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

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

  • 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

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