Real World Practice With Academic Anti CD19 CAR-T Cell Therapy in Relapse/Refractory B-cell Lymphoma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorN.N. Alexandrov National Cancer Centre

About this trial

Chimeric antigen receptor (CAR) T-cell therapy has been the standard of care for relapsed/refractory large B-cell lymphomas (R/R LBCLs) since 2018. However, high cost of commercial products limits their application in real-world clinical practice. Academic approach to manufacturing CAR-T cell products can reduce the costs and improve availability and affordability of this therapy option. The aim of the present study is assess the efficacy and safety of the use of academic CAR-T cell products in r/r LBCL patients.This prospective observational study with r/r LBCL patients treated in the NN Alexandrov National Cancer Centre of Belarus. The CAR-T cell product was manufactured using lentiviral vector encoding anti-CD19 CAR.

Eligibility criteria

Qualifiers

age ≥18 years,

relapsed or refractory LBCL,

confirmed CD19 expression in tumor tissue,

prior exposure to at least one line of anti-tumor therapy

Disqualifiers

pregnancy,

active hepatitis B or C infection, HIV infection,

naïve T-lymphocyte count (CD3+CCR7+CD45RO-) ≤ 0,5%

Trial design

Treatments tested in this trial

  • CAR-T cell therapy

Treatment groups

No treatment groups listed