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

40 participants

Start Date

Jul 16, 2025

Study Type

INTERVENTIONAL

Conditions

Neoplasm Lymphoproliferative Disorders Neoplasms by Histologic Type Multiple Myeloma in Relapse Myeloma, Multiple Multiple Myeloma Progression Hemostatic Disorders Vascular Disorder Paraproteinemias Blood Protein Disorders Hematologic Disease and Disorders Immunoproliferative Disorders Immune System Disease Gene Therapy

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

Inclusion Criteria4

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 Criteria4

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

DRUGKLN-1010

Given at specified dose one time

Locations(3)

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

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NCT07075185

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