In short
Clinical trials are investigating MB-HUCART19.1 in people with certain blood cancers, including B-cell precursor ALL and B-cell Non Hodgkin Lymphoma. The study is looking at safety and the dose to use for later testing. It is an interventional phase 1 trial in a small group of patients.
Key points
- MB-HUCART19.1 is being studied in a small early-stage clinical trial for people with B-cell precursor ALL and B-cell Non Hodgkin Lymphoma. The trial is a phase 1 interventional study and plans to enroll 18 people. Researchers are mainly looking at safety and the dose that causes no more than one dose limiting toxicity within 28 days after infusion. The study also aims to identify the recommended phase 2 dose. The available trial data show that MB-HUCART19.1 is being tested as an intravenous infusion in this patient group.
Trial overview
The available trial data describe MB-HUCART19.1 in the PACMAN-Hu19 trial, which is titled as a phase I/II study with locally produced CD19-targeted CAR T-cell therapy.
This study is authorised and is listed as an interventional trial, meaning researchers are giving the study treatment and measuring the results in participants.
Who is being studied
The trial is for people with B-cell precursor ALL and B-cell Non Hodgkin Lymphoma.
B-cell precursor ALL is a blood cancer that starts in early B cells, and B-cell Non Hodgkin Lymphoma is a group of cancers that begin in B cells and affect the lymph system.
Study design and phase
This trial is a Phase 1 study with an enrollment target of 18 people.
Phase 1 trials are early studies that mainly focus on safety and help researchers choose a dose for later testing.
The study uses intravenous infusion, which means the treatment is given through a vein.
What the study measures
The main outcome is the dose at which one or fewer patients have a dose limiting toxicity within 28 days after CAR T-cell infusion.
A dose limiting toxicity is a side effect serious enough to limit further dose testing, and the study uses this result to help choose the recommended phase 2 dose.
The brief summary says the study aims to determine the incidence of dose limiting toxicity within 28 days after infusion so that the recommended phase 2 dose can be selected.
What participation means
Based on the trial record, participation means joining an early study of MB-HUCART19.1 for a specific group of blood cancers and receiving the treatment by intravenous infusion.
The study is small, with only 18 planned participants, which is common in early safety research.
The available data do not provide more details about exact entry rules, so the main confirmed eligibility information is the cancer type listed in the trial record.