In short
Clinical trials are studying MAPLIRPACEPT in adults with relapsed or refractory diffuse large B cell lymphoma. The research is looking at safety, dose-limiting toxicities, and anti-tumor activity when MAPLIRPACEPT is given with other study medicines. The goal is to find doses and measure how well the treatment works in this cancer group.
Key points
- Clinical trials of MAPLIRPACEPT are studying adults with relapsed or refractory diffuse large B cell lymphoma. The main trial is a Phase 1 study with Phase 1b and Phase 2 parts. Researchers are looking first at safety, dose-limiting toxicities, and dose selection, then at anti-tumor activity. The study tests MAPLIRPACEPT with glofitamab after a single dose of obinutuzumab. The trial has been completed and included 90 participants.
Trial overview
The available trial for MAPLIRPACEPT was an interventional study, which means the researchers gave study medicines and then measured the results. The study focused on adults with relapsed or refractory diffuse large B cell lymphoma, a type of blood cancer that has come back or has not responded well to earlier treatment.
This trial was designed to learn about both safety and possible anti-cancer effect when MAPLIRPACEPT was used with other study medicines. The study was completed.
Who was studied
The target group was adult participants with relapsed or refractory diffuse large B cell lymphoma. In simple terms, this means the trial was not for healthy volunteers; it was for adults living with this specific lymphoma after earlier treatment did not work well or the disease returned.
The brief summary states that the study used a single dose of obinutuzumab before the main study treatment in these adults. The data do not describe other detailed entry rules, so only the population above can be confirmed from the source.
What was tested
The trial studied MAPLIRPACEPT, also listed as PF-07901801, together with glofitamab. The intervention list also names obinutuzumab, which was given as a single dose before the study medicines in the summary.
These names come directly from the trial record, and PF-07901801 is a synonym for MAPLIRPACEPT in this study. The article does not describe how these medicines work, because the trial data focus on the research plan and outcomes rather than a drug monograph.
Trial phases and endpoints
This was a Phase 1 study, with two parts: Phase 1b and Phase 2. Phase 1b is an early part of research that mainly checks safety and helps choose doses for later testing.
In Phase 1b, the main endpoint was dose-limiting toxicities during the 21-day observation period after Cycle 1 Day 1. Dose-limiting toxicities are side effects serious enough to limit how much treatment can be given.
The Phase 1b goal was to assess safety and tolerability of PF-07901801 and glofitamab after a single dose of obinutuzumab, and then select up to two doses of PF-07901801 for Phase 2. This means the early part of the study helped researchers decide which dose levels should be tested further.
In Phase 2, the main endpoint was overall response using the Lugano Response Classification Criteria 2014, as judged by the investigator. Overall response means how much the cancer shrinks or improves after treatment.
What the study measured
The study measured safety, tolerability, and signs of anti-tumor activity. In patient language, this means the researchers checked whether the treatment could be given safely and whether there were signs that the lymphoma responded.
- Safety: whether the treatment caused harmful effects that mattered for the study.
- Tolerability: how manageable the treatment was for participants.
- Dose selection: choosing the dose levels of PF-07901801 to move forward into Phase 2.
- Anti-tumor activity: checking for signs that the lymphoma improved after treatment.
The trial also used the Lugano Response Classification Criteria 2014 to judge response in Phase 2. This is a standard method used in lymphoma research to measure treatment effect.
Status and size of the study
The study status is completed, so it is no longer enrolling participants. The enrollment was 90 participants.
Only one trial was provided in the source data, so the summary here is based on that single completed study. No other MAPLIRPACEPT trials were included in the source material.