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NCT Number: NCT07524816

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

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.

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Key information

Conditions

Large B-Cell Lymphoma (LBCL)

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NN Alexandrov National Cancer Centre of Belarus

Lyasny, Minsk Oblast, 223040, Belarus

Location status: Recruiting

Location contact

Natalya Konoplya, PhD, MD, Professor

CONTACT

[email protected]

+375447500618

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

CAR-T Cell Therapy

Other

The academic CAR-T cell product presented in this study encodes the anti-CD19 CAR construct with the single-chain variable fragment (scFv) of an anti-CD19 monoclonal antibody (FMC63) conjugated with the CD8 hinge region, CD4-1BB transmembrane (TM), co-stimulatory domain, and the CD3ζ pro-activator signaling domain along with a truncated form of the epidermal growth factor receptor (EGFRt) cell surface protein as a co-expression marker and a safety switch mechanism.

Primary outcomes

  1. ORR

    Time frame: day 30 post-infusion

    metabolic response evaluated by 2-deoxy-[18F]-fluoro-D-glucose positron emission tomography/computed tomography (FDG-PET/CT) performed on day 30 post-infusion

Secondary outcomes

  1. event-free survival (EFS)

    Time frame: 5 years

    was defined as the time from CAR T-cell infusion to disease progression, relapse, or death from any cause, whichever occurred first; patients alive without events were censored at the last follow-up

  2. Overall survival

    Time frame: 5 years

    was calculated from the date of infusion to the date of death or last follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Natalya Konoplya, PhD, MD, Professor

CONTACT

[email protected]

+375297723101

Sponsors and collaborators

Lead sponsor

N.N. Alexandrov National Cancer Centre

Other Gov

Registry information

Official study title

Treatment Method of Patients With Refractory and Relapsed CD-19 Positive Leukemia and Lymphoma Using Academic Anti-CD19 CAR-T Human Cells

Important dates

Study start
2021
Primary completion
2028
Study completion
2029
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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