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NCT07075185PHASE1Recruiting

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

Kelonia Therapeutics, Inc.

Start Date

7/16/2025

Completion Date

5/1/2042

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

KLN-1010

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Multiple Myeloma in RelapseMyeloma MultipleMultiple Myeloma ProgressionNeoplasms by Histologic TypeNeoplasmHemostatic DisordersVascular DisorderParaproteinemiasBlood Protein DisordersHematologic Disease and DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseaseGene Therapy

Locations

City of Hope

Duarte, California 91010

United States

Stanford University

Palo Alto, California 94304

United States

UCSF

San Francisco, California 94143

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Emory University Hospital

Atlanta, Georgia 30322

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Providence Portland Medical Center

Portland, Oregon 97213

United States

The Royal Prince Alfred

Camperdown, New South Wales 2050

Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria 3000

Australia

The Alfred Paula Fox Melanoma and Cancer Centre

Melbourne, Victoria 3004

Australia