Table of Contents
- Trial overview
- Who can participate
- Study phase and design
- What the trial measures
- Conditions and target patients
- Key patient terms
Trial overview
This study is an interventional trial, which means participants receive a study treatment and researchers measure the results.[1] The trial is authorised and plans to include 36 people.[1] The treatment being studied is MB-CART2219.1, given by intravenous infusion.[1]
Who can participate
The trial is for adult and pediatric patients with relapsed or refractory B-cell malignancies.[1] The listed conditions include lymphoma or ALL in patients aged 3 years and older.[1] In simple terms, this means the cancer has come back after treatment or has not responded well to treatment.[1]
Study phase and design
This is a Phase 1 study, which is an early trial stage.[1] Phase 1 trials mainly look at safety and help researchers learn whether the study can be done as planned.[1] The title also says this is a dose finding study, meaning the researchers are working to understand the right dose range for the trial.[1]
What the trial measures
The main objective is to assess feasibility, safety, and preliminary efficacy of ex vivo generated MB-CART2219.1 in patients with CD19 and/or CD22 positive B-cell malignancies.[1] Feasibility means whether the study can be carried out successfully.[1] Preliminary efficacy means early signs that the treatment may help.[1]
The brief summary repeats that the trial is focused on feasibility and safety in this patient group.[1] Because this is an early study, the results are meant to give first information rather than final proof of benefit.[1]
Conditions and target patients
The trial focuses on relapsed/refractory lymphoma and ALL in people whose cancer cells are CD19 and/or CD22 positive.[1] Lymphoma is a cancer of the lymphatic system, and ALL is acute lymphoblastic leukemia, a fast-growing blood cancer.[1] The target group includes both adults and children, starting at age 3 years.[1]
