KLN-1010 gene therapy for relapsed or refractory multiple myeloma
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
This Phase 1 trial will try KLN-1010, an in vivo CAR‑T gene therapy, to see if it is safe and can be given at a tolerable dose for people with relapsed or refractory multiple myeloma who have had at least three prior therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kelonia Therapeutics, Inc. Industry-sponsored |
| Locations | 7 sites (Duarte, California and 6 other locations) |
| Trial ID | NCT07075185 on ClinicalTrials.gov |
What this trial studies
KLN-1010 is an in vivo CAR‑T gene therapy administered in a Phase 1 dose‑finding design to identify a recommended Phase 2 dose and to monitor safety and tolerability. The trial enrolls adults with measurable relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor, an IMiD, and a CD38‑directed antibody, and who have ECOG performance status 0–1 and acceptable laboratory values. Escalating doses of KLN-1010 will be given at academic sites to define dose‑limiting toxicities and dosing parameters. Secondary data on anti-myeloma activity and duration of response will be collected to inform further development.
Who should consider this trial
Good fit: Adults with relapsed or refractory multiple myeloma with measurable disease who have had at least three prior lines of therapy including a proteasome inhibitor, an IMiD, and an anti‑CD38 antibody, with ECOG 0–1 and acceptable laboratory tests, and no CNS involvement or active systemic infection.
Not a fit: Patients with plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, primary light chain amyloidosis, known CNS myeloma, ongoing acute systemic infection, or those requiring systemic steroids are not eligible and therefore would not benefit from this trial.
Why it matters
Potential benefit: If successful, KLN-1010 could provide a new CAR‑T–style option that may control disease in heavily pretreated myeloma patients without the need for individualized cell collection.
How similar studies have performed: Autologous BCMA‑directed CAR‑T therapies have shown high response rates in relapsed myeloma, but in vivo gene‑delivery CAR‑T approaches like KLN-1010 are novel and have limited human data to date.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Duarte, California and 6 other locations
- City of Hope — Duarte, California, United States (Recruiting)
- Stanford University — Palo Alto, California, United States (Recruiting)
- Emory University Hospital — Atlanta, Georgia, United States (Recruiting)
- Providence Portland Medical Center — Portland, Oregon, United States (Recruiting)
- The Royal Prince Alfred — Camperdown, New South Wales, Australia (Recruiting)
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (Recruiting)
- The Alfred Paula Fox Melanoma and Cancer Centre — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: SVP Clinical Development
- Email: clinicaltrials@keloniatx.com
- Phone: 617-223-7349
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.