A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Study ID
NCT05869955
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • CC-97540 — DRUG
    Specified dose on specified days
  • Fludarabine — DRUG
    Specified dose on specified days
  • Cyclophosphamide — DRUG
    Specified dose on specified days
  • Tocilizumab — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).

Key Dates

First listed
May 23, 2023
Start date
Sep 13, 2023
Status verified
Jul 2026
Primary completion
Aug 29, 2028
Completion
Aug 29, 2028

Study Design

Enrollment
270 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Administration of CC-97540

Primary Outcome Measure

Number of participants with treatment-emergent adverse events (AEs) in each indication. [ Time Frame: Up to 2 years after CC-97540 infusion ]

Locations (25)

FacilityCityStateZIPSite coordinators
Local Institution - 0035AuroraColorado80045-
Local Institution - 0024DenverColorado80218-
Local Institution - 0006JacksonvilleFlorida32224-
Local Institution - 0056MiamiFlorida33136-
Local Institution - 0053ChicagoIllinois60612-
Local Institution - 0038BostonMassachusetts02115-
Local Institution - 0033WorcesterMassachusetts01655-
University of Massachusetts Chan Medical SchoolWorcesterMassachusetts01655-
Local Institution - 0031Ann ArborMichigan48109-2800-
Local Institution - 0037DetroitMichigan48202-
Local Institution - 0022RochesterMinnesota55905-
Local Institution - 0010St LouisMissouri63110-
Local Institution - 0028OmahaNebraska68198-
Local Institution - 0008SummitNew Jersey07901-
Local Institution - 0002New YorkNew York10016-
Local Institution - 0007New YorkNew York10032-
Local Institution - 0011New YorkNew York10029-
Local Institution - 0003Chapel HillNorth Carolina27599-
Local Institution - 0005ClevelandOhio44195-
Local Institution - 0036DallasTexas75390-
Local Institution - 0029HoustonTexas77030-
Local Institution - 0034HoustonTexas77030-
Local Institution - 0004SeattleWashington98104-
Local Institution - 0057SeattleWashington98105-
Local Institution - 0058SeattleWashington98109-

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