot have received: monoclonal antibody

Monoclonal antibodies within 21 days

Cannot have received: radiotherapy

Radiotherapy within 14 days

Lab requirements

Blood counts

Serum albumin ≥25 g/L; Oxygen saturation ≥95%; Blood transfusions allowed to maintain hemoglobin ≥8.0 g/dL; PT and APTT <2× ULN

Kidney function

Creatinine clearance ≥30 mL/min/1.73 m²

Liver function

ALT and AST ≤3.0× ULN; Total bilirubin ≤2.0× ULN (exceptions for congenital hyperbilirubinemia like Gilbert syndrome with direct bilirubin ≤1.5× ULN)

Cardiac function

No severe cardiac dysfunction (e.g., arrhythmias, unstable angina, recent MI, heart failure NYHA III/IV, uncontrolled hypertension)

Laboratory values indicating adequate organ and marrow function, with no severe cardiac, pulmonary, hepatic, renal, or immune dysfunction

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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