Large B-Cell Lymphoma (LBCL)NCT07524816
Real World Practice With Academic Anti CD19 CAR-T Cell Therapy in Relapse/Refractory B-cell Lymphoma
An observational study of Large B-Cell Lymphoma (LBCL), run by N.N. Alexandrov National Cancer Centre at 1 site in Belarus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Large B-Cell Lymphoma (LBCL)
- What is being tested?
- CAR-T cell therapy
- How many people
- 76 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Jun 2021to 1 Jan 2029
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with relapse or refractiry LBCL treated in N.N. Alexandron National Cancer Center
Who may be able to join
- age ≥18 years,
- relapsed or refractory LBCL,
- confirmed CD19 expression in tumor tissue,
- prior exposure to at least one line of anti-tumor therapy
Who cannot join
- pregnancy,
- active hepatitis B or C infection, HIV infection,
- naïve T-lymphocyte count (CD3+CCR7+CD45RO-) ≤ 0,5%
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belarus1 site, 1 recruiting
- Recruiting
NN Alexandrov National Cancer Centre of Belarus
Lyasny, Minsk Oblast, 223040
Natalya Konoplya, PhD, MD, Professor, +375447500618, NKonoplya@mail.ru
About this study
Official title: 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.
- Conditions
- Large B-Cell Lymphoma (LBCL)
- Being tested
- CAR-T cell therapy
- Keywords
- academic CAR-T cell products, r/r large B-cell lymphomas, efficacy, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T cell therapyOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
metabolic response evaluated by 2-deoxy-[18F]-fluoro-D-glucose positron emission tomography/computed tomography (FDG-PET/CT) performed on day 30 post-infusion
Measured: day 30 post-infusion
Secondary outcomes (2)
event-free survival (EFS)
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
Measured: 5 years
Overall survival
was calculated from the date of infusion to the date of death or last follow-up.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Jun 2021
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Large B-Cell Lymphoma (LBCL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- N.N. Alexandrov National Cancer Centre
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524816
- Sponsor's protocol ID
- 001-0123
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Katsin M, Dormeshkin D, Meleshko A, Migas A, Dubovik S, Konoplya N. CAR-T Cell Therapy for Classical Hodgkin Lymphoma. Hemasphere. 2023 Nov 16;7(12):e971. doi: 10.1097/HS9.0000000000000971. eCollection 2023 Dec.
PubMed 38026793Konoplya NE, Doroshenko TM, Zharkova KY, Savich TV, Seviaryn IM, Bobrova NM, Beleevsky AA, Sarydze EK, Polyakov SL. Academic anti CD19 CAR-T cell therapy for relapsed/refractory B-cell lymphomas in real-world clinical practice: a prospective cohort study. Front Oncol. 2026 Jul 17;16:1862517. doi: 10.3389/fonc.2026.1862517. eCollection 2026.
PubMed 42539439
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Method of Patients With Refractory and Relapsed CD-19 Positive Leukemia and Lymphoma Using Academic Anti-CD19 CAR-T Human Cells
- ClinicalTrials.gov ID
- NCT07524816
- Acronym / sponsor ID
- 001-0123
- Conditions
- Large B-Cell Lymphoma (LBCL)
- Keywords
- academic CAR-T cell products, r/r large B-cell lymphomas, efficacy, safety
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- N.N. Alexandrov National Cancer CentreOther government
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with relapse or refractiry LBCL treated in N.N. Alexandron National Cancer Center
Key inclusion criteria (4 listed)
- age ≥18 years,
- relapsed or refractory LBCL,
- confirmed CD19 expression in tumor tissue,
- prior exposure to at least one line of anti-tumor therapy
Key exclusion criteria (3 listed)
- pregnancy,
- active hepatitis B or C infection, HIV infection,
- naïve T-lymphocyte count (CD3+CCR7+CD45RO-) ≤ 0,5%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAR-T cell therapyThe 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. | Other | – |
Primary outcome
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
2 secondary outcomes
event-free survival (EFS)
Time frame: 5 years
Overall survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 38026793Katsin M, Dormeshkin D, Meleshko A, Migas A, Dubovik S, Konoplya N. CAR-T Cell Therapy for Classical Hodgkin Lymphoma. Hemasphere. 2023 Nov 16;7(12):e971. doi: 10.1097/HS9.0000000000000971. eCollection 2023 Dec.
- Derived from this study: PubMed 42539439Konoplya NE, Doroshenko TM, Zharkova KY, Savich TV, Seviaryn IM, Bobrova NM, Beleevsky AA, Sarydze EK, Polyakov SL. Academic anti CD19 CAR-T cell therapy for relapsed/refractory B-cell lymphomas in real-world clinical practice: a prospective cohort study. Front Oncol. 2026 Jul 17;16:1862517. doi: 10.3389/fonc.2026.1862517. eCollection 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Large B-Cell Lymphoma (LBCL), run by N.N. Alexandrov National Cancer Centre at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalya Konoplya, PhD, MD, Professor (+375297723101, NKonoplya@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: day 30 post-infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07524816, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.