Study of CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell

Summary

This is a phase 1/1b, interventional single arm, open label, treatment study designed to evaluate the safety and feasibility of infusion of autologous T cells engineered to contain an anti-cluster of differentiation 19 (CD19) and anti-cluster of differentiation 20 (CD20) single chain variable fragment (scFv) coupled to cluster of differentiation CD3ζ (CD3ζ) and co-stimulatory domain 4-1BB (4-1BB) signaling domains in patients with relapsed and/or refractory CD19 or CD20 positive B cell malignancies

Timeline

Start

2017-10-16

Primary completion

2019-10-01

Completion

2021-08-24

Publications

• Zurko JC, Fenske TS, Johnson BD, Bucklan D, Szabo A, Xu H, Chaney K, Hamadani M, Hari P, Shah NN. Long-term outcomes and predictors of early response, late relapse, and survival for patients treated with bispecific LV20.19 CAR T-cells. Am J Hematol. 2022 Dec;97(12):1580-1588. doi: 10.1002/ajh.26718. Epub 2022 Sep 20.
• Knight JM, Szabo A, Arapi I, Wu R, Emmrich A, Hackett E, Sauber G, Yim S, Johnson B, Hari P, Schneider D, Dropulic B, Cusatis RN, Cole SW, Hillard CJ, Shah NN. Patient-reported outcomes and neurotoxicity markers in patients treated with bispecific LV20.19 CAR T cell therapy. Commun Med (Lond). 2022 May 12;2(1):49. doi: 10.1038/s43856-022-00116-5. eCollection 2022.
• Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
• Shah NN, Johnson BD, Schneider D, Zhu F, Szabo A, Keever-Taylor CA, Krueger W, Worden AA, Kadan MJ, Yim S, Cunningham A, Hamadani M, Fenske TS, Dropulic B, Orentas R, Hari P. Bispecific anti-CD20, anti-CD19 CAR T cells for relapsed B cell malignancies: a phase 1 dose escalation and expansion trial. Nat Med. 2020 Oct;26(10):1569-1575. doi: 10.1038/s41591-020-1081-3. Epub 2020 Oct 5.

Drugs

Indications