US Zamto-cel Autoimmune Diseases

ConditionsLupus Nephritis Systemic Lupus Erythematosus Systemic Sclerosis (SSc)Diffuse Cutaneous Systemic Sclerosis

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorMiltenyi Biomedicine GmbH

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

Prior gene therapy treatment

Active malignancy within past 5 years

Significant active fungal or bacterial infection

History or presence of CNS lupus or other CNS disease

Trial design

Treatments tested in this trial

zamtocabtagene autoleucel
Cyclophosphamide
Fludarabine

Treatment groups

48 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Miltenyi Biomedicine GmbH

Lead sponsor

Source ClinicalTrials.gov