Academic anti-CD19 CAR-T for relapsed or refractory large B‑cell lymphoma
Treatment Method of Patients With Refractory and Relapsed CD-19 Positive Leukemia and Lymphoma Using Academic Anti-CD19 CAR-T Human Cells
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 |
|---|---|
| Enrollment | 76 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | N.N. Alexandrov National Cancer Centre Government |
| Drugs / interventions | CAR-T, Chimeric antigen receptor |
| Locations | 1 site (Lyasny, Minsk Oblast) |
| Trial ID | NCT07524816 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lyasny, Minsk Oblast
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.