CLN-978 for Lupus

Recruiting at 17 trial locations

Overseen By Meagan Sardinha

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Cullinan Therapeutics Inc.

Must be taking: Corticosteroids, Antimalarials

Must not be taking: Anti-CD19, Anti-CD20

Disqualifiers: Active inflammatory disease, Thrombosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called CLN-978 for individuals with moderate to severe Systemic Lupus Erythematosus (SLE), a condition where the immune system attacks the body. The trial will explore how different doses of CLN-978 can help manage lupus symptoms. Suitable participants are those diagnosed with SLE for over six months who have not found success with at least two standard lupus treatments, such as oral steroids or antimalarials. 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 treatment.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it requires that if you are on corticosteroids or antimalarials, the dose must be stable before starting the trial. Some treatments, like non-biologic DMARDs, must be stopped at least 14 days before the trial begins.

Is there any evidence suggesting that CLN-978 is likely to be safe for humans?

Research shows that CLN-978 is being tested for safety in treating lupus. This treatment is administered as an injection under the skin and targets specific cells in the immune system. The primary goal is to determine if it can be used without causing serious side effects.

In earlier lab tests, CLN-978 showed promise, but limited information exists on its effects in humans. Early-stage trials like this one focus on assessing safety. As a Phase 1 trial, it marks the first time CLN-978 is tested in people with lupus, so safety data is still being collected.

Participation in this trial helps researchers learn about potential side effects and the body's response to the treatment. If CLN-978 resembles other immune system treatments, common issues might include mild reactions at the injection site or flu-like symptoms.

Overall, joining this trial contributes to important early research on the safety of CLN-978 for lupus patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for lupus, which often involves immunosuppressants or corticosteroids, CLN-978 offers a new approach by specifically targeting underlying disease mechanisms. Researchers are excited about CLN-978 because it potentially modulates the immune system in a more targeted way, which could lead to fewer side effects compared to current treatments. Additionally, CLN-978's unique mechanism may provide faster relief of symptoms, offering hope for a quicker improvement in patients' quality of life.

What evidence suggests that CLN-978 might be an effective treatment for Lupus?

Research shows that CLN-978, the investigational treatment tested in this trial for lupus, targets a protein called CD19 found on B cells. B cells, part of the immune system, can cause issues in lupus by attacking the body's own tissues. In lab tests, CLN-978 destroyed these harmful B cells and activated T cells, another type of immune cell. These actions might help lessen the damaging effects of lupus. Early studies with cells from both healthy individuals and those with lupus showed similar positive results, suggesting CLN-978 could potentially be effective in treating lupus. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for people with moderate to severe Systemic Lupus Erythematosus (SLE) who haven't responded well to at least two standard treatments, including immunosuppressants or biologics. Participants must have been diagnosed with SLE at least 24 weeks ago and meet specific criteria, including certain blood cell counts and the presence of particular autoantibodies.

Inclusion Criteria

I was diagnosed with SLE over 24 weeks ago and meet specific criteria.

My blood test shows I have enough B cells.

My white blood cell count is within a healthy range.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CLN-978 subcutaneously in dose escalation and further dose evaluation cohorts

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CLN-978

Trial Overview The study is testing CLN-978, a new medication given as an under-the-skin injection for treating SLE. It's in Phase 1b, which means it's early in human trials and focuses on finding out how safe it is and what effects it has on patients with active lupus symptoms.

How Is the Trial Designed?

Group I: Part B Further Dose Evaluation Experimental Treatment 1 Intervention

Further evaluation of CLN-978 treatment of patients with SLE

Group II: Part A Dose Escalation Experimental Treatment 1 Intervention

Patients with SLE treated with CLN-978 in dose escalation cohorts

Who Is Running the Clinical Trial?

Cullinan Therapeutics Inc.

Lead Sponsor

Trials

9

Recruited

1,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06613360

NCT06613360 | A Study of CLN-978, a Subcutaneously ... Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).

2. acrabstracts.org acrabstracts.org/abstract/cln-978-a-cd19-directed-t-cell-engager-tce-leads-to-rapid-and-deep-b-cell-depletion-and-has-broad-potential-for-development-in-autoimmune-diseases/

CLN-978, a CD19-directed T Cell Engager (TCE), Leads to ... Results: In vitro, CLN-978 induced relatively similar B cell killing, T cell activation and cytokine production in PBMCs from healthy donors and SLE patients.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12444481/

Novel cell therapies for systemic lupus erythematosus - PMC A phase 1 clinical trial was conducted to assess the safety, pharmacokinetics, and immunogenicity of CLN-978 for treatment of moderate to severe ...

4. lupus.org lupus.org/resources/cln978

CLN-978 The purpose of the study is to assess the safety, potential effectiveness, and effects of the drug on biologic markers of CLN-978 in people who ...

5. cullinantherapeutics.com cullinantherapeutics.com/science/pipeline/

Pipeline Our pipeline includes potential first or best-in-class molecules. Learn about the development stages of our autoimmune and oncology clinical-stage assets.

6. investors.cullinantherapeutics.com investors.cullinantherapeutics.com/node/9121/pdf

Cullinan Therapeutics Announces Preclinical Data for CLN ... The primary objective of the study is to evaluate the safety of CLN-978 for treatment of active moderate to severe SLE. Secondary objectives ...

7. clinicaltrialsarena.com clinicaltrialsarena.com/news/cullinan-sle-treatment-trial/

Australian HREC grants clearance for Cullinan's SLE ... The trial aims to evaluate the safety, pharmacokinetics, and preliminary clinical activity of CLN-978 in SLE patients. Go deeper with GlobalData.