Table of contents
- Trial overview
- Who could participate
- What was studied
- Study phases and endpoints
- Trial status and size
Trial overview
The main clinical trial in the source data was NCT05896163, a Phase 1 interventional study of MAPLIRPACEPT in adults with relapsed or refractory diffuse large B-cell lymphoma.[1] The study tested MAPLIRPACEPT together with glofitamab after a single dose of obinutuzumab.[1]
Who could participate
The trial was designed for adult participants with relapsed or refractory diffuse large B-cell lymphoma.[1] Relapsed means the cancer came back after treatment, and refractory means it did not respond well to treatment.[1]
What was studied
The study looked at MAPLIRPACEPT given in combination with glofitamab, with a single dose of obinutuzumab first.[1] The research team wanted to learn about the effects of this treatment plan in people with this type of lymphoma.[1]
The trial included two parts: Phase 1b and Phase 2.[1] In Phase 1b, the main goal was to assess dose-limiting toxicities, safety, and tolerability, and to choose up to two doses of MAPLIRPACEPT for later testing.[1] In Phase 2, the study assessed clinical anti-tumor activity, which means how well the treatment may work against the lymphoma.[1]
Study phases and endpoints
The primary endpoint in Phase 1b was dose-limiting toxicities during the 21 days after Cycle 1 Day 1.[1] This endpoint helps researchers see whether side effects are strong enough to limit the dose or stop further increase.[1]
The primary endpoint in Phase 2 was overall response based on the Lugano Response Classification Criteria 2014, as assessed by the investigator.[1] Overall response is a standard way to measure whether the cancer shrinks or disappears during treatment.[1]
Trial status and size
The study status is listed as completed.[1] The enrollment was 90 participants.[1] The study was interventional, which means the researchers gave treatment and then measured what happened.[1]
