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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 belowSelect...
I have been diagnosed with systemic sclerosis.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a serious lung condition.
Select...
I have previously received CAR-T or gene therapy.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
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 moreAwards & 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.
1,003 Previous Clinical Trials
945,219 Total Patients Enrolled