70 Participants NeededMy employer runs this trial

Gene Therapy for Multiple Myeloma

(inMMyCAR Trial)

Recruiting at 10 trial locations
SC
CD
Overseen ByClinical Development
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Kelonia Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new gene therapy treatment called KLN-1010 for individuals with multiple myeloma, a type of blood cancer that has returned or not responded to other treatments. The primary goal is to assess the safety and tolerability of KLN-1010 and determine the optimal dose for future studies. Candidates who have tried at least three different treatments, including a proteasome inhibitor and immunotherapy, and still have measurable disease might be suitable participants. Those with multiple myeloma meeting these criteria and seeking new options may find this trial of interest. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you require systemic steroids for any condition.

Is there any evidence suggesting that KLN-1010 is likely to be safe for humans?

Research has shown that KLN-1010, a new gene therapy for multiple myeloma, is generally safe. Early results suggest that patients tolerate the treatment well. No reports of serious side effects have emerged, which are often a concern with new treatments. Importantly, patients did not experience severe cytokine release syndrome (CRS), a condition that can cause fever and inflammation in some gene therapies. Overall, initial findings indicate KLN-1010 is safe for people, helping it stand out from other similar treatments.12345

Why do researchers think this study treatment might be promising?

KLN-1010 is unique because it represents a cutting-edge approach to treating multiple myeloma through gene therapy. Unlike current treatments such as proteasome inhibitors, immunomodulatory drugs, and monoclonal antibodies, KLN-1010 works by directly altering the genetic material within cancer cells to stop their growth or even kill them. This new mechanism of action has the potential to target the disease more precisely, minimizing the side effects typically associated with traditional chemotherapy. Researchers are excited because this could lead to more effective and personalized treatment options for patients with multiple myeloma.

What evidence suggests that KLN-1010 might be an effective treatment for multiple myeloma?

Research has shown that KLN-1010, the treatment under study in this trial, holds promise for treating multiple myeloma, a type of cancer. In early studies, all patients showed no detectable cancer cells in their blood after treatment, with this effect lasting up to five months. The treatment employs gene therapy to create special cells in the body that directly attack cancer cells. Additionally, no severe side effects were reported, indicating likely safety. These early results suggest KLN-1010 could effectively treat this cancer.12467

Are You a Good Fit for This Trial?

This trial is for adults with multiple myeloma that has come back or not responded to treatment, who have already tried at least three types of standard therapies. Participants need to be in good physical condition and have lab results within safe ranges.

Inclusion Criteria

My multiple myeloma has returned after treatment and is measurable.
I've had 3 types of treatments for my condition, including PI, IMiD, and a CD38 antibody.
I am fully active or can carry out light work.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a specified dose of KLN-1010, a novel gene therapy, to generate anti-BCMA CAR-T cells

Single dose
1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and pharmacokinetics of CAR-T cells and KLN-1010

Up to 2 years
Regular visits (frequency not specified)

Long-term follow-up

Participants are monitored for long-term safety and disease progression

Up to 15 years

What Are the Treatments Tested in This Trial?

Interventions

  • KLN-1010

Trial Overview

The study is testing a new gene therapy called KLN-1010 to find the safest dose and see how well patients tolerate it. All participants will receive this experimental treatment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: KLN-1010Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kelonia Therapeutics, Inc.

Lead Sponsor

Citations

negative outcomes following a novel, in vivo gene therapy ...

Conclusions: Preliminary results from the first three patients dosed in the inMMyCAR Phase 1 study of KLN-1010 demonstrate that promising ...

Kelonia Therapeutics Presents First-in-Human Data from ...

100% MRD-negative response rate in four patients; all remain in response through the longest follow up of 5 months.

NCT07075185 | A Study to Evaluate a Novel Gene ...

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 ...

KLN-1010 In Vivo CAR-T Therapy: Revolutionary Off-the-Shelf ...

All four initial patients achieved remarkable MRD-negative responses within one month that continued deepening over time, with one patient ...

Gene therapy shows promising results against multiple ...

The phase I study underway is designed to evaluate the safety, tolerability and early effectiveness of KLN-1010 and to identify recommended ...

Early Data Show Deep MRD-Negative Responses, CAR T- ...

KLN-1010 showed deep, ongoing MRD-negative responses in relapsed/refractory multiple myeloma with a favorable safety profile. The therapy ...

In Vivo CAR T Cells Deliver Deep Responses in Myeloma

... KLN-1010 recipients experienced CRS to that degree. That safety difference could set the Kelonia product apart—both from other in vivo CAR T ...