22
Participants
Start Date
February 20, 2020
Primary Completion Date
October 31, 2024
Study Completion Date
March 31, 2025
Infusion of NEXI-001 T Cells
"Procedure: A single IV infusion of NEXI-001 T Cells at Day 1 after Lymphodepletion(LD) Therapy.~At dose Level 1: 1.0 x 108 total viable T cells At dose Level 2: 2.0 x 108 total viable T cells~Procedure: Lymphodepletion: IV administration of fludarabine 30 mg/2 and cyclophosphamide 300 mg/m2 for 3 days.~lymphodepletion (LD) Therapy: Subjects will received bridging therapy agents during lymphodepletion for 3 consecutive days prior to receiving the NEXI-001 product~Drug: Fludarabine~Fludarabine infusion~Other Name: Fludarabine monophosphate~Drug: Cyclophosphamide~Cyclophosphamide infusion~Other Name: Cytoxan"
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York
Advent Health Medical Group Blood & Marrow Transplant, Orlando
The James Cancer Hospital and Solove Research Institute OSUCC, Columbus
Karmanos Cancer Institute, Detroit
City of Hope Comprehensive Cancer Center, Duarte
Lead Sponsor
NexImmune Inc.
INDUSTRY