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US Zamto-cel Autoimmune Diseases

ConditionsLupus NephritisSystemic Lupus ErythematosusSystemic 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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • zamtocabtagene autoleucel

    Biological/Vaccine

    chimeric antigen receptor T-cell (CAR-T) therapy

  • Cyclophosphamide

    Drug

    Lymphodepleting chemotherapy

  • Fludarabine

    Drug

    Lymphodepleting chemotherapy

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Dose Level 1Experimental treatment 3 interventions
Group B: Dose Level 2Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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
2

The proportion of subjects with dose-limiting toxicities (DLTs) up to Day 28 and determination of recommended Phase 2 dose (RP2D)

Time frame
From enrollment through Day 28 post zamto-cel infusion

Secondary outcomes

1

The incidence and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS)

Time frame
From enrollment through study completion 12 months post zamto-cel infusion
2

Clinical response at Week 4, 12, 24, and 52 evaluated by defined disease-specific activity measures in SLE-Non renal, SLE-LN, and SSc/dcSSc

Time frame
From enrollment through study completion 12 months post zamto-cel infusion
3

The duration of remission or low disease activity status in respective diseases under the study

Time frame
From enrollment through study completion 12 months post zamto-cel infusion
4

Persistence, maximal drug concentration (Cmax), time to reach Cmax, area under the concentration curve, and phenotype of zamto-cel

Time frame
From enrollment through study completion 12 months post zamto-cel infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Miltenyi Biomedicine GmbH

Lead sponsor

Source ClinicalTrials.gov
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