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NCT05651100
Safety and Efficacy of Sequential CD19 and CD22 Targeted CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma
Conditions: Lymphoma, B-Cell
Sex: All
Ages: 3 Years – 70 Years
Phase: PHASE1, PHASE2
Enrollment: 50
Sponsor: Kecellitics Biotech Company Ltd
Location: China
Summary
This is a single arm study to evaluate the efficacy and safety of Sequential CD19 and CD22 targeted CAR-T cells therapy for patients with relapsed/refractory B Cell Lymphoma.
Eligibility Criteria
Inclusion Criteria:Relapsed or refractory B cell non-hodgkin lymphoma.KPS>60.Life expectancy>12 weeks.Gender unlimited, age from 3 years to 70 years.Evidence for cell membrane CD19 and/or CD22 expression;Patients who have failed at least one line of a standard treatment.No serious mental disorder.Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).No other serious diseases(autoimmune disease, immunodeficiency etc.).No other tumors.Patients volunteer to participate in the research.Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trialExclusion Criteria:Pregnancy and nursing females.Patients are allergic to cytokines.Uncontrolled active infection.Acute or chronic GVHD.Treated with T cell inhibitor.Patients who had used steroid hormones within one week.Patients who had used Rituximab within two weeks.HIV/HBV/HCV Infection.Other situations we think improper for the research.
Source: ClinicalTrials.gov (NCT05651100). StuddyBuddy aggregates publicly available trial information.