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O estudo clínico NCT06400303 para Esclerose Sistêmica, Systemic Sclerosis - Diffuse Cutaneous, Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria está ativo, não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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KYSA-5: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Systemic Sclerosis Fase I, Fase II 3 Terapia celular

Ativo, não recrutando
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06400303 procura avaliar tratamento para Esclerose Sistêmica, Systemic Sclerosis - Diffuse Cutaneous, Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria. Este é um estudo intervencionista de Fase I Fase II. Seu status atual é: ativo, não recrutando. O estudo começou em 6 de agosto de 2024 e pretende incluir 3 participantes. Coordenado por Kyverna Therapeutics e deve ser concluído em 1 de março de 2027. Essas informações foram atualizadas no ClinicalTrials.gov em 8 de outubro de 2025.
Resumo
A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects with Systemic Sclerosis
Descrição detalhada
SSc is an immune-mediated rheumatic disease that is characterized by fibrosis of the skin and internal organs and vasculopathy. B-cells play a role in SSc, and the disease is characterized by the presence of autoantibodies such as anti-Scl-70 and anti-RNAP III antibodies. CD19-targeted chimeric antigen receptor (CAR) T-cells harness the ability of cytotoxic T-cells to directly and specifically lyse target cells to ef...Mostrar mais
Título oficial

KYSA-5: A Phase 1/2, Open-Label, Multicentre Study of KYV 101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T Cell (CD19 CAR T) Therapy, in Subjects With Systemic Sclerosis

Condições médicas
Esclerose SistêmicaSystemic Sclerosis - Diffuse CutaneousSystemic Sclerosis - 2013 ACR/EULAR Classification Criteria
Publicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:
Outros IDs do estudo
  • KYSA-5
  • KYV101-005 (Outro identificador) (Kyverna Therapeutics)
Número NCT
Data de início (real)
2024-08-06
Última atualização postada
2025-10-08
Data de conclusão (estimada)
2027-03
Inscrição (estimada)
3
Tipo de estudo
Intervencionista
FASE
Fase I
Fase II
Status
Ativo, não recrutando
Palavras-chave
KYV-101
systemic sclerosis
autoimmune disease
anti-CD19 CAR-T therapy
cellular therapy
Scleroderma
Propósito principal
Tratamento
Alocação do design
Não randomizado
Modelo de intervenção
Sequencial
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
ExperimentalKYV-101 CAR-T cells with lymphodepletion conditioning (Phase 1)
Dosing with KYV-101 CAR T cells
KYV-101
Anti-CD19 CAR-T cell therapy
Standard lymphodepletion regimen
Standard lymphodepletion regimen
ExperimentalKYV-101 CAR-T cells with lymphodepletion conditioning (Phase 2)
Recommended Phase 2 Dose
KYV-101
Anti-CD19 CAR-T cell therapy
Standard lymphodepletion regimen
Standard lymphodepletion regimen
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Incidence of adverse events and laboratory abnormalities (Phase 1)
Up to 2 years
Frequency of Dose-Limiting Toxicities (DLTs) at each dose level (Phase 1)
Up to 2 years
To evaluate efficacy of KYV-101(Phase 2)
via revised Composite Response Index in Systemic Sclerosis (rCRISS) 30/5
52 weeks
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
To evaluate pharmacodynamics (PK) of KYV-101 in blood (Phase 1 and Phase 2)
Chimeric antigen receptor-positive (CAR-positive) T-cell counts in blood
Up to 2 years
To evaluate pharmacodynamics (PD) of KYV-101 in blood (Phase 1 and Phase 2)
Levels of B-cells in blood
Up to 2 years
To evaluate pharmacodynamics (PD) of KYV-101 in blood (Phase 1 and Phase 2)
Levels of cytokines in serum
Up to 2 years
To evaluate efficacy of KYV-101 (Phase 1 and Phase 2)
revised Composite Response Index in Systemic Sclerosis (rCRISS) 30/5 response rate
12, 24, 52 weeks
To evaluate immunogenicity (humoral response) of KYV-101 (Phase 1 and Phase 2)
Percentage of participants who develop anti-KYV-101 antibodies by immunoassays
Up to 2 years
To define the Recommended Phase 2 Dose (RP2D) (Phase 1)
Up to 2 years
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
  1. Clinical diagnosis of SSc according to 2013 ACR/EULAR classification
  2. Clinical disease as follows: Classified as diffuse cutaneous SSc; ≤ 6 years since first non-Raynaud's sign or symptom; active disease
  3. Up to date on all recommended vaccinations per CDC or institutional guidelines for immune-compromised individuals

  1. Clinically significant ILD

  2. Prior treatment with cellular therapy (CAR-T) or gene therapy product directed at any target

  3. History of allogeneic or autologous stem cell transplant

  4. Evidence of active hepatitis B or hepatitis C infection

  5. Positive serology for HIV

  6. Primary immunodeficiency

  7. History of splenectomy

  8. History of stroke, seizure, dementia, Parkinson's disease, coordination movement disorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologic disorder investigator considers would increase the risk for the subject

  9. Impaired cardiac function or clinically significant cardiac disease

  10. Previous or concurrent malignancy with the following exceptions:

    1. Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to screening)
    2. In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to screening
    3. A primary malignancy which has been completely resected, or treated, and is in complete remission for at least 5 years prior to screening
Kyverna Therapeutics logoKyverna Therapeutics
Sem dados de contato.
2 Locais do estudo em 1 países

California

Stanford University Medical Center, Palo Alto, California, 94305, United States

New York

Northwell Health, Great Neck, New York, 11021, United States