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

Launched by KELONIA THERAPEUTICS, INC. · Jul 18, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new gene therapy called KLN-001 for people with multiple myeloma, a type of blood cancer that has come back or has not responded to previous treatments. The main goal is to see if this gene therapy is safe and well-tolerated, and to figure out the best dose to use in future studies.

The trial is open to adults aged 65 to 74 who have had multiple myeloma that has returned or not improved after trying at least three different treatments, including specific types of cancer medicines. Participants need to be in reasonably good health overall and not have certain other serious conditions like brain involvement of myeloma or certain rare blood disorders. People in the study will receive the gene therapy and be closely monitored to see how their body responds and if there are any side effects. This early-phase study is an important step toward developing new options for patients with hard-to-treat multiple myeloma.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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