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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 9, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
DLBCLDiffuse Large B Cell LymphomaHigh-grade B-cell LymphomaDLBCL Arising From Follicular Lymphoma
Interventions
DRUG

E7777

E7777 is a recombinant fusion toxin consisting of full-length human IL-2 fused to the catalytic domains of diphtheria toxin. E7777 is preferentially bound to and internalized by cells expressing the high affinity form (CD25+) of the IL-2 receptor.

DRUG

Fludarabine

Fludarabine 25 mg/m2 IV daily for 3 days. Days -5, -4 and -3. Taken in combination with Cyclophosphamide

DRUG

Cyclophosphamide

Cyclophosphamide 250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine. Days -5, -4 and -3.

DRUG

Tisagenlecleucel

Patient will receive one FDA approved CAR-T product - Tisagenlecleucel/Kymriah, Axicabtagene Ciloleucel/Yescarta, or lisocabtagene maraleucel/Breyanzi) for the treatment of relapsed/refractory diffuse large B-cell lymphoma

DRUG

Axicabtagene Ciloleucel

Patient will receive one FDA approved CAR-T product - Tisagenlecleucel/Kymriah, Axicabtagene Ciloleucel/Yescarta, or lisocabtagene maraleucel/Breyanzi) for the treatment of relapsed/refractory diffuse large B-cell lymphoma

DRUG

Lisocabtagene Maraleucel Intravenous Suspension

Patient will receive one FDA approved CAR-T product - Tisagenlecleucel/Kymriah, Axicabtagene Ciloleucel/Yescarta, or lisocabtagene maraleucel/Breyanzi) for the treatment of relapsed/refractory diffuse large B-cell lymphoma

Trial Locations (1)

55455

RECRUITING

University of Minnesota, Masonic Cancer Center, Minneapolis

All Listed Sponsors
lead

Masonic Cancer Center, University of Minnesota

OTHER