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NCT04505813: Phase 1- Antigen-specific T Cell Therapy NEXI 002 Relapsed Refractory Multiple Myeloma

Updated: Aug 9

NCT04505813: Phase 1- Antigen-specific T Cell Therapy for Patients With Relapsed Refractory Multiple Myeloma


This Research study is being done to characterize the safety, tolerability, and preliminary antitumor activity of the NEXI-002 T cell product (a new experimental therapy), which contains populations of CD8+ T cells targeting multiple Myeloma associated antigen peptides in patients with relapsed refractory multiple myeloma (MM).

The study will enroll patients with MM who have relapsed or are refractory to standard lines of treatment. The enrolled patients will undergo bridging therapy for the purposes of disease control while the NEXI-002 T cell product is being manufactured. Choice of bridging therapy administered will be per the Investigator's discretion, but is limited to acceptable agents as specified in the protocol. Bridging therapy will be administered prior to lymphodepleting (LD) therapy, with the last dose of the bridging therapy administered ≥ 14 days prior to initiation of LD therapy. Within 72 hours after completing LD therapy, patients will receive a single IV infusion of the NEXI-002 T cell product.


NexImmune Inc.


ClinicalTrials.gov Identifier: NCT04505813

A Phase 1 / 2 Study to Evaluate the Safety and Tolerability of Adoptively Transferred Autologous T Cells in Patients With Relapsed Refractory Multiple Myeloma

First Posted : August 10, 2020

Click here for details on ClinicalTrials.gov


Biological: NEXI-002 T Cells

multi-antigen-directed autologous T cells NEXI-002

autologous MM-associated antigens specific T cells NEXI-002

NEXI-002 T cells

TAA primed antigen-specific CD8+ T cells NEXI-002

NEXI 002


704.Cellular Immunotherapies: Clinical| November 5, 2021

Phase 1/2 Study of Nexi-002 Autologous Multi-Antigen-Specific CD8+ T Cells for the Treatment of Relapsed or Refractory Multiple Myeloma



- California: City of Hope Duarte

- Massachusetts: Dana-Farber Cancer Institute/Harvard Cancer Center Boston

- New York: Memorial Sloan-Kettering Cancer Center New York

- Texas: The University of Texas MD Anderson Cancer Center Houston

- Michigan: Karmanos Cancer Institute Detroit

- Florida: Advent Health Medical Group Blood & Marrow Transplant Orlando



United States, California

United States, Florida

United States, Massachusetts

United States, Michigan

United States, New York

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