Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 years |
| Overall survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
patients with relapse or refractiry LBCL treated in N.N. Alexandron National Cancer Center
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natalya Konoplya, PhD, MD, Professor | Contact | +375297723101 | NKonoplya@mail.ru |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NN Alexandrov National Cancer Centre of Belarus | Recruiting | Lyasny | Minsk Oblast | 223040 | Belarus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38026793 | Background | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 9, 2024 | Apr 9, 2026 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D016219 | Immunotherapy, Adoptive |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
Not provided
Not provided
Not provided
Not provided
Not provided
was calculated from the date of infusion to the date of death or last follow-up. |
| 5 years |
| D056747 |
| Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |