A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease

Part of paid clinical trials in Redwood City, California.

Sponsor
CRISPR Therapeutics
Study ID
NCT06925542
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • CTX112 — BIOLOGICAL
    CTX112 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)

Study Details

This is a single-arm, open-label, multicenter, ascending dose Phase 1 study evaluating the safety and preliminary efficacy of CTX112 in adult subjects with refractory autoimmune diseases, including active systemic lupus erythematosus (SLE), systemic sclerosis (SSc), or idiopathic inflammatory myopathy (IIM).

Key Dates

Start date
Mar 10, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CTX112
    Administered by IV infusion following lymphodepleting chemotherapy

Primary Outcome Measure

To evaluate the safety of CTX112 in adult subjects with refractory autoimmune diseases, including SLE, SSc or IIM [ Time Frame: From CTX112 infusion up to 28 days post-infusion ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Research Site 4Redwood CityCalifornia94063-
Research Site 2ChicagoIllinois63110-
Research Site 8Iowa CityIowa52242-
Research Site 6BostonMassachusetts02118-
Research Site 1St LouisMissouri63130-
Research Site 5Chapel HillNorth Carolina27599-

Find similar trials in Redwood City, CA

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Research· Redwood City, CAResearch· Chicago, ILResearch· Iowa City, IAResearch· Boston, MAResearch· St Louis, MOResearch· Chapel Hill, NC

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