Ph I/II Study of E7777 Prior to CAR-T for R/R LBCL

Phase 1/2 Suspended 30 enrolled Masonic Cancer Center, University of Minnesota

Non-randomizedSequentialOpen-labelTreatment

Summary

This is a multicenter Phase I study to determine the maximum tolerated dose (MTD) of E7777 when given prior to cyclophosphamide/fludarabine (CY/Flu) lymphodepletion (LD) chemotherapy and an FDAapproved CAR-T product Tisagenlecleucel/Kymriah, Axicabtagene Ciloleucel/Yescarta, or lisocabtagene maraleucel/Breyanzi) for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma grade 3 who are at a higher risk for failure of CAR-T therapy

Timeline

Start: 2021-06-09
Primary completion: 2026-09
Completion: 2026-12

Publications

Mahdi HS, Woodall-Jappe M, Singh P, Czuczman MS. Targeting regulatory T cells by E7777 enhances CD8 T-cell-mediated anti-tumor activity and extends survival benefit of anti-PD-1 in solid tumor models. Front Immunol. 2023 Oct 27;14:1268979. doi: 10.3389/fimmu.2023.1268979. eCollection 2023.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	denileukin diftitox	Protein / enzyme biologic	5 ug/kg	—
Subject	denileukin diftitox	Protein / enzyme biologic	7 ug/kg	—
Subject	denileukin diftitox	Protein / enzyme biologic	9 ug/kg	—
Background	Axicabtagene Ciloleucel	Cell therapy	—	—
Background	Cyclophosphamide	Other / unclassified	250 mg/m2	Intravenous
Background	Fludarabine	Small molecule	25 mg/m2	Intravenous
Background	Lisocabtagene Maraleucel	Cell therapy	—	—
Background	Tisagenlecleucel	Cell therapy	—	—

Ph I/II Study of E7777 Prior to CAR-T for R/R LBCL

Summary

Timeline

Publications

Drugs

Indications