Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07075185




Registration number
NCT07075185
Ethics application status
Date submitted
2/07/2025
Date registered
20/07/2025
Date last updated
2/09/2025

Titles & IDs
Public title
A Study to Evaluate a Novel Gene Therapy in Patients With Relapsed and Refractory Multiple Myeloma
Scientific 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
Secondary ID [1] 0 0
KLN-001
Universal Trial Number (UTN)
Trial acronym
inMMyCAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma in Relapse 0 0
Myeloma Multiple 0 0
Multiple Myeloma Progression 0 0
Neoplasms by Histologic Type 0 0
Neoplasm 0 0
Hemostatic Disorders 0 0
Vascular Disorder 0 0
Paraproteinemias 0 0
Blood Protein Disorders 0 0
Hematologic Disease and Disorders 0 0
Lymphoproliferative Disorders 0 0
Immunoproliferative Disorders 0 0
Immune System Disease 0 0
Gene Therapy 0 0
Condition category
Condition code
Cancer 0 0 0 0
Any cancer
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Blood 0 0 0 0
Other blood disorders
Blood 0 0 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - KLN-1010

Experimental: KLN-1010 - Drug: KLN-1010 specified dose given once


Treatment: Drugs: KLN-1010
Given at specified dose one time
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of treatment-emergent adverse events (TEAEs), including dose-limiting toxicities (DLTs), and/or establish the recommended Phase 2 Dose
Timepoint [1] 0 0
Up to 15 years from dosing of KLN-1010
Secondary outcome [1] 0 0
Pharmacokinetics of KLN-1010 after dosing.
Timepoint [1] 0 0
Up to two years after dosing with study drug.
Secondary outcome [2] 0 0
Pharmacokinetics of KLN-1010 (Tmax).
Timepoint [2] 0 0
Up to two years after infusion with study drug.
Secondary outcome [3] 0 0
Pharmacokinetics of KLN-1010 Area Under the Curve (AUC)
Timepoint [3] 0 0
Up to two years after infusion with study drug.
Secondary outcome [4] 0 0
Pharmacokinetics of CAR-T cells generated.
Timepoint [4] 0 0
Up to two years after infusion with study drug.
Secondary outcome [5] 0 0
Pharmacokinetics of CAR-T cells generated (Tmax).
Timepoint [5] 0 0
Up to two years after infusion with study drug.
Secondary outcome [6] 0 0
Pharmacokinetics of CAR-T cells generated Area Under the Curve (AUC)
Timepoint [6] 0 0
Up to two years after infusion with study drug.
Secondary outcome [7] 0 0
Assessment of Multiple Myeloma
Timepoint [7] 0 0
From dosing until disease progression or up to 15 years from receiving study drug, whichever happens first.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/07/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2042
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
The Royal Prince Alfred - Camperdown
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 0 0
The Alfred Paula Fox Melanoma and Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment postcode(s) [3] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Kelonia Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
SVP Clinical Development
Address 0 0
Country 0 0
Phone 0 0
617-223-7349
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Kelonia will make individual anonymized participant data available to qualified researchers.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07075185