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RecruitingNCT07075185inMMyCARUpdated Aug 28, 2026

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

A Phase 1 interventional study of KLN-1010 in Multiple Myeloma in Relapse, Myeloma Multiple and Multiple Myeloma Progression, sponsored by Kelonia Therapeutics, Inc.. Recruiting at 11 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Kelonia Therapeutics, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 3 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • in vivo CAR-T
  • multiple myeloma
  • gene therapy
  • BMCA
03

In context

Multiple Myeloma

3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.

This study's planned enrollment of 70 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

This is the only study on the registry with Kelonia Therapeutics, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants must have multiple myeloma (RRMM) with
  • Participants must have received at least 3 including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and CD38-directed monoclonal antibody
  • Participants must have an Eastern Cooperative Group () performance status of 0-1
  • Participants must have acceptable laboratory values as defined by the protocol

Exclusion criteria

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 for any condition
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    KLN-1010

    Drug: KLN-1010 specified dose given once

    Drug: KLN-1010

Interventions

  • DrugKLN-1010

    Given at specified dose one time

06

What researchers measure

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

    Time frame: Up to 15 years from dosing of KLN-1010

Secondary outcomes

  1. Pharmacokinetics of KLN-1010 after dosing.

    Peak of virus vector genomes (Cmax of lentivirus) in blood.

    Time frame: Up to two years after dosing with study drug.

  2. Pharmacokinetics of KLN-1010 (Tmax).

    Measurement of time to the highest amount of viral vector in the blood.

    Time frame: Up to two years after infusion with study drug.

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

    Measurement of the amount of viral vector (AUC of lentivirus) in blood over time.

    Time frame: Up to two years after infusion with study drug.

  4. Pharmacokinetics of CAR-T cells generated.

    The presence and number of CAR-T (Cmax) cells present in blood.

    Time frame: Up to two years after infusion with study drug.

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

    Measurement of time to the highest amount of CAR-T cells in the blood.

    Time frame: Up to two years after infusion with study drug.

  6. 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.

    Time frame: Up to two years after infusion with study drug.

  7. Assessment of Multiple Myeloma

    Participants will have multiple myeloma assessed according to the International Myeloma Working Group (IMWG) response criteria.

    Time frame: From dosing until disease progression or up to 15 years from receiving study drug, whichever happens first.

07

Study locations

11 of 11 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Kelonia will make individual anonymized participant data available to qualified researchers.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07075185
Lead sponsor
Kelonia Therapeutics, Inc.
Responsible party
Sponsor
First posted
Jul 20, 2025
Start date
Jul 16, 2025
Primary completion
Mar 2027 (estimated)
Completion
May 2042 (estimated)
Last update
Aug 28, 2026

Study contacts

Clinical Development
Contact
clinicaltrials@keloniatx.com
857-281-6726

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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