Status:
RECRUITING
A Study to Evaluate a Novel Gene Therapy in Patients With Relapsed and Refractory Multiple Myeloma
Lead Sponsor:
Kelonia Therapeutics, Inc.
Conditions:
Multiple Myeloma in Relapse
Myeloma Multiple
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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
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
Key Trial Info
Start Date :
July 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2042
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07075185
Start Date
July 16 2025
End Date
May 1 2042
Last Update
April 16 2026
Active Locations (7)
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1
City of Hope
Duarte, California, United States, 91010
2
Stanford University
Palo Alto, California, United States, 94304
3
Emory University Hospital
Atlanta, Georgia, United States, 30322
4
Providence Portland Medical Center
Portland, Oregon, United States, 97213