Multiple Myeloma in RelapsePhase 1inMMyCARNCT07075185
A Study to Evaluate a Novel Gene Therapy in Patients With Relapsed and Refractory Multiple Myeloma
A Phase 1 study testing KLN-1010 in people with Multiple Myeloma in Relapse and Myeloma Multiple, run by Kelonia Therapeutics, Inc. at 11 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma in Relapse, Myeloma Multiple, Multiple Myeloma Progression
- What is being tested?
- KLN-1010
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 16 Jul 2025to May 2042
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 2 countries
United States8 sites, 8 recruiting
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Bryan Burton, 404-778-1780, Bryan.james.burton@emory.edu
Nisha Joseph, MD
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Noopur Raje, MD, 617-724-4000, nraje@mgb.org
Noopur Raje, MD
- Recruiting
City of Hope
Duarte, California, 91010
Scott Goldsmith, MD, 626-218-2405, sgoldsmith@coh.org
Scott Goldsmith, MD
- Recruiting
John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, 07601
Palka Anand, 551-996-3040, Palka.Anand@hmhn.org
David Siegel, MD
- Recruiting
Stanford University
Palo Alto, California, 94304
Sharan Claire, 650-721-4091, sharanclaire@stanford.edu
Surbhi Sidana, MD
- Recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
Laurel Brookhyser, 503-215-1979, canrsrchstudies@providence.org
Stacey Lewis, MD
- Recruiting
UCSF
San Francisco, California, 94143
UCSF Cancer Immunotherapy, 415-353-2421, hdfccc.cip@ucsf.edu
Jodi Lipof, MD
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
ICETtrials@moffitt.org
Ciara Freeman, MD, MSc, PhD
Australia3 sites, 3 recruiting
- Recruiting
The Royal Prince Alfred
Camperdown, New South Wales, 2050
Dr. Jose Valencia-Klug, +61 2 9515 5721, jose.valencia-klug@health.nsw.gov.au
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Hannah Pahl, +61 3 8559 7851, PCCTU.HaemC@petermac.org
- Recruiting
The Alfred Paula Fox Melanoma and Cancer Centre
Melbourne, Victoria, 3004
Prof. Andrew Spencer, +61 3 9076 2000, andrew.spencer@monash.edu
About this study
Official 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.
- Conditions
- Multiple Myeloma in Relapse, Myeloma Multiple, Multiple Myeloma Progression, Neoplasms by Histologic Type, Neoplasm, Hemostatic Disorders
- Being tested
- KLN-1010
- Keywords
- in vivo CAR-T, multiple myeloma, gene therapy, BMCA
- Medical subject headings
- Multiple Myeloma, Neoplasms by Histologic Type, Neoplasms, Hemostatic Disorders, Vascular Diseases, Paraproteinemias, Blood Protein Disorders, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KLN-1010Drug
Given at specified dose one time
| Study group | Role | What they receive |
|---|---|---|
| KLN-1010 | Experimental | Drug: KLN-1010 specified dose given once Receives: Drug: KLN-1010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 15 years from dosing of KLN-1010
Secondary outcomes (7)
Pharmacokinetics of KLN-1010 after dosing.
Peak of virus vector genomes (Cmax of lentivirus) in blood.
Measured: Up to two years after dosing with study drug.
Pharmacokinetics of KLN-1010 (Tmax).
Measurement of time to the highest amount of viral vector in the blood.
Measured: Up to two years after infusion with study drug.
Pharmacokinetics of KLN-1010 Area Under the Curve (AUC)
Measurement of the amount of viral vector (AUC of lentivirus) in blood over time.
Measured: Up to two years after infusion with study drug.
Pharmacokinetics of CAR-T cells generated.
The presence and number of CAR-T (Cmax) cells present in blood.
Measured: Up to two years after infusion with study drug.
Pharmacokinetics of CAR-T cells generated (Tmax).
Measurement of time to the highest amount of CAR-T cells in the blood.
Measured: Up to two years after infusion with study drug.
Pharmacokinetics of CAR-T cells generated Area Under the Curve (AUC)
Measurement of the amount of CAR-T cell DNA in blood and bone marrow over time.
Measured: Up to two years after infusion with study drug.
Assessment of Multiple Myeloma
Participants will have multiple myeloma assessed according to the International Myeloma Working Group (IMWG) response criteria.
Measured: From dosing until disease progression or up to 15 years from receiving study drug, whichever happens first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start16 Jul 2025
- Primary completionMar 2027 (estimated)
- Study completionMay 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma in RelapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kelonia Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075185
- Sponsor's protocol ID
- KLN-001
- Acronym
- inMMyCAR
- Status last verified
- Aug 2025
- First submitted
- 2 Jul 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Kelonia will make individual anonymized participant data available to qualified researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07075185
- Acronym / sponsor ID
- inMMyCAR / KLN-001
- Conditions
- Multiple Myeloma in Relapse, Myeloma Multiple, Multiple Myeloma Progression, Neoplasms by Histologic Type, Neoplasm, Hemostatic Disorders
- Keywords
- in vivo CAR-T, multiple myeloma, gene therapy, BMCA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Kelonia Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2042 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KLN-1010 | Experimental | Drug: KLN-1010Drug: KLN-1010 specified dose given once |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KLN-1010Given at specified dose one time | Drug | KLN-1010 |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs), including dose-limiting toxicities (DLTs), and/or establish the recommended Phase 2 Dose
Time frame: 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
7 secondary outcomes
Pharmacokinetics of KLN-1010 after dosing.
Time frame: Up to two years after dosing with study drug.
Pharmacokinetics of KLN-1010 (Tmax).
Time frame: Up to two years after infusion with study drug.
Pharmacokinetics of KLN-1010 Area Under the Curve (AUC)
Time frame: Up to two years after infusion with study drug.
Pharmacokinetics of CAR-T cells generated.
Time frame: Up to two years after infusion with study drug.
Pharmacokinetics of CAR-T cells generated (Tmax).
Time frame: Up to two years after infusion with study drug.
Pharmacokinetics of CAR-T cells generated Area Under the Curve (AUC)
Time frame: Up to two years after infusion with study drug.
Assessment of Multiple Myeloma
Time frame: From dosing until disease progression or up to 15 years from receiving study drug, whichever happens first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Yes. Kelonia will make individual anonymized participant data available to qualified researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KLN-1010 in people with Multiple Myeloma in Relapse and Myeloma Multiple, run by Kelonia Therapeutics, Inc. at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Development (857-281-6726, clinicaltrials@keloniatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events (TEAEs), including dose-limiting toxicities (DLTs), and/or establish the recommended Phase 2 Dose (time frame: Up to 15 years from dosing of KLN-1010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.