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A Study to Evaluate a Novel Gene Therapy in Patients With Relapsed and Refractory Multiple Myeloma
RECRUITINGPhase 1Sponsored by Kelonia Therapeutics, Inc.
Actively Recruiting
PhasePhase 1
SponsorKelonia Therapeutics, Inc.
Started2025-07-16
Est. completion2027-03
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations4 sites
View on ClinicalTrials.gov →
NCT07075185
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
Age: 18 Years+Healthy volunteers accepted
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
Conditions15
Blood Protein DisordersCancerGene TherapyHematologic Disease and DisordersHemostatic DisordersImmune System DiseaseImmunoproliferative DisordersLymphoproliferative DisordersMultiple Myeloma ProgressionMultiple Myeloma in Relapse
Interventions1
Locations4 sites
California
2 sitesGeorgia
1 siteEmory University Hospital
Oregon
1 siteProvidence Portland Medical Center
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
PhasePhase 1
SponsorKelonia Therapeutics, Inc.
Started2025-07-16
Est. completion2027-03
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations4 sites
View on ClinicalTrials.gov →
NCT07075185