A Study to Evaluate a Novel Gene Therapy in Patients With Relapsed and Refractory Multiple Myeloma (inMMyCAR)

April 22, 2026 updated by: Kelonia Therapeutics, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Contact:
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Paula Fox Melanoma and Cancer Centre
        • Contact:
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Contact:
        • Principal Investigator:
          • Scott Goldsmith, MD
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University
        • Contact:
        • Principal Investigator:
          • Surbhi Sidana, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
        • Contact:
        • Principal Investigator:
          • Nisha Joseph, MD
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Contact:
        • Principal Investigator:
          • Stacey Lewis, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KLN-1010
Drug: KLN-1010 specified dose given once
Drug: KLN-1010
Given at specified dose one time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
All adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) or American Society for Transplantation and Cell Therapy (ASTCT) criteria
Up to 15 years from dosing of KLN-1010

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of KLN-1010 after dosing.
Time Frame: Up to two years after dosing with study drug.
Peak of virus vector genomes (Cmax of lentivirus) in blood.
Up to two years after dosing with study drug.
Pharmacokinetics of KLN-1010 (Tmax).
Time Frame: Up to two years after infusion with study drug.
Measurement of time to the highest amount of viral vector in the blood.
Up to two years after infusion with study drug.
Pharmacokinetics of KLN-1010 Area Under the Curve (AUC)
Time Frame: Up to two years after infusion with study drug.
Measurement of the amount of viral vector (AUC of lentivirus) in blood over time.
Up to two years after infusion with study drug.
Pharmacokinetics of CAR-T cells generated.
Time Frame: Up to two years after infusion with study drug.
The presence and number of CAR-T (Cmax) cells present in blood.
Up to two years after infusion with study drug.
Pharmacokinetics of CAR-T cells generated (Tmax).
Time Frame: Up to two years after infusion with study drug.
Measurement of time to the highest amount of CAR-T cells in the blood.
Up to two years after infusion with study drug.
Pharmacokinetics of CAR-T cells generated Area Under the Curve (AUC)
Time Frame: Up to two years after infusion with study drug.
Measurement of the amount of CAR-T cell DNA in blood and bone marrow over time.
Up to two years after infusion with study drug.
Assessment of Multiple Myeloma
Time Frame: From dosing until disease progression or up to 15 years from receiving study drug, whichever happens first.
Participants will have multiple myeloma assessed according to the International Myeloma Working Group (IMWG) response criteria.
From dosing until disease progression or up to 15 years from receiving study drug, whichever happens first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kelonia Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2042

Study Registration Dates

First Submitted

July 2, 2025

First Submitted That Met QC Criteria

July 18, 2025

First Posted (Actual)

July 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KLN-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Kelonia will make individual anonymized participant data available to qualified researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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