Table of contents
- Clinical trial overview
- Who the trial is for
- Study design and phase
- What the trial measures
- Treatments used in the study
- How results are read
Clinical trial overview
This authorised interventional study is testing HSP-CAR30 in people with relapsed or refractory CD30+ lymphoma.[1]
The trial includes classical Hodgkin lymphoma and non-Hodgkin T-cell lymphoma that are CD30+.[1]
The brief study goal is to evaluate the safety and toxicity of HSP-CAR30 cell administration.[1]
Who the trial is for
The trial is for patients with disease that is either relapsed or refractory.[1]
Relapsed means the cancer came back after treatment, while refractory means it did not respond well to treatment.[1]
Only patients who receive the infusion of HSP-CAR30 cells can be evaluated for response.[1]
Patients who do not have detectable disease by PET-CT in the 30 days before infusion are not counted in the response analysis.[1]
Study design and phase
This is an interventional study, which means the research team gives a treatment and then watches what happens.[1]
The trial is in phase 1/2, so it is designed to look at early safety and early signs that the treatment may help.[1]
The planned enrollment is 40 patients.[1]
What the trial measures
The main safety endpoint is dose-limiting toxicity (DLT), which means side effects serious enough to limit the dose that can be given.[1]
Researchers will calculate the proportion of patients with DLT in the first month after infusion, with a 95% confidence interval.[1]
The study also collects data on the type and frequency of adverse events (AEs) from infusion until 30 days later.[1]
Another endpoint is response, measured as the percentage of responses, including RC, RP, and RG, using RECIL 2017 criteria.[1]
Response analysis is only for patients who actually receive HSP-CAR30 cells.[1]
Treatments used in the study
The intervention list includes HSP-CAR30 and several other medicines given by intravenous infusion.[1]
These include Fludarabina Accord, Levact, RoActemra, and Genoxal, all listed as infusion treatments in the trial data.[1]
The source data does not give more detail on how each of these medicines is used in the study, so the main focus here is the trial of HSP-CAR30 itself.[1]
How results are read
The study uses RECIL 2017 criteria to judge response, which is a set of rules for measuring how lymphoma changes after treatment.[1]
The trial also uses PET-CT before infusion to check whether disease is detectable.[1]
These measures help researchers understand both safety and early signs of benefit in this patient group.[1]
