US Zamto-cel Autoimmune Diseases

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Miltenyi Biomedicine GmbH
Study ID
NCT06708845
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • zamtocabtagene autoleucel — BIOLOGICAL
    chimeric antigen receptor T-cell (CAR-T) therapy
  • Cyclophosphamide — DRUG
    Lymphodepleting chemotherapy
  • Fludarabine — DRUG
    Lymphodepleting chemotherapy

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 1
  • Experimental: Dose Level 2

Primary Outcome Measure

The incidence and severity of adverse events (AEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) [ Time Frame: From enrollment through study completion 12 months post zamto-cel infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert Hospital and the Medical College of WisconsinMilwaukeeWisconsin53226
Kiley Timler
[email protected]

Find similar trials in Milwaukee, WI

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Froedtert Hospital and the Medical College of Wisconsin· Milwaukee, WI

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