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

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

Recruiting
18 years and older
All
Phase 1

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Overview

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

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

Study details
    Multiple 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

NCT07075185

Kelonia Therapeutics, Inc.

1 August 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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