Academic anti-CD19 CAR-T for relapsed or refractory large B‑cell lymphoma
Official title: Treatment Method of Patients With Refractory and Relapsed CD-19 Positive Leukemia and Lymphoma Using Academic Anti-CD19 CAR-T Human Cells
Run by N.N. Alexandrov National Cancer Centre · NCT07524816 · Data updated 2026-11-12
This project tests whether a locally manufactured anti‑CD19 CAR‑T cell therapy works and is safe for adults whose large B‑cell lymphoma has relapsed or not responded to prior treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 76 (estimated) |
| Sponsor | N.N. Alexandrov National Cancer Centre Government |
| Drugs / interventions | CAR-T, Chimeric antigen receptor |
| Locations | 1 site (Lyasny, Minsk Oblast) |
| Status | Recruiting |
| Started | June 1, 2021 |
| Main results expected | January 1, 2028 |
| Study ends | January 1, 2029 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT07524816 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with relapsed or refractory large B‑cell lymphoma whose tumors express CD19, who have had at least one prior anti‑cancer treatment, and who have adequate naïve T‑cell counts are ideal candidates.
✕Probably not a fit
Patients who are pregnant, have active hepatitis B or C, HIV infection, CD19‑negative tumors, or very low naïve T‑cell counts are unlikely to benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational study of adults with relapsed or refractory large B‑cell lymphoma treated at the N.N. Alexandrov National Cancer Centre in Belarus using an academic anti‑CD19 CAR‑T product manufactured with a lentiviral vector. Participants must have CD19‑positive tumor tissue and prior exposure to at least one line of anti‑tumor therapy, and patients with active hepatitis B/C, HIV, pregnancy, or very low naïve T‑cell counts are excluded. The study will collect real‑world safety and efficacy outcomes after administration of the academic CAR‑T product without randomization. Results will help compare clinical outcomes and tolerability of this locally produced CAR‑T approach to existing commercial therapies.
Why it matters
Potential benefit: If successful, this approach could make CAR‑T therapy more affordable and accessible and potentially produce durable remissions for some patients.
How similar studies have gone: Commercial anti‑CD19 CAR‑T therapies have achieved high remission rates in relapsed/refractory LBCL since 2018, and academic/manufactured CAR‑T programs have reported promising but more limited real‑world results.
Who can join: the full rules
Show full inclusion / exclusion 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%
Where it's running
-
NN Alexandrov National Cancer Centre of Belarus
Lyasny, Minsk Oblast, Belarus Recruiting
Study contacts
- Study coordinator: Natalya Konoplya, PhD, MD, Professor
- Email: NKonoplya@mail.ru
- Phone: +375297723101
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.