NCT04505813

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

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

• Status: Suspended
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: NexImmune Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The NEXI-002 is an adoptive cellular therapy product which contains populations of antigen-specific CD8+ T cells. The antigen-specific CD8+ T cells in the NEXI-002 T cell product are derived from Peripheral Blood Mononuclear Cells (PBMC) obtained from the patient. During the manufacturing process, these cells are primed and expanded ex vivo using nano-size artificial Antigen Presenting Cells (aAPC) loaded with five leukemia associated antigen peptides in combination with a proprietary T cell enrichment and expansion process. The NEXI-002 T cell product is restricted to patients that are HLA-A2.01 allele positive for this study. There are two parts to this study, a Safety Evaluation Phase and a Dose Expansion Phase. The Safety Evaluation Phase will determine the safety and tolerability of a single dose of NEXI-002 T cell product, and will consist of Dose Escalation at two dose levels - each with cohorts of three patients. When all three patients at Dose Level 1 have dosed and cleared the DLT period, three additional patients will be enrolled at Dose Level 2. When three patients have cleared the DLT period at the highest dose level, that dose will be advanced to the Dose Expansion Phase. The Dose Expansion Phase will enroll up to 16 additional patients to further define the safety and evaluate the initial anti-tumor efficacy of the NEXI- 002 T cell product at the dose established from the Safety Evaluation Phase. All patients will enter a Post-Treatment Follow-Up period after infusion of the NEXI- 002 T cell product. During this phase, all patients will be monitored for AEs and followed for anti-leukemia response until the end of study visit is complete (up to one year). Additional assessments for safety, disease status, and other secondary and exploratory endpoints will also be monitored during the follow-up period. All patients will be followed for overall survival (OS) from time of disease progression until the last visit of the last patient. During this time, patients will be followed via telephone or other electronic contact at 12 week intervals for monitoring of OS.

Conditions

• Relapsed Refractory Multiple Myeloma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-08-17
• Primary completion: 2024-11-30
• Completion: 2025-12-31
• First posted: 2020-08-10
• Last updated: 2024-01-16

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study