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CAR T-cell Therapy

CLN-978 for Lupus

Phase 1
Recruiting
Research Sponsored by Cullinan Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Active SLE disease, as demonstrated by a SLEDAI total score ≥8 at screening.
* If on corticosteroid and/or antimalarial, the dose must be stable prior to day 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights
No Placebo-Only Group

Summary

"This trial is testing a new drug called CLN-978 given as a shot under the skin to patients with moderate to severe Systemic Lupus Erythematosus (SLE)."

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this is an early phase trial for CLN-978, detailed side effects are not yet fully known. However, similar medications can cause immune reactions, infections due to lowered immunity, infusion-related reactions like pain or swelling where injected, fatigue, and possible blood abnormalities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lupus is active with a SLEDAI score of 8 or higher.
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My corticosteroid or antimalarial medication dose has been stable.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and tolerability
Secondary study objectives
Immunogenicity
Pharmacodynamics-related biomarker
Pharmacokinetics
Other study objectives
Physicians Global Assessment
hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

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Who is running the clinical trial?

Cullinan Therapeutics Inc.Lead Sponsor
8 Previous Clinical Trials
1,022 Total Patients Enrolled
~16 spots leftby Dec 2026
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