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

First listed
Jun 27, 2025
Start date
Oct 1, 2025
Status verified
Aug 2026
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 (6)

FacilityCityStateZIPSite coordinators
Omega ResearchOrlandoFlorida32808
Kwabena Ayesu, MD
407-512-1054
New York UniversityBrooklynNew York11201
Abraham Sinay-Smith
Regional OneMemphisTennessee38103
Lisa McKnight
901-633-2531
Stryde ResearchPlanoTexas75093
Mariana Paz
214-884-7787
Tranquil ResearchWebsterTexas77598
Karim Mohammed
713-907-6054
IntermountainSalt Lake CityUtah84143
Joshua Kunz
801-408-4724

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