Clinical trial • Not applicable • Musculoskeletal|Immunology
KYV-101 for Lupus nephritis|Systemic sclerosis|Myasthenia gravis|Rheumatoid arthritis|Stiff-person syndrome
Not applicable trial of KYV-101 for Lupus nephritis|Systemic sclerosis|Myasthenia gravis|Rheumatoid arthritis|Stiff-person syndrome.
Overview
- Trial Therapeutic Area
- Musculoskeletal|Immunology
- Trial Disease
- Lupus nephritis|Systemic sclerosis|Myasthenia gravis|Rheumatoid arthritis|Stiff-person syndrome
- Trial Stage
- Not applicable
- Drug Modality
- Cell therapy
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 28-11-2025
- First CTIS Authorization Date
- 06-03-2026
Trial design
None/Not specified-controlled Not applicable trial across 1 site in Germany.
- Comparator
- None/Not specified
- Target Sample Size
- 100
- Trial Duration For Participant
- 5475
Eligibility
Recruits 100 Vulnerable population selected (isVulnerablePopulationSelected: true). Subject information and informed consent forms and recruitment/informed-consent procedure documents are provided (documents: L1_KYV101-004_Main_ICF_DEU_DEU_Public; L1_KYV101-004_Optional Future Research_ICF_DEU_DEU_Public; K1_KYV-101-004_Recruitment-Informed-Consent_Procedure_DEU)..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected: true). Subject information and informed consent forms and recruitment/informed-consent procedure documents are provided (documents: L1_KYV101-004_Main_ICF_DEU_DEU_Public; L1_KYV101-004_Optional Future Research_ICF_DEU_DEU_Public; K1_KYV-101-004_Recruitment-Informed-Consent_Procedure_DEU).
Inclusion criteria
- {"criterion_text":"- Received at least 1 infusion of KYV-101 as part of a previous KYV-101 parent treatment protocol"}
Exclusion criteria
- {"criterion_text":"- Not Applicable"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence of AEs, including the following: - New malignancy (ies) - New incidence or exacerbation of a pre-existing neurologic disorder - New incidence or exarcebation of a prior rheumatologic or other autoimmune disorder - New incidence of a hematologic disorder - New incidence of injection (potentially product-related) - Persistence of KYV-01 as assesse by ddPCR - Incidence of RCL by qPCR","definition_or_measurement_approach":"Incidence of adverse events recorded; includes specific events listed. Persistence of KYV-01 assessed by ddPCR. Incidence of replication competent lentivirus (RCL) assessed by qPCR."}
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 202
- Consent Approach
- Informed consent required; subject information and informed consent forms available (L1_KYV101-004_Main_ICF_DEU_DEU_Public and L1_KYV101-004_Optional Future Research_ICF_DEU_DEU_Public). A recruitment/informed-consent procedure document is available for Germany (K1_KYV-101-004_Recruitment-Informed-Consent_Procedure_DEU). Contact for sponsor medical queries: Medical Kyverna (ClinicalTrials@kyvernatx.com).
Methods
- All participants who received at least 1 infusion of KYV-101 while participating in a previous KYV-101 treatment clinical study will be asked to participate in this LTFU protocol upon completion or early discontinuation from the prior parent treatment protocol.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 30
Germany
- Earliest CTIS Part Ii Submission Date
- 11-02-2026
- Latest Decision Or Authorization Date
- 06-03-2026
- Processing Time Days
- 23
- Number Of Sites
- 1
- Number Of Participants
- 30
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Klinik für Rheumatologie, Studienabteilung
- Contact Person Name
- David Simon
- Contact Person Email
- david.simon@charite.de
- Number Of Participants
- 30
Sponsor
Primary sponsor
- Full Name
- Kyverna Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon (Lr) Limited
- Responsibilities
- Sponsor duties: TBNK (code 15); code 4. Contact: jennifer.putnam@iconplc.com
- Name
- PPD Development LP
- Responsibilities
- Sponsor duties codes: 1,10,11,12,2,3,5,6,7,8,9. Contact: CRGEUCTRInquiry.sm@thermofisher.com
- Name
- Pharmaceutical Research Associates Group B.V.
- Responsibilities
- Sponsor duties: ADA (code 15); code 4. Contact: jennifer.putnam@iconplc.com
Third parties
- {"country":"Ireland","full_name":"Icon (Lr) Limited","duties_or_roles":"TBNK (code 15); code 4","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"codes 1,10,11,12,2,3,5,6,7,8,9","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Precision For Medicine Inc.","duties_or_roles":"CAR transgene (code 15); code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Subject Travel and Subject Reimbursement (code 15)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Pharmaceutical Research Associates Group B.V.","duties_or_roles":"ADA (code 15); code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Molecularmd Corp.","duties_or_roles":"RCL (code 15); code 4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- KYV-101
- Active Substance
- KYV-101
- Modality
- Cell therapy
- Routes Of Administration
- Infusion
- Route
- INFUSION
- Authorisation Status
- Authorised
- Orphan Designation
- Yes
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