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CAR T-cell Therapy

CD19 CAR T-Cell Therapy for Scleroderma

Phase 1 & 2
Recruiting
Research Sponsored by Kyverna Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical diagnosis of SSc according to 2013 ACR/EULAR classification
Be older than 18 years old
Must not have
Clinically significant ILD
Prior treatment with cellular therapy (CAR-T) or gene therapy product directed at any target
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new therapy using modified immune cells to treat people with systemic sclerosis.

Who is the study for?
This trial is for people with a condition called systemic sclerosis, specifically the diffuse cutaneous type. They should be within 6 years of their first symptom that's not Raynaud's phenomenon and have active disease. Participants must also be current on vaccinations recommended for those with weakened immune systems.
What is being tested?
The study is testing KYV-101, which is a type of CAR T-cell therapy targeting CD19, an antigen found on certain cells in the body. This therapy will be compared to or combined with standard treatments that reduce the number of lymphocytes (a type of white blood cell).
What are the potential side effects?
CAR T-cell therapies like KYV-101 can cause side effects such as fever, fatigue, headache, difficulty breathing, low blood pressure, and may affect normal blood cells leading to increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with systemic sclerosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a serious lung condition.
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I have previously received CAR-T or gene therapy.
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I have had a stem cell transplant.
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I have had my spleen removed.
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I have heart problems that affect my daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To evaluate efficacy of KYV-101(Phase 2)
Secondary study objectives
To evaluate efficacy of KYV-101 (Phase 1 and Phase 2)
To evaluate immunogenicity (humoral response) of KYV-101 (Phase 1 and Phase 2)
To evaluate pharmacodynamics (PD) of KYV-101 in blood (Phase 1 and Phase 2)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 2)Experimental Treatment2 Interventions
Recommended Phase 2 Dose
Group II: KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 1)Experimental Treatment2 Interventions
Dosing with KYV-101 CAR T cells

Find a Location

Who is running the clinical trial?

Kyverna TherapeuticsLead Sponsor
10 Previous Clinical Trials
296 Total Patients Enrolled
MDStudy DirectorKyverna Therapeutics, Inc.
972 Previous Clinical Trials
939,987 Total Patients Enrolled
~14 spots leftby Mar 2026
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