Efficacy and safety of the academic anti‐CD19 chimeric antigen receptor T‐cell product varnimcabtagene autoleucel for the treatment of relapsed/refractory follicular lymphoma
We report the outcome of patients with relapsed/refractory (R/R) follicular lymphoma (FL) treated with varnimcabtagene autoleucel (var-cel), an academic anti-CD19 chimeric antigen receptor (CAR) T-cell product. Patients were included in the CART19-BE-01 clinical trial and a compassionate use program. Twenty-seven patients with FL were treated. Cytokine release syndrome (any grade) occurred in 55% of patients (4% Grade ≥3). Only 1 case (4%) of Grade 1 neurotoxicity was documented. The objective response rate was 100% at Day +100 (93% complete response rate), and the 3-year duration of response was 78%. The 3-year progression-free survival and overall survival were 78% and 81%, respectively. All patients developed B-cell aplasia, and the 3-year incidence of B-cell recovery was 17%. In conclusion, patients with R/R FL treated with var-cel obtained excellent disease control, with prolonged CAR T-cell survival and manageable toxicity. This trial was registered as NCT03144583.
Authors
- Miquel Lozano (ORCID: https://orcid.org/0000-0003-2593-833X)
- Eulàlia Olesti (ORCID: https://orcid.org/0000-0001-8677-9964)
- Andrea Rivero (ORCID: https://orcid.org/0000-0002-4233-5031)
- Nil Albiol (ORCID: https://orcid.org/0000-0003-2942-1362)
- Sara Varea (ORCID: https://orcid.org/0000-0002-0002-6492)
- Armando López‐Guillermo
- Carla Sans‐Pola (ORCID: https://orcid.org/0000-0002-5834-3183)
- Julio Delgado (ORCID: https://orcid.org/0000-0002-5157-4376)
- Juan José Mata (ORCID: https://orcid.org/0000-0001-8827-5073)
- Carlos Jiménez‐Vicente (ORCID: https://orcid.org/0000-0002-9548-4305)
- Marta Español‐Rego (ORCID: https://orcid.org/0000-0001-5497-2276)
- Xavier Setoaín
- Carlos Fernández de Larrea (ORCID: https://orcid.org/0000-0003-4930-9255)
- Juan Gonzalo Correa (ORCID: https://orcid.org/0000-0001-6470-8102)
- Pau Alcubilla (ORCID: https://orcid.org/0000-0003-3145-4518)
- Katerin Rojas (ORCID: https://orcid.org/0009-0003-4261-8597)
- Valentín Ortiz‐Maldonado (ORCID: https://orcid.org/0000-0003-4699-6862)
- Joaquín Sáez‐Peñataro (ORCID: https://orcid.org/0000-0002-8370-4761)
- Carla Ramos
- Sónia Rodríguez (ORCID: https://orcid.org/0000-0002-1257-2757)
- Eva Giné (ORCID: https://orcid.org/0000-0002-0532-1204)
- Hugo Calderón (ORCID: https://orcid.org/0000-0002-8902-4302)
- Pablo Mozas (ORCID: https://orcid.org/0000-0001-9528-4971)
- Mercedes Montoro‐Lorite
- Sergio Navarro‐Velázquez (ORCID: https://orcid.org/0000-0002-5565-4218)
- Europa Azucena González‐Navarro (ORCID: https://orcid.org/0000-0003-3310-5557)
- Paola Charry (ORCID: https://orcid.org/0000-0002-4777-9643)
- Manel Juan (ORCID: https://orcid.org/0000-0002-3064-1648)
- Letícia Alserawan (ORCID: https://orcid.org/0000-0003-0428-9844)
- María Sánchez‐Castañón (ORCID: https://orcid.org/0009-0006-0740-1837)
- Laura Magnano (ORCID: https://orcid.org/0000-0002-6928-8386)
- Núria Martínez‐Cibrián (ORCID: https://orcid.org/0000-0002-8688-1202)
- Adrià Murias
- Daniel Benítez‐Ribas (ORCID: https://orcid.org/0000-0002-2346-5324)
- Mireia Bachiller (ORCID: https://orcid.org/0000-0002-6153-4722)
- Albert Cortés‐Bullich (ORCID: https://orcid.org/0000-0002-6260-901X)
- María Calvo‐Orteu (ORCID: https://orcid.org/0000-0002-4746-6823)
- Pilar Ayora
Institutions
- Biomedical Research Networking Center in Bioengineering, Biomaterials and Nanomedicine (ES)
- Hospital Clínic de Barcelona (ES)
- Fundació Clínic per a la Recerca Biomèdica (ES)
- Centro de Investigación Biomédica en Red de Cáncer (ES)
- Consorci Institut D'Investigacions Biomediques August Pi I Sunyer (ES)
- Universitat de Barcelona (ES)
Publication Details
- Journal
- HemaSphere
- Published
- 2025-09-01
- DOI
- https://doi.org/10.1002/hem3.70166
- Citations
- 1
- Primary Topic
- CAR-T cell therapy research
- Type
- article
- Field-Weighted Citation Impact
- 1.05
Funders
- Universitat de Barcelona