US Zamto-cel Autoimmune Diseases
NCT06708845 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2024-11-27
Summary
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.
Conditions
- Lupus Nephritis
- Systemic Lupus Erythematosus
- Systemic Sclerosis (SSc)
- Diffuse Cutaneous Systemic Sclerosis
Interventions
- BIOLOGICAL
-
zamtocabtagene autoleucel
chimeric antigen receptor T-cell (CAR-T) therapy
- DRUG
-
Lymphodepleting chemotherapy
- DRUG
-
Lymphodepleting chemotherapy
Sponsors & Collaborators
-
Miltenyi Biomedicine GmbH
lead INDUSTRY
Principal Investigators
-
Esther Eromosele, MD · Miltenyi Biomedicine
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-31
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
- FDA Drug
- Yes
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