A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus

Part of paid clinical trials in Avondale, Arizona.

Sponsor
Cullinan Therapeutics Inc.
Study ID
NCT06613360
Phase
PHASE1
Status
Recruiting

Conditions

  • SLE
  • SLE (Systemic Lupus)

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • CLN-978 — DRUG
    Specified dose on specified days

Study Details

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

Key Dates

Start date
Jan 21, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

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

Arms

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

Primary Outcome Measure

Safety and tolerability [ Time Frame: 48 weeks ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
AARA Clinical ResearchAvondaleArizona85392
Danaira Vasquez
602-386-4971
AARA Clinical ResearchTucsonArizona85704
Mikayla Kirby
520-867-6906
Omega Research GroupOrlandoFlorida32808
Audrey Treadway
386-668-4202
University of IowaIowa CityIowa52242
Ashley Pieper
319-356-0765
Columbia University Medical CenterNew YorkNew York10032-
University of Rochester Medical CenterRochesterNew York14642
Maria Allen
585-275-7167
Regional One HealthMemphisTennessee38103
Kimberly Barbee
901-515-4520
Stryde ResearchPlanoTexas75093
Aarsheya Amin
214-884-7721
Tranquil Clinical ResearchWebsterTexas77598
Viswakanth Makutam
612-461-3159
Intermountain HealthSalt Lake CityUtah84101
Carrie Rhodes
801-408-4718

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