CLN-978 for Lupus

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

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

Trial Summary

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).

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.

Research Team

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.

See 7 more

Trial 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 (CAR T-cell Therapy)

Trial OverviewThe 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

2Treatment groups

Experimental Treatment

Group I: Part B Further Dose EvaluationExperimental Treatment1 Intervention

Further evaluation of CLN-978 treatment of patients with SLE

Group II: Part A Dose EscalationExperimental Treatment1 Intervention

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