ClinTrial Refer

Trial Acronym
KLN-001

Registration Number
NCT07075185

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

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.

* 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

* 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

Trial Location Name

Address

Status

Royal Prince Alfred Hospital (Haematology)

50 Missenden Rd, Camperdown NSW 2050, Australia

Recruiting

Primary Contact : Hayati Vyas, hayati.vyas@health.nsw.gov.au , 02 9515 2492

Secondary Contact : Dr Jessica Ling, jessica.ling5@health.nsw.gov.au , 9515 7563

Kelonia Therapeutics, Inc.

Website URL

Link Name

Link URL

Clinicaltrials.gov

https://clinicaltrials.gov/ct2/show/NCT07075185

ANZCTR

http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=NCT07075185

Secondary IDs
KLN-001

Study Type
Interventional

Intervention Code
Diagnosis / prognosis

Phase
Phase 1

Minimum Age
18

Maximum Age
100

Date Registered
19/08/2025

Date Closed
N/A

Status
Open

Enrolment Type
By Specialist and/or Surgeon Referral

Mutation Status and Biomarker
Any or not stated

Is it a Cohort Trial?
No

Is this a Tele-Trial?
No

Can healthy volunteer participate?
No

Discipline

Health Condition

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