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Clinical Trials in Australia / NCT07075185
Recruiting Phase 1

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

NCT07075185 · tracked via the Priya Life Science Australia tracker
Sponsor
Kelonia Therapeutics, Inc
Phase
Phase 1
Started
2025-07-16
Last updated
2026-08-28

Condition(s) studied

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

Investigational drug(s) / intervention(s)

KLN-1010

KLN-1010: Given at specified dose one time

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence and severity of treatment-emergent adverse events (TEAEs), including dose-limiting toxicities (DLTs), and/or establish the recommended Phase 2 Dose — Up to 15 years from dosing of KLN-1010
    All adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) or American Society for Transplantation and Cell Therapy (ASTCT) criteria

Trial sites (11)

FacilityCityRegionStatus
City of Hope Duarte California Recruiting
Stanford University Palo Alto California Recruiting
UCSF San Francisco California Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Emory University Hospital Atlanta Georgia Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
John Theurer Cancer Center, Hackensack University Medical Center Hackensack New Jersey Recruiting
Providence Portland Medical Center Portland Oregon Recruiting
The Royal Prince Alfred Camperdown New South Wales Recruiting
Peter MacCallum Cancer Centre Melbourne Victoria Recruiting
The Alfred Paula Fox Melanoma and Cancer Centre Melbourne Victoria Recruiting

Other trials for the same condition

A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy Recruiting
A Study of HL40626S Tablets in Healthy Adults Starting soon
CHAPTER: Clonal Haematopoiesis Assessment: Prevention, Treatment and Research Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07075185 on ClinicalTrials.gov ↗ ← All trials in Australia