Table of Contents
- Trial overview
- Who can join the study
- What the researchers are measuring
- Trial phase and study design
- Trial status and size
Trial overview
This study is investigating LUMC-BOB1-B7-TCR.1 in patients with relapsed or refractory B-cell malignancies, which means B-cell cancers that came back after treatment or did not respond well to treatment.[1]
The trial includes people with B-cell acute lymphoblastic leukemia, multiple myeloma, and non-Hodgkin B-cell lymphoma.[1]
The main goal is to learn whether the treatment can be made and given as planned, and whether it is safe and may help patients respond.[1]
Who can join the study
The study is for patients who are HLA-B*07:02 positive.[1]
HLA-B*07:02 is a specific marker on cells, and the trial only includes people with this marker.[1]
People in the study must also have one of the target B-cell cancers listed in the trial record.[1]
What the researchers are measuring
In Phase 1, researchers are checking whether a drug product can be manufactured at the intended dose and whether included patients actually receive treatment.[1]
They are also measuring dose-limiting toxicities, which are side effects serious enough to limit further dose increases, during the 28 days after infusion.[1]
Another Phase 1 goal is to find the maximum tolerated dose, meaning the highest dose that still has acceptable safety, and then choose a recommended dose for Phase 2.[1]
In Phase 2, the study measures safety and toxicity by looking at serious and other adverse events for up to 2 years after infusion, using ASTCT and CTCAE reporting standards.[1]
The trial also measures response rate at 12 weeks after infusion, with response defined as absence of circulating B cells and/or the best objective response described in the literature.[1]
Trial phase and study design
This is an interventional study, which means the researchers assign a treatment and then watch what happens.[1]
The trial is a Phase 1/2 study, so it combines early dose-finding work with a later look at safety and response.[1]
The phase 1 dose work uses a Bayesian Dose Interval (BOIN) design, a method that helps researchers adjust dose levels based on observed toxicity rates.[1]
The target toxicity rate in this design is 0.3, which means the study is trying to find a dose level with an acceptable level of serious side effects.[1]
Trial status and size
The trial is currently Authorised.[1]
The planned enrollment is 22 patients.[1]
The intervention is given by intravenous administration, which means through a vein.[1]
