NCT07075185RecruitingPhase 1
A Study to Evaluate a Novel Gene Therapy in Patients With Relapsed and Refractory Multiple Myeloma
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
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 2 Jul 2025
- Start date
- 16 Jul 2025
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Kelonia Therapeutics, Inc.
- Diseases
- Multiple myeloma
- NCT number
- NCT07075185
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 70
- From 16 Jul 2025 to the primary completion date, 31 Mar 2027
- 11 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Participants must not have known central nervous system (CNS) involvement with myeloma
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Royal Prince Alfred Coordinator of this site? Confirm its status | Camperdown | Australia | Recruiting |
| The Alfred Paula Fox Melanoma and Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Emory University Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| John Theurer Cancer Center, Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| Providence Portland Medical Center Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| UCSF Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.