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NCT Number: NCT07075185

A Study to Evaluate a Novel Gene Therapy 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.

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Key information

Conditions

Multiple Myeloma in Relapse Blood Protein Disorders Cardiovascular Diseases Disease Gene Therapy Hematologic Disease and Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Multiple Myeloma Multiple Myeloma Progression Myeloma Multiple Neoplasm Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases Vascular Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Royal Prince Alfred, Camperdown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KLN-1010

Drug

Given at specified dose one time

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

SVP Clinical Development

CONTACT

[email protected]

617-223-7349

Sponsors and collaborators

Lead sponsor

Kelonia Therapeutics, Inc.

Industry

Registry information

Official study title

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

Acronym: inMMyCAR

Important dates

Study start
2025
Primary completion
2027
Study completion
2042
First posted
Jul 20, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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