Table of Contents
- Trial overview
- Who is being studied
- Treatment plan being tested
- Trial phase and status
- What the trial measures
- What this means for patients
Trial overview
The available study is an interventional trial, which means researchers are giving a treatment plan and then measuring the results.[1] It is focused on ALLOGENEIC PERIPHERAL BLOOD-DERIVED NK CELLS CD3- CD56+ as part of a combined approach for high-risk neuroblastoma.[1]
The trial is authorised and has a planned enrollment of 19 participants.[1] The study title shows that the treatment is being used after haploidentical stem cell transplantation, followed by immunotherapy.[1]
Who is being studied
This trial is for patients with high-risk neuroblastoma that has relapsed or is progressing after first-line treatment.[1] Relapsed means the cancer came back, and progressive means it is getting worse despite treatment.
The brief summary also says the study is for patients with high-risk neuroblastoma that has relapsed or progressed after first-line treatment.[1] This makes the target group very specific: patients who still need more treatment after the first major treatment plan has not worked well enough.[1]
Treatment plan being tested
The study evaluates a treatment strategy that includes haploidentical stem cell transplantation with alfa-beta-CD19+ depletion, donor-NK cell infusion, and anti-GD2 monoclonal antibody immunotherapy.[1] A haploidentical transplant uses a half-matched donor, often a family member, and depletion means certain cells are removed before the transplant is given.
ALLOGENEIC PERIPHERAL BLOOD-DERIVED NK CELLS CD3- CD56+ are given by intravenous use in this study.[1] The trial also lists several other study drugs used in the treatment plan, including conditioning medicines before transplant and supportive treatment around the transplant process.[1]
The study does not test ALLOGENEIC PERIPHERAL BLOOD-DERIVED NK CELLS CD3- CD56+ alone.[1] Instead, it is part of a combined treatment program designed to see whether this full approach can improve results in a difficult cancer setting.[1]
Trial phase and status
This is a Phase 2 trial.[1] Phase 2 studies usually look at both safety and how well a treatment may work in a defined group of patients.
The trial status is Authorised.[1] This means the study has been approved to move forward according to the source data.[1]
What the trial measures
The main outcome listed is Overall Survival (OS).[1] Overall survival means how long patients live after the treatment begins, and it is one of the most important ways to judge cancer treatment results.
The brief summary says the study aims to evaluate the safety and efficacy of the full treatment plan.[1] Efficacy means how well the treatment works against the disease.[1]
What this means for patients
For patients, this trial is testing a complex cancer treatment plan in a small group of people with a hard-to-treat disease.[1] The goal is not only to see whether the plan can be given safely, but also whether it may help patients live longer.[1]
Because the study is limited to relapsed or progressive high-risk neuroblastoma, it is aimed at patients whose disease has already shown a poor response to earlier treatment.[1] The trial uses ALLOGENEIC PERIPHERAL BLOOD-DERIVED NK CELLS CD3- CD56+ as one part of a broader transplant-and-immunotherapy strategy.[1]
