A Modular Phase II, Single-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Surovatamig (AZD0486) in Participants with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (SOUNDTRACK-B) )
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase II
PATOLOGÍA
Linfoma Hodgkin, Linfoma no Hodgkin, Mieloma Múltiple y otras gammapatías, Terapia celular y T-CARs, Trombosis y Anticoagulantes, Linfoma
CENTRO INVESTIGADOR
H. Fundación Jiménez Díaz
INVESTIGADOR PRINCIPAL
Raúl Córdoba Mascuñano
CENTRO INVESTIGADOR
H.U. Quirónsalud Madrid
INVESTIGADOR PRINCIPAL
Carmen García Chamorro
FECHA DE APERTURA
Febrero, 2025
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
1. Participant must be 18 years old and above at the time of signing the ICF.
2. ECOG performance status of 0 to 2
3. Relapsed or refractory disease after at least 2 prior lines of systemic therapy
4. Histologically confirmed diagnosis of B-NHL, based on local pathology report, as determined by WHO 2022 classification
5. FDG-avid and measurable disease
6. Adequate liver, hematological, renal and cardiac function.
The above is a summary, other inclusion criteria details may apply
2. ECOG performance status of 0 to 2
3. Relapsed or refractory disease after at least 2 prior lines of systemic therapy
4. Histologically confirmed diagnosis of B-NHL, based on local pathology report, as determined by WHO 2022 classification
5. FDG-avid and measurable disease
6. Adequate liver, hematological, renal and cardiac function.
The above is a summary, other inclusion criteria details may apply
CRITERIOS DE EXCLUSIÓN
1. Diagnosis of chronic lymphocytic leukemia, Burkitt lymphoma, or Richters transformation
2. Active CNS involvement by B-NHL.
3. Leukemic presentation of disease
4. Prior neurotoxicity/ICANS or CRS
5. History or presence of clinically relevant CNS pathology (based on investigator assessment)
6. Prior allogeneic HSCT or solid organ transplantation within 24 weeks of first planned dose of surovatamig
The above is a summary, other exclusion criteria details may apply
2. Active CNS involvement by B-NHL.
3. Leukemic presentation of disease
4. Prior neurotoxicity/ICANS or CRS
5. History or presence of clinically relevant CNS pathology (based on investigator assessment)
6. Prior allogeneic HSCT or solid organ transplantation within 24 weeks of first planned dose of surovatamig
The above is a summary, other exclusion criteria details may apply
DESCRIPCIÓN
To evaluate the efficacy of surovatamig (AZD0486) single therapy administered at the Recommended Phase 2 Dose (RP2D) in relapsed or refractory B-cell NHL
PALABRAS CLAVE
antagonistas de la vitamin k, bispecific antibody, cd19, gammapatia monoclonal, hodgkin, hodgkin lymphoma, lymphoma, monoclonal gammopathy, non-hodgkin lymphoma, vitamin k antagonist
