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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
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

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