IA Trial Radar | ||
|---|---|---|
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. | ||
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
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
- KYSA-5
- KYV101-005 (Outro identificador) (Kyverna Therapeutics)
Fase II
systemic sclerosis
autoimmune disease
anti-CD19 CAR-T therapy
cellular therapy
Scleroderma
| Grupo de participantes/Braço | Intervenção/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 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
- Clinical diagnosis of SSc according to 2013 ACR/EULAR classification
- Clinical disease as follows: Classified as diffuse cutaneous SSc; ≤ 6 years since first non-Raynaud's sign or symptom; active disease
- Up to date on all recommended vaccinations per CDC or institutional guidelines for immune-compromised individuals
Clinically significant ILD
Prior treatment with cellular therapy (CAR-T) or gene therapy product directed at any target
History of allogeneic or autologous stem cell transplant
Evidence of active hepatitis B or hepatitis C infection
Positive serology for HIV
Primary immunodeficiency
History of splenectomy
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
Impaired cardiac function or clinically significant cardiac disease
Previous or concurrent malignancy with the following exceptions:
- Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to screening)
- In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to screening
- A primary malignancy which has been completely resected, or treated, and is in complete remission for at least 5 years prior to screening
California
New York