Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of r/r B-NHL Clinical Research

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age19-70
SponsorZhejiang University

About this trial

A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Non-Hodgkin lymphoma

Eligibility criteria

Qualifiers

All subjects or guardians must sign an informed consent form approved by the Ethics Committee in person before commencing any screening process;

Age > 18 years old, ≤ 70 years old, male or female;

Diagnosis of relapsed/refractory (R/R) indolent B-cell lymphoma, and/or R/R diffuse large B-cell lymphoma (DLBCL). Refractory diseases are defined as one of the following:

Patients with relapsed or refractory B-cell lymphoma treated with one standard treatment regimen and one salvage regimen treated with rituximab or another CD20 antibody drug and at least two treatment regiments appropriate for their disease, one of which should include anthracyclines;

Disqualifiers

Patients with present or history of central nervous system diseases not associated with leukemia or lymphoma, such as seizures disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement;

Patients who had received chemotherapy other than preconditioning chemotherapy within 2 weeks prior to Meta10-19 infusion;

Patients who participated in other clinical trials within 30 days prior to enrollment;

Patients with active hepatitis B (defined as hepatitis B surface antigen positive or hepatitis B core antibody positive, concomitant hepatitis B virus DNA level > 1000 copies/ml) or hepatitis C (HCV RNA positive);

Trial design

Treatments tested in this trial

  • Metabolically Armed CD19 CAR-T cells

Treatment groups

36 Participants
are divided into 1 treatment group

Sponsors and collaborators

Zhejiang University

Lead sponsor

Leman Biotech Co., Ltd.

Collaborator