In short
Clinical trials are investigating MB-CART2219.1 in people with relapsed or refractory B-cell cancers. The study is looking at feasibility, safety, and early signs of benefit in adult and pediatric patients, including children aged 3 years and older. It focuses on CD19 and/or CD22 positive lymphoma or ALL.
Key points
- MB-CART2219.1 is being studied in a Phase 1 clinical trial for people with relapsed or refractory B-cell cancers. The trial includes both adults and children aged 3 years and older. It focuses on lymphoma and acute lymphoblastic leukemia (ALL) when the cancer cells are CD19 and/or CD22 positive. The main goals are to assess feasibility, safety, and early signs of benefit. The study plans to enroll 36 participants and is currently authorised.
Trial overview
This study is an interventional trial, which means participants receive a study treatment and researchers measure the results. The trial is authorised and plans to include 36 people. The treatment being studied is MB-CART2219.1, given by intravenous infusion.
Who can participate
The trial is for adult and pediatric patients with relapsed or refractory B-cell malignancies. The listed conditions include lymphoma or ALL in patients aged 3 years and older. In simple terms, this means the cancer has come back after treatment or has not responded well to treatment.
Study phase and design
This is a Phase 1 study, which is an early trial stage. Phase 1 trials mainly look at safety and help researchers learn whether the study can be done as planned. The title also says this is a dose finding study, meaning the researchers are working to understand the right dose range for the trial.
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. Feasibility means whether the study can be carried out successfully. Preliminary efficacy means early signs that the treatment may help.
The brief summary repeats that the trial is focused on feasibility and safety in this patient group. Because this is an early study, the results are meant to give first information rather than final proof of benefit.
Conditions and target patients
The trial focuses on relapsed/refractory lymphoma and ALL in people whose cancer cells are CD19 and/or CD22 positive. Lymphoma is a cancer of the lymphatic system, and ALL is acute lymphoblastic leukemia, a fast-growing blood cancer. The target group includes both adults and children, starting at age 3 years.
Key patient terms
- Relapsed means the cancer came back after treatment.
- Refractory means the cancer did not respond well to treatment.
- CD19 positive and CD22 positive mean the cancer cells carry certain markers on their surface.
- Intravenous infusion means the treatment is given through a vein.