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.
The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
The following criteria is provided for health care professionals.
Previous therapy consisting of at least three (3) standard regimens, including a proteasome inhibitor, IMiD, or anti-CD38 targeting therapy.
Note: Induction therapy, autologous stem cell transplantation (ASCT) & maintenance therapy if given sequentially without intervening progressive disease (PD) are considered one 'regimen'
Have measurable disease as defined by:
Acceptable laboratory parameters as follows:
a. Intermittent topical, inhaled or intranasal corticosteroids are allowed
a. Patients who had HCV but have received an antiviral treatment and show no detectable HCV viral DNA for 6 months are eligible
a. Patients with remote history of seizures that are well controlled on anti-seizure medications and without any seizure episode for 6 months are eligible
The following is a listing of trial locations that are open and accepting patients.
The following is a listing of trial locations that are not currently open and accepting patients.
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