In short
Clinical trials are investigating LUMC-BOB1-B7-TCR.1 in people with relapsed or refractory B-cell cancers. These studies aim to check whether treatment can be made, given safely, and help patients respond. The main target group includes HLA-B*07:02-positive patients with B-cell acute lymphoblastic leukemia, multiple myeloma, or non-Hodgkin B-cell lymphoma.
Key points
- LUMC-BOB1-B7-TCR.1 is being studied in a Phase 1/2 clinical trial for relapsed or refractory B-cell cancers. The target conditions are B-cell acute lymphoblastic leukemia, multiple myeloma, and non-Hodgkin B-cell lymphoma. The trial is limited to patients who are HLA-B*07:02 positive. Researchers are checking whether the treatment can be manufactured and given as planned, and whether it is safe and effective. Main measures include dose-limiting toxicities, the maximum tolerated dose, the recommended dose for Phase 2, safety up to 2 years, and response at 12 weeks.
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.
The trial includes people with B-cell acute lymphoblastic leukemia, multiple myeloma, and non-Hodgkin B-cell lymphoma.
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.
Who can join the study
The study is for patients who are HLA-B*07:02 positive.
HLA-B*07:02 is a specific marker on cells, and the trial only includes people with this marker.
People in the study must also have one of the target B-cell cancers listed in the trial record.
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.
They are also measuring dose-limiting toxicities, which are side effects serious enough to limit further dose increases, during the 28 days after infusion.
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.
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.
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.
Trial phase and study design
This is an interventional study, which means the researchers assign a treatment and then watch what happens.
The trial is a Phase 1/2 study, so it combines early dose-finding work with a later look at safety and response.
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.
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.
Trial status and size
The trial is currently Authorised.
The planned enrollment is 22 patients.
The intervention is given by intravenous administration, which means through a vein.