A Study to Evaluate a Novel Gene Therapy in Patients With Relapsed and Refractory Multiple Myeloma
Phase 1 – testing safety in a small group of people
Conditions:
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
Sponsor: Kelonia Therapeutics, Inc.
trial.available_in:
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Overview
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.
Who can participate
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
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