CLN-978 for Lupus

Recruiting at 11 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

Trial Summary

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.

What is the purpose of this trial?

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+