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

NCT07075185 | Recruiting Phase 1 FDA Drug

• 1 other identifier: KLN-001
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 7

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 Progression; Vascular Disorder; Paraproteinemias; Immunoproliferative Disorders; Hemostatic Disorders; Blood Protein Disorders; Myeloma Multiple; Neoplasms by Histologic Type; Neoplasm; Hematologic Disease and Disorders; Lymphoproliferative Disorders; Immune System Disease; Gene Therapy; Multiple Myeloma in Relapse

Keywords

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

Outcome Measures

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

  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 Outcomes (7)

• Pharmacokinetics of KLN-1010 after dosing.

  Up to two years after dosing with study drug.

• Pharmacokinetics of KLN-1010 (Tmax).

  Up to two years after infusion with study drug.

• Pharmacokinetics of KLN-1010 Area Under the Curve (AUC)

  Up to two years after infusion with study drug.

• Pharmacokinetics of CAR-T cells generated.

  Up to two years after infusion with study drug.

• Pharmacokinetics of CAR-T cells generated (Tmax).

  Up to two years after infusion with study drug.

Study Arms (1)

KLN-1010

EXPERIMENTAL

Drug: KLN-1010 specified dose given once

Drug: KLN-1010

Interventions

KLN-1010 DRUG

Given at specified dose one time

KLN-1010

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kelonia Therapeutics, Inc.: lead

Study Sites (7)

City of Hope

Duarte, California, 91010, United States

RECRUITING

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

Providence Portland Medical Center

Portland, Oregon, 97213, United States

RECRUITING

The Royal Prince Alfred

Camperdown, New South Wales, 2050, Australia

RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

RECRUITING

The Alfred Paula Fox Melanoma and Cancer Centre

Melbourne, Victoria, 3004, Australia

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Disease; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Cardiovascular Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphatic Diseases

Central Study Contacts

SVP Clinical Development

CONTACT

617-223-7349; clinicaltrials@keloniatx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 20, 2025
• Study Start: July 16, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2042
• Last Updated: April 24, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

AU (3); US (4)