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Antigen-specific T Cell Therapy for Patients With Relapsed Refractory Multiple Myeloma

NCT04505813 · Status: SUSPENDED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-01-16

No results posted yet for this study

Summary

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.

Conditions

  • Relapsed Refractory Multiple Myeloma

Interventions

BIOLOGICAL

NEXI-002 T Cells

The NEXI-001 T cell product will be administered as a single IV infusion to patients within 72 hours after completing LD therapy.

Sponsors & Collaborators

  • NexImmune Inc.

    lead INDUSTRY

Principal Investigators

  • Kristi Jones · NexImmune

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-17
Primary Completion
2024-11-30
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04505813 on ClinicalTrials.gov