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

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.

Sponsor

NexImmune Inc.

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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

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