Table of contents
- Trial overview
- Who the study is for
- Study phase and design
- What the trial measures
- Treatments used in the study
- What the trial details mean for patients
Trial overview
The available trial is an interventional study, which means people receive a treatment that is being tested.[1] It is studying HSP-CAR19M in adults with B-cell non-Hodgkin lymphoma.[1]
The study is authorised and plans to enroll 40 participants.[1]
Who the study is for
The trial is for adults with relapsed/refractory large B-cell non-Hodgkin lymphoma, mantle cell lymphoma, and follicular lymphoma.[1] Relapsed means the cancer came back after treatment, and refractory means it did not respond well to treatment.[1]
These conditions are all types of B-cell non-Hodgkin lymphoma, which are cancers that start in B cells, a kind of white blood cell.[1]
Study phase and design
This is a Phase 1/2 trial.[1] Phase 1/2 studies first look closely at safety, then also look for early signs that the treatment may help.[1]
The brief summary says the study is evaluating the safety, toxicity, and efficacy of autologous memory T cells that are expanded outside the body and genetically modified with a chimeric antigen receptor targeting CD19.[1] In simple terms, the trial is testing a personalized cell therapy made from the patient’s own cells.[1]
What the trial measures
The primary outcome is safety associated with infusion of HSP-CAR19M cells.[1] Safety outcomes help researchers see whether the treatment can be given without causing unacceptable problems.[1]
In the expansion phase, the study also evaluates safety and efficacy of HSP-CAR19M cell administration.[1] Efficacy means how well the treatment works against the cancer.[1]
Treatments used in the study
The intervention list includes HSP-CAR19M and several other drugs given by intravenous infusion.[1] The trial data do not explain the full role of each listed drug, so the key point is that HSP-CAR19M is part of a treatment plan studied in this trial.[1]
Intravenous infusion means a treatment is given through a vein, usually over time.[1]
What the trial details mean for patients
For patients, this study is an early-stage attempt to learn whether HSP-CAR19M can be used safely in hard-to-treat B-cell lymphomas.[1] The trial is not just looking at one disease, but at several related lymphoma types in adults.[1]
Because the study is Phase 1/2 and has a small planned enrollment, it is mainly designed to gather early information rather than provide final proof of benefit.[1]
