Recruiting
Phase 1

KLN-1010

Sponsor:

Kelonia Therapeutics, Inc.

Code:

NCT07075185

Conditions

Multiple Myeloma in Relapse

Myeloma Multiple

Multiple Myeloma Progression

Neoplasms by Histologic Type

Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

KLN-1010

Study Details

Brief summary:

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.

Conditions

Multiple Myeloma in Relapse

Myeloma Multiple

Multiple Myeloma Progression

Neoplasms by Histologic Type

Neoplasm

Study ID

NCT07075185

Start date

Jul 16, 2025

Status verified date

Aug, 2025

Completion date

May, 2042

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: KLN-1010

Drug: KLN-1010 specified dose given once

Interventions

KLN-1010

Given at specified dose one time

Primary outcome measure

  • Incidence and severity of treatment-emergent adverse events (TEAEs), including dose-limiting toxicities (DLTs), and/or establish the recommended Phase 2 Dose [ Time Frame: Up to 15 years from dosing of KLN-1010 ]

Central Contacts and Locations

Central contacts

Clinical Development

857-281-6726clinicaltrials@keloniatx.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Scott Goldsmith, MD

626-218-2405sgoldsmith@coh.org

Principal Investigator:

Scott Goldsmith, MD

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Sharan Claire

650-721-4091sharanclaire@stanford.edu

Principal Investigator:

Surbhi Sidana, MD

UCSF

Recruiting

San Francisco, California, United States, 94143

Contacts

UCSF Cancer Immunotherapy

415-353-2421hdfccc.cip@ucsf.edu

Principal Investigator:

Jodi Lipof, MD

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

ICETtrials@moffitt.org

Principal Investigator:

Ciara Freeman, MD, MSc, PhD

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Bryan Burton

404-778-1780Bryan.james.burton@emory.edu

Principal Investigator:

Nisha Joseph, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Noopur Raje, MD

617-724-4000nraje@mgb.org

Principal Investigator:

Noopur Raje, MD

John Theurer Cancer Center, Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Palka Anand

551-996-3040Palka.Anand@hmhn.org

Principal Investigator:

David Siegel, MD

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Laurel Brookhyser

503-215-1979canrsrchstudies@providence.org

Principal Investigator:

Stacey Lewis, MD

More Information

Sponsor

Kelonia Therapeutics, Inc.

Last update posted

Aug 28, 2026

Last verified

Aug, 2025

Keywords

  • in vivo CAR-T
  • multiple myeloma
  • gene therapy
  • BMCA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Kelonia Therapeutics, Inc. on 2026-08-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.