KLN-1010 gene therapy for relapsed or refractory multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• City of Hope
  Duarte, California, United States Recruiting
• Stanford University
  Palo Alto, California, United States Recruiting
• UCSF
  San Francisco, California, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Emory University Hospital
  Atlanta, Georgia, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Clinical Development
• Email: clinicaltrials@keloniatx.com
• Phone: 857-281-6726

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.