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

NCT07524816 | Recruiting

• 1 other identifier: 001-0123
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Large B-Cell Lymphoma (LBCL)

Keywords

academic CAR-T cell products; r/r large B-cell lymphomas; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• 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

  day 30 post-infusion

Secondary Outcomes (2)

• event-free survival (EFS)

  5 years

• Overall survival

  5 years

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• age ≥18 years,
• relapsed or refractory LBCL,
• confirmed CD19 expression in tumor tissue,
• prior exposure to at least one line of anti-tumor therapy

You may not qualify if:

• pregnancy,
• active hepatitis B or C infection, HIV infection,
• naïve T-lymphocyte count (CD3+CCR7+CD45RO-) ≤ 0,5%

Sponsors & Collaborators

• N.N. Alexandrov National Cancer Centre: lead

Study Sites (1)

NN Alexandrov National Cancer Centre of Belarus

Lyasny, Minsk Oblast, 223040, Belarus

RECRUITING

Related Publications (1)

• 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.

  PMID: 38026793 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

Immunotherapy, Adoptive

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Central Study Contacts

Natalya Konoplya, PhD, MD, Professor

CONTACT

+375297723101; NKonoplya@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 13, 2026
• Study Start: June 1, 2021
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

BE (1)