RecruitingPhase 1NCT07075185

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

A Phase 1 Study to Evaluate the Safety of KLN-1010, a Novel, In Vivo Gene Therapy to Generate Anti-B Cell Maturation Antigen (Anti-BCMA) Chimeric Antigen Receptor-T Cells (CAR-T) in Patients With Relapsed and Refractory Multiple Myeloma


Sponsor

Kelonia Therapeutics, Inc.

Enrollment

70 participants

Start Date

Jul 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new gene therapy for people with multiple myeloma — a type of blood cancer — whose cancer has come back or stopped responding to multiple prior treatments. **You may be eligible if...** - You have relapsed or refractory multiple myeloma with measurable disease - You have received at least 3 prior lines of treatment, including a proteasome inhibitor (e.g., bortezomib), an immunomodulatory drug (e.g., lenalidomide), and a CD38-targeting antibody (e.g., daratumumab) - You are in good overall health (ECOG performance status 0–1) - Your blood counts and organ function meet the study requirements **You may NOT be eligible if...** - Your myeloma has spread to the central nervous system (brain/spinal cord) - You have plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis - You have other medical conditions that would make this therapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKLN-1010

Given at specified dose one time


Locations(7)

City of Hope

Duarte, California, United States

Stanford University

Palo Alto, California, United States

Emory University Hospital

Atlanta, Georgia, United States

Providence Portland Medical Center

Portland, Oregon, United States

The Royal Prince Alfred

Camperdown, New South Wales, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

The Alfred Paula Fox Melanoma and Cancer Centre

Melbourne, Victoria, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07075185


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