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MB-HUCART19.1

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.

Table of Contents

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.[1]

This study is authorised and is listed as an interventional trial, meaning researchers are giving the study treatment and measuring the results in participants.[1]

Who is being studied

The trial is for people with B-cell precursor ALL and B-cell Non Hodgkin Lymphoma.[1]

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.[1]

Study design and phase

This trial is a Phase 1 study with an enrollment target of 18 people.[1]

Phase 1 trials are early studies that mainly focus on safety and help researchers choose a dose for later testing.[1]

The study uses intravenous infusion, which means the treatment is given through a vein.[1]

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.[1]

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.[1]

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.[1]

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.[1]

The study is small, with only 18 planned participants, which is common in early safety research.[1]

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.[1]

Trial ID Phase Condition studied Status Enrollment
NCT07020260 Phase 1 B-cell precursor ALL; B-cell Non Hodgkin Lymphoma Authorised 18

FAQ

  • What is being studied in the MB-HUCART19.1 trial? The trial is studying MB-HUCART19.1 as a treatment given by intravenous infusion. It is designed to see how safe it is and to find the dose for the next phase of research.
  • Who can take part in this trial? The trial is for people with B-cell precursor ALL or B-cell Non Hodgkin Lymphoma. These are blood cancers that affect B cells, a type of white blood cell.
  • What phase is the MB-HUCART19.1 trial? This is a phase 1 study. Phase 1 trials mainly check safety and help find the right dose for future studies.
  • What is the main goal of the study? The main goal is to find the dose at which very few people have a dose limiting toxicity within 28 days after infusion. Dose limiting toxicity means a side effect that is serious enough to limit further dose testing.
  • How many people are planned for the study? The study plans to enroll 18 people. This is a small early-stage trial.

Ongoing Clinical Trials on MB-HUCART19.1

  • A Study Testing the Safety of CD19-Targeted CAR T-Cell Therapy in Children and Young Adults with Relapsed or Refractory B-Cell Cancers

    Not yet recruiting

    1 1
    Investigated drugs:
    The Netherlands

Glossary

  • B-cell precursor ALL: A type of blood cancer that starts in early B cells, which are cells that normally help fight infection.
  • B-cell Non Hodgkin Lymphoma: A group of cancers that begin in B cells and affect the lymph system, which is part of the immune system.
  • Interventional study: A study where researchers give a treatment or procedure and then measure the results.
  • Phase 1: The first stage of testing in people. It usually focuses on safety and finding a suitable dose.
  • Intravenous infusion: A treatment given through a vein, usually by a drip.
  • Dose limiting toxicity: A side effect that is severe enough to stop a higher dose from being tested.
  • Recommended phase 2 dose: The dose chosen from early testing to use in the next phase of research.
  • Enrollment: The number of people planned to join a study.
  • Authorised: The study has been approved to start.
  • CAR T-cell therapy: A treatment made from modified immune cells. In this trial, the name appears in the study title, but the article focuses on the trial itself.

References