This Phase 1/2 study examines sequential CAR-T cell therapy targeting CD5 and CD7 (EB-BH2026) in patients with relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL) or ETP-ALL. The primary aim is to assess safety, including cytokine storm and other adverse effects; disease status after treatment will also be evaluated. Participants must have failed to achieve complete remission after induction therapy or have relapsed after remission.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Signed written informed consent; Patients volunteer to participate in the clinical trial; * Diagnosis is mainly based on the World Health Organization (WHO) 2008; * Complete remission cannot be achieved after induction therapy; recurrence occurs after completion remission; the burden of leukemic blasts in the peripheral blood or bone marrow is greater than 5%; * Leukemic blast cells express CD7/CD5 (CD7 OR CD5 positive by flow cytometry or immunohistochemistry ≥70%); * The expected survival period is greater than 12 weeks; * ECOG score ≤2; * Age 2-60 years old; * HGB≥70g/L (can be transfused); * Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value. Exclusion Criteria: * Patients declining to consent for treatment * Prior solid organ transplantation * One of the following cardiac issues: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT syndrome or secondary QT prolongation; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV; * History of severe pulmonary dysfunction diseases; * Severe infection or persistent infection cannot be effectively controlled; * Severe autoimmune disease or congenital immunodeficiency; * Active hepatitis; * Human immunodeficiency virus (HIV) infection; * Clinically significant viral infections, or uncontrollable viral reactivation, including EBV (Epstein-Barr virus).