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

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: NexImmune Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Kristi Jones

Principal Investigator

NexImmune

Eligibility Criteria

Inclusion Criteria

Ability to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures that are not part of standard-of-care for the patient's disease. Patients must also be willing and able to comply with study procedures, including the acquisition of specified research specimens

Age ≥ 18 years old & life expectancy > 3 months

Expression of HLA-A*0201 as determined by high resolution sequence-based typing method

See 7 more

Treatment Details

Interventions

NEXI-002 T Cells (CAR T-cell Therapy)

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Safety Evaluation PhaseExperimental Treatment1 Intervention

Treatment with NEXI-002 T cells, derived from PBMCs of the patient

Group II: Dose Expansion PhaseExperimental Treatment1 Intervention

Dose Expansion Phase to further define the safety, tolerability and initial anti-tumor efficacy of the NEXI- 002 T cell product at the dose established from the Safety Evaluation Phase.