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El ensayo clínico NCT07491900 para Systemic Lupus Erthematosus (SLE), Lupus Nephritis (LN), Extra-renal Lupus (ERL) está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE) Fase I 30 Basado en biomarcadores Escalada de dosis Etiqueta abierta
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El ensayo clínico NCT07491900 está diseñado para estudiar el tratamiento de Systemic Lupus Erthematosus (SLE), Lupus Nephritis (LN), Extra-renal Lupus (ERL). Es un estudio intervencionista de Fase I. Su estado actual es: reclutando. El estudio se inició el 23 de marzo de 2026, con el objetivo de reclutar a 30 participantes. Dirigido por Hinge Bio, se espera que finalice el 24 de octubre de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 25 de marzo de 2026.
Resumen
This Phase 1, open label, dose escalation study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of HB2198, a tetravalent bispecific anti CD19/CD20 antibody, in adults with moderately to severely active systemic lupus erythematosus (SLE), including lupus nephritis and extra renal lupus. Approximately 30 participants will receive two intravenous doses of HB2198 ...Mostrar más
Descripción detallada
HB2198 is a novel tetravalent bispecific antibody engineered for enhanced B-cell depletion through dual CD19/CD20 targeting and optimized Fc mediated effector function. The study uses a modified 3+3 dose escalation design, enrolling sequential cohorts to receive HB2198 IV on Day 1 and Day 8. Safety, dose limiting toxicities, pharmacokinetics, pharmacodynamics, and immunogenicity will be assessed. Participants will un...Mostrar más
Título oficial
A Phase 1, Open Label Dose Escalating Study of HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody With Dual Fc Domains, in Patients With Moderately to Severely Active Systemic Lupus Erythematosus
Condiciones médicas
Systemic Lupus Erthematosus (SLE)Lupus Nephritis (LN)Extra-renal Lupus (ERL)Otros ID del estudio
- HB2198-001
Número del NCT
Inicio del estudio (real)
2026-03-23
Última actualización
2026-03-25
Fecha de finalización (estimada)
2028-10-24
Inscripción (prevista)
30
Tipo de estudio
Intervencionista
FASE
Fase I
Estado general
Reclutando
Objetivo principal
Tratamiento
Método de asignación
N/A
Modelo de intervención
Grupo único
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalHB2198 Drug: HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains administered via IV infusion on Day 1 and Day 8. There are 8 Planned dose levels: 0.1 mg/kg → 16 mg/kg | HB2198 HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Number of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) | Safety and tolerability will be assessed primarily by the incidence of TEAEs and SAEs. Supporting safety data (e.g., clinical laboratory values, vital signs, ECG results, physical examinations, and renal function assessments) will be reviewed descriptively to aid interpretation of tolerability but will not be reported as separate outcome measures. | Day 1, Day 8, Day 14, Day 29 |
Maximum tolerated dose (MTD) | MTD will be determined based on the incidence of dose-limiting toxicities (DLTs) according to protocol-defined criteria. Laboratory results, vital signs, ECGs, physical examinations, and renal assessments will be used to evaluate DLTs but will not be individually reported as outcome measures. | Day 1, Day 8, Day 14, Day 29 |
Number of participants experiencing dose-limiting toxicities (DLTs) | DLTs will be evaluated based on protocol-defined criteria. Supporting safety data (e.g., labs, vitals, ECGs, physical exams, renal assessments) will be used to determine DLT classification but will not be reported as separate outcome measures. | Day 1, Day 8, Day 14, Day 29 |
Recommended Phase 2 Dose (RP2D) | The RP2D will be selected using an integrated assessment of DLTs, TEAEs, and overall tolerability, based on protocol-defined safety criteria. Clinical laboratory results, vital signs, ECGs, physical examinations, and renal assessments will be used to inform dose selection but will not be individually reported. | Day 1, Day 8, Day 14, Day 29 |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
To characterize the pharmacokinetic (PK) profile of HB2198 | Concentration of HB2198 and PK parameters such as, area under the concentration versus time curve (AUC) | Multiple timepoints collected before and after infusion on dosing days (Day 1, Day 8), and during the follow-up period on Day 14, Day 29, Month 3, Month 12 |
To characterize the pharmacokinetic (PK) profile of HB2198 | Concentration of HB2198 and PK parameters such as maximum drug concentration (Cmax) | Multiple timepoints collected before and after infusion on dosing days (Day 1, Day 8), and during the follow-up period on Day 14, Day 29, Month 3, Month 12 |
To characterize the pharmacokinetic (PK) profile of HB2198 | Concentration of HB2198 and PK parameters such as time to maximum plasma concentration (tmax) | Multiple timepoints collected before and after infusion on dosing days (Day 1, Day 8), and during the follow-up period on Day 14, Day 29, Month 3, Month 12 |
To evaluate the development of anti-drug antibodies (ADAs) | Proportion of participants developing ADAs | Multiple timepoints collected before and after infusion on dosing days (Day 1, Day 8), and during the follow-up period on Day 14, Day 29, Month 3, Month 12 |
To evaluate B-cell depletion and other pharmacodynamic changes | B cell depletion dynamics (depth, duration, subsets) | Screening, Day 1, Day 8, Day 14, Day 29, Month 2, Month 3, Month 6, Month 9, Month 12/End of Study |
To evaluate change from baseline in systemic lupus disease activity | • Change from baseline in SLEDAI 2K | Screening, Day 1, Day 14, Day 29, Month 2, Month 3, Month 4, Month 6, Month 9, Month 12/End of Study |
To evaluate change from baseline in systemic lupus disease activity | • Achievement of Lupus Low Disease Activity State (LLDAS) | Screening, Day 1, Day 14, Day 29, Month 2, Month 3, Month 4, Month 6, Month 9, Month 12/End of Study |
To evaluate change from baseline in systemic lupus disease activity | • Renal response: CRR/PRR | Day 29, Month 3, Month 6, Month 9, Month 12 |
To evaluate change from baseline in systemic lupus disease activity | • Change in LupusQoL | Screening, Day 1, Day 14, Day 29, Month 2, Month 3, Month 4, Month 6, Month 9, Month 12/End of Study |
To evaluate change from baseline in systemic lupus disease activity | • Change in FACIT Fatigue scores | Screening, Day 1, Day 14, Day 29, Month 2, Month 3, Month 4, Month 6, Month 9, Month 12/End of Study |
To evaluate change from baseline in systemic lupus disease activity | • Change in Physician Global Assessment (PGA) | Screening, Day 1, Day 14, Day 29, Month 2, Month 3, Month 4, Month 6, Month 9, Month 12/End of Study |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
• Meet 2019 ACR / 2023 EULAR SLE classification criteria
- Moderate or high disease activity (SLEDAI 2K ≥6; PGA ≥1)
- LN participants: biopsy confirmed active Class III/IV ± V or Class V LN; proteinuria ≥0.8 g/g; eGFR ≥30 mL/min/1.73 m²
- ERL participants: inadequate response/intolerance to ≥1 standard SLE therapy
- Positive ANA (≥1:80) or SLE associated autoantibodies
- Required minimum lab values (lymphocytes ≥500/µL, B cells ≥25/µL, ANC ≥1000/mm³, IgG ≥600 mg/dL, etc.)
- Women of childbearing potential: negative pregnancy test; contraception required
- Voluntary informed consent
(Key) Inclusion Criteria:
- Meet 2019 ACR / 2023 EULAR SLE classification criteria
- Moderate or high disease activity (SLEDAI 2K ≥6; PGA ≥1)
- LN participants: biopsy confirmed active Class III/IV ± V or Class V LN; proteinuria ≥0.8 g/g; eGFR ≥30 mL/min/1.73 m²
- ERL participants: inadequate response/intolerance to ≥1 standard SLE therapy
- Positive ANA (≥1:80) or SLE associated autoantibodies
- Required minimum lab values (lymphocytes ≥500/µL, B cells ≥25/µL, ANC ≥1000/mm³, IgG ≥600 mg/dL, etc.)
- Women of childbearing potential: negative pregnancy test; contraception required
- Voluntary informed consent
(Key) Exclusion Criteria:
- Anti CD19 or anti CD20 therapy within 6 months
- Active CNS lupus
- Significant cardiovascular, pulmonary, hepatic, or uncontrolled systemic disease
- Active infection or recent serious infection
- Positive HBV DNA or HCV RNA; HIV infection
- Major surgery within 4 weeks
- Prior organ or stem cell transplant
- Current pregnancy or breastfeeding
- Recent IVIg or plasmapheresis (<3 months)
- Live vaccine within 30 days
- Any condition judged unsuitable by Investigator
Hinge BioContactos centrales del estudio
Contacto: Joshua Pelham, 1-415-378-4738, [email protected]
Contacto: Kristen Quigley, [email protected]
1 Centros del estudio en 1 países
Investigational site, Brisbane, Australia
Reclutando