Trials / Not Yet Recruiting
Not Yet RecruitingNCT06708845
US Zamto-cel Autoimmune Diseases
A Phase I Multicohort Trial of Zamtocabtagene Autoleucel (Zamto-Cel) in Subjects with Severe Refractory Autoimmune Diseases
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Miltenyi Biomedicine GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This is a Phase 1, multicohort, dose-finding study evaluating autologous T cells engineered to target dual CD19 and CD20 antigens in subjects with refractory autoimmune diseases following standard therapy. The investigational product, Zamto-cel, is a chimeric antigen receptor T-cell (CAR-T) therapy genetically engineered to enable subjects' T cells to express CARs on their surfaces. Eligible subjects will undergo leukapheresis for the collection of cells required for manufacturing. Prior to infusion of the fresh CAR-T product, subjects will receive a lymphodepleting regimen consisting of cyclophosphamide and fludarabine. The CAR-T cell infusion will be administered intravenously at a dose of 2.5 x 10\^6 or 1.0 x 10\^6 CAR+ cells/kg body weight, based on the dose level assigned to the cohort. The study will initially enroll 3 subjects per cohort in a staggered manner to evaluate safety. Upon confirmation of safety, the study will proceed to cohort-specific recommended Phase 2 dose (RP2D) and dose expansion phases. Subjects will be monitored for up to 1 year to assess safety, preliminary efficacy, and health-related quality of life (HRQoL). Additional long-term follow-up will be conducted under a separate long-term follow-up protocol.
Conditions
- Lupus Nephritis
- Systemic Lupus Erythematosus
- Systemic Sclerosis (SSc)
- Diffuse Cutaneous Systemic Sclerosis
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | zamtocabtagene autoleucel | chimeric antigen receptor T-cell (CAR-T) therapy |
| DRUG | Cyclophosphamide | Lymphodepleting chemotherapy |
| DRUG | Fludarabine | Lymphodepleting chemotherapy |
Timeline
- Start date
- 2025-01-01
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2024-11-27
- Last updated
- 2024-11-27
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06708845. Inclusion in this directory is not an endorsement.