Active — Not RecruitingPhase 1

CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101

United States24 participantsStarted 2024-08-05

Plain-language summary

The purpose of this study is to assess the safety, tolerability, and clinical activity of KYV 101 (a fully-human anti-CD19 CAR T-cell therapy) in adult subjects with B cell-driven autoimmune diseases. The trial anticipates enrolling participants to reach a maximum of 24 participants who will receive 1 dose of KYV-101 and will be followed for 2 years.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).
. Disease severity and minimal core set measure criteria: MMT-8 score \<136/150, with at least 2 other abnormal core set measures (CSMs) from the following:
. Active disease as per one of the following:
. Positive, at screening or by documented medical history, for one myositis-specific per pre specified list (Table 3), except for patients with DM who need not have a positive test for a myositis-specific antibody.
. Refractory disease: subject with previous failure (or intolerance) to glucocorticoids and at least two non-glucocorticoids immunosuppressive therapies. An adequate trial of medication defined as at least 12 weeks of therapy or intolerance/adverse reaction necessitating discontinuation.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence and severity of AEs in IIM.

Timeframe: 3 months after CAR infusion.

Incidence and severity of AEs in IIM.

Timeframe: 6 months after CAR infusion.

Incidence and severity of AEs in IIM.

Timeframe: 12 months after CAR infusion.

Incidence and severity of AEs in IIM.

Timeframe: 24 months after CAR infusion.

Incidence and severity of AEs in DCSS

Timeframe: 3 months after CAR infusion.

Incidence and severity of AEs in DCSS

Timeframe: 6 months after CAR infusion.

Incidence and severity of AEs in DCSS

Timeframe: 12 months after CAR infusion.

Trial details

NCT IDNCT06152172

SponsorDavid Porter

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02

View on ClinicalTrials.gov More Idiopathic Inflammatory Myopathies trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).
. Disease severity and minimal core set measure criteria: MMT-8 score \<136/150, with at least 2 other abnormal core set measures (CSMs) from the following:
. Active disease as per one of the following:
. Positive, at screening or by documented medical history, for one myositis-specific per pre specified list (Table 3), except for patients with DM who need not have a positive test for a myositis-specific antibody.
. Refractory disease: subject with previous failure (or intolerance) to glucocorticoids and at least two non-glucocorticoids immunosuppressive therapies. An adequate trial of medication defined as at least 12 weeks of therapy or intolerance/adverse reaction necessitating discontinuation.

What they're measuring

Incidence and severity of AEs in IIM.

Timeframe: 3 months after CAR infusion.

Incidence and severity of AEs in IIM.

Timeframe: 6 months after CAR infusion.

Incidence and severity of AEs in IIM.

Timeframe: 12 months after CAR infusion.

Incidence and severity of AEs in IIM.

Timeframe: 24 months after CAR infusion.

Incidence and severity of AEs in DCSS

Timeframe: 3 months after CAR infusion.

Incidence and severity of AEs in DCSS

Timeframe: 6 months after CAR infusion.

Incidence and severity of AEs in DCSS

Timeframe: 12 months after CAR infusion.

CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria