← Back to Search

CAR T-cell Therapy

KYV-101 for Autoimmune Diseases (CARTIMMUNE Trial)

Phase 1

Recruiting

Research Sponsored by David Porter

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Idiopathic inflammatory myopathy (including dermatomyositis, antisynthetase syndrome, immune mediated necrotizing myopathy, and polymyositis)

Diagnosis of probable or definite (>55%) idiopathic inflammatory myopathy, including dermatomyositis, anti-synthetase myopathy, immune-mediated necrotizing myopathy (including anti-HMGCoR-myopathy, anti-SRP myopathy), polymyositis, according to the 2017 ACR/EULAR Classification Criteria for idiopathic inflammatory myopathies (Lundberg, Tjarnlund et al. 2017).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months after car infusion.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the safety and effectiveness of KYV 101, a type of treatment for autoimmune diseases, in adults. They plan to enroll up to 24 participants who will receive one dose

Who is the study for?

This trial is for adults with autoimmune diseases like inflammatory myopathies, systemic sclerosis, and lupus. Participants must have specific symptoms and test results that show active disease, such as muscle enzyme levels above normal or evidence of active myositis on MRI.

What is being tested?

The study tests KYV-101, a new CAR T-cell therapy targeting B cells in autoimmune diseases. It's given once to up to 24 people who are then monitored for two years. The trial also uses Cyclophosphamide and Fludarabine before the main treatment.

What are the potential side effects?

Potential side effects may include reactions related to the immune system's response to the therapy, which could affect different organs. There might be typical chemotherapy-related side effects from Cyclophosphamide and Fludarabine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with a type of inflammatory muscle disease.

Select...

I have been diagnosed with a specific type of muscle inflammation.

Select...

I have active skin symptoms from dermatomyositis with a severity score of 6 or more.

Select...

My muscle activity score is 2 cm or more.

Select...

I have some difficulty doing my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months after car infusion.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months after car infusion.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months after car infusion. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence and severity of AEs in AAV

Incidence and severity of AEs in DCSS

Incidence and severity of AEs in IIM.

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: SLEExperimental Treatment3 Interventions

Participants with SLE-related nephritis will receive will receive lymphodepleting chemotherapy of cyclophosphamide and fludarabine prior to administration of KYV-101.

Group II: IIMExperimental Treatment3 Interventions

Participants with idiopathic inflammatory myopathy will receive will receive lymphodepleting chemotherapy of cyclophosphamide and fludarabine prior to administration of KYV-101.

Group III: DCSSExperimental Treatment3 Interventions

Participants with diffuse cutaneous systemic sclerosis will receive lymphodepleting chemotherapy of cyclophosphamide and fludarabine prior to administration of KYV-101.

Group IV: AAVExperimental Treatment3 Interventions

Participants with ANCA-associated vasculitis will receive will receive lymphodepleting chemotherapy of cyclophosphamide and fludarabine prior to administration of KYV-101.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Fludarabine

2012

Completed Phase 4

~1860