RecruitingNot Applicable

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

Belarus76 participantsStarted 2021-06-01

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age ≥18 years, * relapsed or refractory LBCL, * confirmed CD19 expression in tumor tissue, * prior exposure to at least one line of anti-tumor therapy Exclusion Criteria: * pregnancy, * active hepatitis B or C infection, HIV infection, * naïve T-lymphocyte count (CD3+CCR7+CD45RO-) ≤ 0,5%

What they're measuring

ORR

Timeframe: day 30 post-infusion

Trial details

NCT IDNCT07524816

SponsorN.N. Alexandrov National Cancer Centre

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2028-01-01

Contact for this trial

Natalya Konoplya, PhD, MD, Professor

+375297723101 NKonoplya@mail.ru

View on ClinicalTrials.gov More Large B-Cell Lymphoma (LBCL) trials