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

NCT ID: NCT07075185

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-16

Study Completion Date

2042-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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KLN-1010

Drug: KLN-1010 specified dose given once

Group Type EXPERIMENTAL

KLN-1010

Intervention Type DRUG

Given at specified dose one time

Interventions

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KLN-1010

Given at specified dose one time

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kelonia Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Royal Prince Alfred

Camperdown, New South Wales, Australia

Site Status RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Site Status RECRUITING

The Alfred Paula Fox Melanoma and Cancer Centre

Melbourne, Victoria, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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SVP Clinical Development

Role: CONTACT

617-223-7349

Facility Contacts

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Dr. Jose Valencia-Klug

Role: primary

+61 2 9515 5721

Hannah Pahl

Role: primary

+61 3 8559 7851

Prof. Andrew Spencer

Role: primary

+61 3 9076 2000

Other Identifiers

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KLN-001

Identifier Type: -

Identifier Source: org_study_id

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