NCT07524816 Real World Practice With Academic Anti CD19 CAR-T Cell Therapy in Relapse/Refractory B-cell Lymphoma
| NCT ID | NCT07524816 |
| Status | Recruiting |
| Phase | — |
| Sponsor | N.N. Alexandrov National Cancer Centre |
| Condition | Large B-Cell Lymphoma (LBCL) |
| Study Type | OBSERVATIONAL |
| Enrollment | 76 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 76 participants in total. It began in 2021-06-01 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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%
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07524816 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Large B-Cell Lymphoma (LBCL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07524816 currently recruiting?
Yes, NCT07524816 is actively recruiting participants. Contact the research team at NKonoplya@mail.ru for enrollment information.
Where is the NCT07524816 trial being conducted?
This trial is being conducted at Lyasny, Belarus.
Who is sponsoring the NCT07524816 clinical trial?
NCT07524816 is sponsored by N.N. Alexandrov National Cancer Centre. The trial plans to enroll 76 participants.