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

April 9, 2026 updated by: N.N. Alexandrov National Cancer Centre

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Natalya Konoplya, PhD, MD, Professor
  • Phone Number: +375297723101
  • Email: NKonoplya@mail.ru

Study Locations

  • Belarus
    • Minsk Oblast
      • Lyasny, Minsk Oblast, Belarus, 223040
        • Recruiting
        • NN Alexandrov National Cancer Centre of Belarus
        • Contact:
          • Natalya Konoplya, PhD, MD, Professor
          • Phone Number: +375447500618
          • Email: NKonoplya@mail.ru

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with relapse or refractiry LBCL treated in N.N. Alexandron National Cancer Center

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 30 post-infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years
Overall survival
Time Frame: 5 years
was calculated from the date of infusion to the date of death or last follow-up.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

N.N. Alexandrov National Cancer Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001-0123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Large B-Cell Lymphoma (LBCL)

Clinical Trials on CAR-T cell therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe