C-CAR168, an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cell Therapy, in Participants With Systemic Sclerosis (SSc) Refractory to Standard Therapy

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
AbelZeta Inc.
Study ID
NCT07854483
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Systemic Sclerosis
  • Systemic Sclerosis (SSc)
  • Systemic Sclerosis (Scleroderma)
  • Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria
  • Systemic Sclerosis Pulmonary
  • Systemic Sclerosis With Lung Involvement

Eligibility Criteria

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

Interventions

  • C-CAR168 — BIOLOGICAL
    Autologous anti-CD20/BCMA chimeric antigen receptor T-cell therapy administered as a single intravenous infusion

Study Details

This Phase 1b, multicenter, open-label study will evaluate the safety and efficacy of a single infusion of autologous anti-CD20/BCMA chimeric antigen receptor T cells (C-CAR168) following lymphodepleting chemotherapy in participants with refractory Systemic Sclerosis (SSc) who are not responding to standard therapy. Approximately 6-12 participants will undergo leukapheresis, lymphodepletion with fludarabine and cyclophosphamide, and infusion of C-CAR168. Participants will be followed for 24 months (2 years) to evaluate safety, CAR T-cell persistence, pharmacokinetics/pharmacodynamics, biomarkers, and preliminary efficacy results. Long-term safety follow-up for gene therapy-related events will continue for up to 15 years following CAR T-cell infusion.

Key Dates

First listed
Oct 2, 2026
Start date
Mar 31, 2027
Status verified
Oct 2026
Primary completion
Dec 31, 2028
Completion
Mar 31, 2030

Study Design

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

Arms

  • Experimental: C-CAR168
    Participants will receive: • Leukapheresis • Fludarabine • Cyclophosphamide • Single intravenous infusion of C-CAR168

Primary Outcome Measure

Incidence and severity of treatment-emergent adverse events [ Time Frame: Through Month 24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteGilbertArizona85234-

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