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Research summary · AI summary · not yet reviewedHuman studyPhase 1Trial registry
Evaluation of C-CAR168 in Human Subjects
This Phase 1b study involves patients with refractory Systemic Sclerosis receiving leukapheresis, fludarabine, cyclophosphamide, and an infusion of C-CAR168. Participants will be monitored for 24 months to assess treatment safety and potential effects.
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This plain-English summary was written by AI from a published abstract and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
Why it matters
Understanding the safety profile and effects of C-CAR168 may provide insights into new therapeutic options for difficult-to-treat conditions like Systemic Sclerosis.
What this does not prove
No results have been posted, and planned study elements are not outcomes. Thus, outcomes remain uncertain.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Not reported
- Participants / samples
- Not reported
- Randomised
- Not reported
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
Original sources
Supporting passages (9)
study phase"briefSummary": "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.
subjects"briefSummary": "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.
peer reviewedNo results are posted.
interventionParticipants will receive: • Leukapheresis • Fludarabine • Cyclophosphamide • Single intravenous infusion of C-CAR168
comparator"briefSummary": "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.
primary endpoint"measure": "Incidence and severity of treatment-emergent adverse events",
follow upParticipants will be followed for 24 months (2 years) to evaluate safety, CAR T-cell persistence, pharmacokinetics/pharmacodynamics, biomarkers, and preliminary efficacy results.
findings"description": "Participants will receive: • Leukapheresis • Fludarabine • Cyclophosphamide • Single intravenous infusion of C-CAR168",
limitationsNo results are posted. Planned enrolment and endpoints are not findings.
AI assessment, not yet reviewed by a person · version 1 · Community votes are separate from evidence review.