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

Not Applicable

Recruiting

• Conditions: Multiple Myeloma in Relapse; Myeloma Multiple; Multiple Myeloma Progression; Neoplasms by Histologic Type; Neoplasm; Hemostatic Disorders; Vascular Disorder; Paraproteinemias; Blood Protein Disorders; Hematologic Disease and Disorders
• Interventions: Drug: KLN-1010

• Registration Number: NCT07075185
• Lead Sponsor: Kelonia Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted: 2025-07-02
• Study First Submitted QC: 2025-07-18
• Study First Posted: 2025-07-20
• Last Update Submitted: 2025-07-22
• Last Update Posted: 2025-07-25
• Primary Completion: 2027-03
• Study Completion: 2042-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
KLN-1010	KLN-1010	Drug: KLN-1010 specified dose given once

Primary Outcome Measures

Name	Time	Method
Incidence and severity of treatment-emergent adverse events (TEAEs), including dose-limiting toxicities (DLTs), and/or establish the recommended Phase 2 Dose	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 Outcome Measures

Name	Time	Method
Pharmacokinetics of KLN-1010 after dosing.	Up to two years after dosing with study drug.	Peak of virus vector genomes (Cmax of lentivirus) in blood.
Pharmacokinetics of KLN-1010 (Tmax).	Up to two years after infusion with study drug.	Measurement of time to the highest amount of viral vector in the blood.
Pharmacokinetics of KLN-1010 Area Under the Curve (AUC)	Up to two years after infusion with study drug.	Measurement of the amount of viral vector (AUC of lentivirus) in blood over time.
Pharmacokinetics of CAR-T cells generated.	Up to two years after infusion with study drug.	The presence and number of CAR-T (Cmax) cells present in blood.
Pharmacokinetics of CAR-T cells generated (Tmax).	Up to two years after infusion with study drug.	Measurement of time to the highest amount of CAR-T cells in the blood.
Pharmacokinetics of CAR-T cells generated Area Under the Curve (AUC)	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.
Assessment of Multiple Myeloma	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.

Trial Locations

Locations (3)

The Royal Prince Alfred; 🇦🇺 Camperdown, New South Wales, Australia

Peter MacCallum Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia

The Alfred Paula Fox Melanoma and Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia