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A Study to Evaluate a Novel Gene Therapy in Patients With Relapsed and Refractory Multiple Myeloma
RecruitingPhase 1
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
Who can join
Ages 18 and older · All sexes
Full 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
About the study
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.
What is being tested
- KLN-1010 (drug)
Sponsor: Kelonia Therapeutics, Inc. · Participants: 70 · Started: Jul 16, 2025
Contact the study team
- Clinical Development · Phone: 857-281-6726
Official record on ClinicalTrials.gov — NCT07075185
Locations in the U.S.
Conditions
- Multiple Myeloma
- Neoplasms by Histologic Type
- Cancer (all types)
- Vascular Diseases
- Paraproteinemias
- Blood Disorders
- Immune System and Disorders
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.