Tests KLN-1010, a new gene therapy, in people with relapsed multiple myeloma
Tests KLN-1010, a new gene therapy, in adults with relapsed or refractory multiple myeloma.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate a Novel Gene Therapy in Patients With Relapsed and Refractory Multiple Myeloma
Key facts
- Where
- Atlanta, Boston, Duarte, Hackensack, Palo Alto, Portland, San Francisco, and Tampa, United StatesSee the 8 sites
- Phase
- Phase 1
Where in United States
- Emory University HospitalAtlanta, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- City of HopeDuarte, United StatesTaking people
- John Theurer Cancer Center, Hackensack University Medical CenterHackensack, United StatesTaking people
- Stanford UniversityPalo Alto, United StatesTaking people
- Providence Portland Medical CenterPortland, United StatesTaking people
- UCSFSan Francisco, United StatesTaking people
- Moffitt Cancer CenterTampa, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kelonia Therapeutics, Inc.
- Trial code
- NCT07075185
- Record updated
- 28 August 2026
- Original description
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.Read full original descriptionShow less
A Phase 1 Study to Evaluate the Safety of KLN-1010, a Novel, In Vivo Gene Therapy to Generate Anti-B Cell Maturation Antigen (Anti-BCMA) Chimeric Antigen Receptor-T Cells (CAR-T) in Patients With Relapsed and Refractory Multiple Myeloma
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.
Inclusion: 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: 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; Participants must not have known central nervous system (CNS) involvement with myeloma.