drugset / Trial / NCT04186520
CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a Phase I/II, interventional, single-arm, open-label, treatment study designed to evaluate the safety and efficacy of Interleukin-7 and Interleukin-15 (IL-7/IL-15) manufactured chimeric antigen receptor (CAR)-20/19-T cells as well as the feasibility of a flexible manufacturing schema in adult patients with B cell malignancies that have failed prior therapies.
Timeline
- Start
- 2020-05-18
- Primary completion
- 2027-02-28
- Completion
- 2029-02-28
Publications
- Shah V, Womack JA, Palen K, Johnson BD, Hematti P, Kearl TJ, Shah NN, Terhune SS, Dash RK. Data-driven computational modeling of CAR-T cell function. Front Immunol. 2026 May 13;17:1707783. doi: 10.3389/fimmu.2026.1707783. eCollection 2026.
- Shah NN, Colina AS, Johnson BD, Szabo A, Furqan F, Kearl T, Schneider D, Vargas-Cortes M, Schmeling JL, Dwinell MB, Palen K, Longo W, Hematti P, Zamora AE, Hari P, Bucklan D, Cunningham A, Hamadani M, Fenske TS. Phase I/II Study of Adaptive Manufactured Lentiviral Anti-CD20/Anti-CD19 Chimeric Antigen Receptor T Cells for Relapsed, Refractory Mantle Cell Lymphoma. J Clin Oncol. 2025 Jul 10;43(20):2285-2295. doi: 10.1200/JCO-24-02158. Epub 2025 Mar 31.
- Zurko JC, Xu H, Chaney K, Schneider D, Szabo A, Hari P, Johnson BD, Shah NN. Bispecific targeting of CD20 and CD19 increases polyfunctionality of chimeric antigen receptor T-cell products in B-cell malignancies. Cytotherapy. 2022 Aug;24(8):767-773. doi: 10.1016/j.jcyt.2022.03.011. Epub 2022 May 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LV20.19 CAR T cells | Cell therapy | 2.5e+06 cells/kg | — |