A Study to Evaluate a Novel Gene Therapy in Patients With Relapsed and Refractory Multiple Myeloma

ConditionsMultiple Myeloma in Relapse Myeloma Multiple Multiple Myeloma Progression Neoplasms by Histologic Type Neoplasm Hemostatic Disorders Vascular Disorder Paraproteinemias Blood Protein Disorders Hematologic Disease and Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Disease Gene Therapy

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorKelonia Therapeutics, Inc.

About this trial

The goal of this clinical trial is to evaluate the safety, tolerability, and recommended Phase 2 Dose (RP2D) of KLN-1010 in patients with relapsed or refractory multiple myeloma.

Eligibility criteria

Qualifiers

Participants must have relapsed and refractory multiple myeloma (RRMM) with measurable disease

Participants must have received at least 3 prior lines of therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and CD38-directed monoclonal antibody

Participants must have an Eastern Cooperative Group (ECOG) performance status of 0-1

Participants must have acceptable laboratory values as defined by the protocol

Disqualifiers

Participants must not have known central nervous system (CNS) involvement with myeloma

Participants cannot have plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, or primary light chain amyloidosis

Participants cannot have ongoing acute systemic infection requiring antimicrobial therapy

Participants cannot require systemic steroids for any condition

Trial design

Treatments tested in this trial

KLN-1010

Treatment groups

70 Participants

are divided into 1 treatment group

Sponsors and collaborators

Kelonia Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov