48 Participants NeededMy employer runs this trial

Zamtocabtagene Autoleucel for Lupus

SS
RG
PJ
Overseen ByParis Jamiel
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Miltenyi Biomedicine GmbH
Must be taking: Glucocorticoids, Hydroxychloroquine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called zamtocabtagene autoleucel, a type of cell therapy, to determine its safety and tolerability in people with certain autoimmune diseases like lupus and systemic sclerosis. The trial includes different groups to evaluate various doses of the treatment. Prospective participants should have a confirmed diagnosis of one of these autoimmune conditions and must not have responded well to standard treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Is there any evidence suggesting that zamtocabtagene autoleucel is likely to be safe for humans?

Research has shown that zamtocabtagene autoleucel, or zamto-cel, is being tested for safety in people with autoimmune diseases like lupus. As this is an early study, detailed safety information remains unavailable. However, similar treatments have been well-tolerated in other research. Early studies of related therapies have shown promising safety results, with most patients experiencing only mild side effects. This study will continue to monitor for any unwanted effects, a common practice to ensure participant safety.12345

Why do researchers think this study treatment might be promising for lupus?

Unlike the standard lupus treatments that typically involve immunosuppressants and anti-inflammatory drugs, zamtocabtagene autoleucel is a cutting-edge therapy that uses CAR-T cell technology. This approach involves reprogramming a patient’s own T-cells to specifically target and destroy malfunctioning immune cells causing the lupus symptoms. Researchers are excited about zamtocabtagene autoleucel because it has the potential to offer a more precise, long-lasting solution with fewer side effects compared to traditional therapies. By addressing the underlying immune dysfunction in lupus with targeted action, this treatment represents a significant advancement in personalized medicine for autoimmune diseases.

What evidence suggests that zamtocabtagene autoleucel might be an effective treatment for lupus?

Research has shown that zamtocabtagene autoleucel, a type of CAR T-cell therapy, may help treat autoimmune diseases like lupus. Early findings suggest this treatment could enable patients to stop taking regular medication to control their symptoms. Initial data indicate that the treatment reduces B-cell levels, often linked to lupus activity. Furthermore, early studies have demonstrated that zamtocabtagene autoleucel is safe and initially effective for people with systemic lupus erythematosus (SLE). While more research is needed, these early results are promising. Participants in this trial will receive different dose levels of zamtocabtagene autoleucel to evaluate its safety and effectiveness.15678

Who Is on the Research Team?

EE

Esther Eromosele, MD

Principal Investigator

Miltenyi Biomedicine

Are You a Good Fit for This Trial?

This trial is for people with severe autoimmune diseases like lupus or scleroderma that haven't improved with standard treatments. Participants must be adults and generally healthy enough to undergo treatment, but specific inclusion/exclusion details are determined by the study team.

Inclusion Criteria

General Key Inclusion/

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Leukapheresis

Eligible subjects undergo leukapheresis for the collection of cells required for manufacturing

1 week

Lymphodepletion

Subjects receive a lymphodepleting regimen consisting of cyclophosphamide and fludarabine prior to CAR-T infusion

1 week

Treatment

CAR-T cell infusion administered intravenously at a dose of 2.5 x 10^6 or 1.0 x 10^6 CAR+ cells/kg body weight

1 day

Follow-up

Participants are monitored for safety, preliminary efficacy, and HRQoL for up to 1 year

52 weeks

Long-term follow-up

Additional long-term follow-up conducted under a separate protocol

What Are the Treatments Tested in This Trial?

Interventions

  • zamtocabtagene autoleucel

Trial Overview

The study tests a new cell therapy called zamtocabtagene autoleucel (zamto-cel) after patients receive chemotherapy drugs fludarabine and cyclophosphamide. The main goal is to see if zamto-cel is safe and tolerable in these conditions.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Dose Level 2Experimental Treatment3 Interventions
Group II: Dose Level 1Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Miltenyi Biomedicine GmbH

Lead Sponsor

Trials
38
Recruited
1,700+

Citations

Safety and clinical efficacy of Relmacabtagene autoleucel ...

We report the results from a phase I open-label clinical trial of relma-cel in treating patients with moderately to severely active SLE.

LBP1 Interim results of an open-label, multicentre, Phase 1/ ...

Interim data from this clinical trial suggest favourable safety, CAR T-cell expansion, B-cell depletion and initial efficacy of YTB323 in srSLE, supporting its ...

CAR T-cell therapy in systemic lupus erythematosus

Although the initial reports in this patient subset demonstrated promising results and long-lasting drug-free remissions, more clinical data are required to ...

(PDF) Safety and clinical efficacy of Relmacabtagene ...

This study preliminarily demonstrated that relma-cel is an effective and safe CAR-T product for the treatment of patients with moderately to severely active ...

Systemic Lupus Erythematosus 1 (SLEB1)

A Randomized Controlled Trial of a Psychoeducational Intervention to Improve Outcomes in Systemic Lupus Erythematosus (SLE), Completed, NCT00000417, Phase 2.

US Zamto-cel Autoimmune Diseases

AID is a phase I multi-cohort study to assess the safety and tolerability of zamtocabtagene autoleucel (zamto-cel) in patients with refractory ...

US Zamto-cel Autoimmune Diseases - ClinicalTrials.Veeva

AID is a phase I multi-cohort study to assess the safety and tolerability of zamtocabtagene autoleucel (zamto-cel) in patients with refractory ...

CAR T-cell therapy in systemic lupus erythematosus

Since the discovery of CARs , their structure has been continuously refined based on efficacy and safety data. zamtocabtagene autoleucel (zamto ...