Actively Recruiting
A Phase 1 Study to Evaluate the Safety of KLN-1010 Gene Therapy to Generate Anti-BCMA CAR-T Cells in Patients With Relapsed and Refractory Multiple Myeloma
Led by Kelonia Therapeutics, Inc. · Updated on 2026-04-24
70
Participants Needed
7
Research Sites
791 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating KLN-1010, a novel gene therapy, in patients with relapsed or refractory multiple myeloma to assess its safety, tolerability, and to determine the recommended Phase 2 dose. The trial is a Phase 1 study sponsored by Kelonia Therapeutics, Inc., focusing on patients who have previously undergone multiple treatments for their condition. Participants receive a single specified dose of KLN-1010, which is designed to generate anti-B Cell Maturation Antigen (anti-BCMA) CAR-T cells in the body. This gene therapy is administered once during the study, and its effects, including safety and pharmacokinetics, are closely monitored over time. During the study, participants undergo assessments for treatment-emergent adverse events and dose-limiting toxicities for up to 15 years after dosing. Pharmacokinetic evaluations of KLN-1010 and generated CAR-T cells occur up to two years post-infusion. Multiple myeloma status is monitored from dosing until disease progression or up to 15 years, with comprehensive safety and disease assessments throughout the follow-up period.
CONDITIONS
Brief Title
A Study to Evaluate a Novel Gene Therapy in Patients With Relapsed and Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have relapsed and refractory multiple myeloma with measurable disease
- Participants must have received at least 3 prior lines of therapy including a proteasome inhibitor, an immunomodulatory drug, and CD38-directed monoclonal antibody
- Participants must have an Eastern Cooperative Group performance status of 0-1
- Participants must have acceptable laboratory values as defined by the protocol
You will not qualify if you...
- Participants must not have known central nervous system involvement with myeloma
- Participants cannot have plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis
- Participants cannot have ongoing acute systemic infection requiring antimicrobial therapy
- Participants cannot require systemic steroids for any condition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 15 years from dosing
Participants receive a one-time dose of the KLN-1010 gene therapy to generate anti-BCMA CAR-T cells.
Follow-up visits for pharmacokinetics and disease assessment up to 2 years after dosing; long-term disease monitoring up to 15 years
Trial Site Locations
Total: 7 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
3
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
5
The Royal Prince Alfred
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
6
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
7
The Alfred Paula Fox Melanoma and Cancer Centre
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
S
SVP Clinical Development
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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