A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease

Part of paid clinical trials in Orlando, Florida.

Sponsor
Cullinan Therapeutics Inc.
Study ID
NCT07041099
Phase
PHASE1
Status
Recruiting

Conditions

  • Sjogren Disease
  • Sjogren's Syndrome
  • Sjögren

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CLN-978 — DRUG
    Specified dose on specified days

Study Details

A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.

Key Dates

Start date
Oct 1, 2025
Status verified
Nov 2025
Primary completion
Mar 15, 2028
Completion
Mar 15, 2029

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A Dose Escalation
    Patients with Sjogren's Disease treated with CLN-978 in dose escalation cohorts
  • Experimental: Part B Further Dose Evaluation
    Further evaluation of CLN-978 treatment of patients with Sjogren's Disease

Primary Outcome Measure

Safety and Tolerability [ Time Frame: 48 weeks ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Cullinan Investigative SiteOrlandoFlorida32808-
Cullinan Investigative SiteMemphisTennessee38103-
Cullinan Investigative SitePlanoTexas75093-
Cullinan Investigative SiteWebsterTexas77598-
Cullinan Investigative SiteSalt Lake CityUtah84107-

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