MEN1703 (SEL24) to Treat Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01)
NCT Number: NCT06534437
Acronym: JASPIS-01
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-Hodgkin Lymphoma, B-cell
Interventions: DRUG: MEN1703|DRUG: Glofitamab
Sponsor: Ryvu Therapeutics SA
Collaborators: Menarini Group
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 178
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11
Completion Date: 2026-12
Locations: Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej, Biała Podlaska, Poland|Szpitale Pomorskie Sp. z o.o., Gdynia, Poland|Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie, Państwowy Instytut Badawczy, Gliwice, Poland|Pratia Hematologia Sp. z o.o., Katowice, Poland|Pratia MCM Kraków, Kraków, Poland|Uniwersytecki Szpital Kliniczny nr 1 w Lublinie, Lublin, Poland|Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie, Olsztyn, Poland|Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Toruń, Poland|Lux Med Onkologia Sp. z o.o., Warsaw, Poland|Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy, Warsaw, Poland

Summary:
The goal of the study is to assess the safety and anti-lymphoma activity of MEN1703 when given as a single-agent or combined with glofitamab to patients with relapsed/refractory (R/R) aggressive B-cell non-Hodgkin lymphoma. The study will be open to groups at the same time:

* Group 1 - patients who have not had anti-CD3xCD20 bispecific antibody therapy but who have had at least 2 prior lines of systemic treatment for aggressive B-cell non-Hodgkin lymphoma
* Group 2 - patients who have exhausted all standard treatment options including at least 2 prior lines of systemic treatment for aggressive B-cell non-Hodgkin lymphoma Group 1 patients will be treated for a maximum of 12 cycles. One cycle is 21 days. Group 2 with be treated until the disease progresses, therefore treatment duration is dependent on the number of treatment cycles a participant receives prior to progression.

Primary Outcome Measures: Part 1: Incidence and severity of adverse events (AE), Assessed as the number and grade of adverse events assessed by CTCAE v5.0, 12 months|Part 2 and Part 3: Complete response (CR) (group 1), Assessed per Lugano Response Criteria for Malignant Lymphoma, 12 months|Part 2 and Part 3: Overall response rate (group 2), Assessed as the number of patients who achieve a complete response (CR) or partial response (PR), per Lugano Response Criteria, divided by the total number of evaluable patients, 12 months
Secondary Outcome Measures: Part 2 and Part 3, Incidence and severity of AE, Assessed as the number and grade of adverse events assessed by CTCAE v5.0, 12 months|Maximum Plasma Concentration (Cmax), Assessment of the peak plasma concentration (Cmax), 12 months|Maximum Plasma Concentration (Tmax), Assessment of the time to peak plasma concentration (Tmax), 12 months|Area Under the Concentration Time-Curve (AUC), Assessed of the area under the plasma concentration versus time curve (AUC), 12 months|Impact of treatment on patient reported outcomes (PRO), Assessed as changes in lymphoma symptoms, well-being, and general health status measured according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) consisting of 30 questions that assess five domains of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), global health status/quality of life (GHS/QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All are scored from 0 to 100, with higher scores on the five domains and GHS/QoL being reflective of better health related (HR) QoL, and higher scores on the symptom scales and single items reflective of poor HRQoL., 12 months|Impact of treatment on quality of life (QOL), Assessed as changes in lymphoma symptoms and health related quality of life (HRQoL) as measured using the 15-item Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) including physical, social/family, emotional, and functional well-being and includes a lymphoma-specific subscale. The scale range is 0 to 60, with a higher score reflecting a better HRQoL., 12 months|Overall survival (OS), Assessed as the time from first treatment to death., 12 months|Progression-free survival (PFS), Assessed as time from the time from first treatment to the first occurrence of disease progression or death., 12 months|Duration of Response (DoR), Assessed as the time from first response (CR or PR) to the first occurrence of disease progression or death., 12 months|Duration of Complete Response (DoCR), Assessed as the time from first complete response (CR) to the first occurrence of disease progression or death., 12 months|Time to response, Assessed as the time from the first treatment to the time of first response (CR or PR)., 12 months|Time to next treatment, Assessed as the time from the first treatment to the start date of the first therapy received after the participant has ended study treatment and received subsequent anti-lymphoma therapy., 12 months