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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
KLN-1010 		Drug: KLN-1010 specified dose given once
  • Drug: KLN-1010
    Given at specified dose one time

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Noopur Raje, MD
617-724-4000
nraje@mgb.org

More Details

Status
Recruiting
Sponsor
Kelonia Therapeutics, Inc.

Study Contact

SVP Clinical Development
617-223-7349
clinicaltrials@keloniatx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.