Antigen-specific T Cell Therapy for AML or MDS Patients With Relapsed Disease After Allo-HCT

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

February 20, 2020

Primary Completion Date

October 31, 2024

Study Completion Date

March 31, 2025

Conditions
Acute Myeloid Leukemia (AML)Myelodysplastic Syndrome (MDS)
Interventions
BIOLOGICAL

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"

Trial Locations (5)

10021

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York

32804

Advent Health Medical Group Blood & Marrow Transplant, Orlando

43210

The James Cancer Hospital and Solove Research Institute OSUCC, Columbus

48201

Karmanos Cancer Institute, Detroit

91010

City of Hope Comprehensive Cancer Center, Duarte

Sponsors

Lead Sponsor

All Listed Sponsors
lead

NexImmune Inc.

INDUSTRY

NCT04284228 - Antigen-specific T Cell Therapy for AML or MDS Patients With Relapsed Disease After Allo-HCT | Biotech Hunter | Biotech Hunter