Last reviewed · How we verify
A Phase I Multicohort Trial of Zamtocabtagene Autoleucel (Zamto-Cel) in Subjects with Severe Refractory Autoimmune Diseases
AID is a phase I multi-cohort study to assess the safety and tolerability of zamtocabtagene autoleucel (zamto-cel) in patients with refractory autoimmune diseases (SLE-Non renal, SLE-LN, SSc/dcSSc) after receiving standard therapy.
Details
| Lead sponsor | Miltenyi Biomedicine GmbH |
|---|---|
| Phase | Phase 1 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 48 |
| Start date | 2025-01 |
| Completion | 2026-12 |
Conditions
- Lupus Nephritis
- Systemic Lupus Erythematosus
- Systemic Sclerosis (SSc)
- Diffuse Cutaneous Systemic Sclerosis
Interventions
- zamtocabtagene autoleucel
- Cyclophosphamide
- Fludarabine
Primary outcomes
- The incidence and severity of adverse events (AEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) — From enrollment through study completion 12 months post zamto-cel infusion
- The proportion of subjects with dose-limiting toxicities (DLTs) up to Day 28 and determination of recommended Phase 2 dose (RP2D) — From enrollment through Day 28 post zamto-cel infusion