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
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