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

Recruiting now · Phase 1

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

In brief

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.

Key facts

Study ID

NCT07075185

Run by

Kelonia Therapeutics, Inc.

People needed

70

Starts

2025-07-16

Expected to finish

2042-05-01

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City of Hope — Duarte, California, United States (enrolling)
• Stanford University — Palo Alto, California, United States (enrolling)
• UCSF — San Francisco, California, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Emory University Hospital — Atlanta, Georgia, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Providence Portland Medical Center — Portland, Oregon, United States (enrolling)
• The Royal Prince Alfred — Camperdown, New South Wales, Australia (enrolling)
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (enrolling)
• The Alfred Paula Fox Melanoma and Cancer Centre — Melbourne, Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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