Open-label, Single-arm Exploratory Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of JCXH-213 in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of JCXH-213, an mRNA-LNP based in vivo CAR therapy, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. This open-label, single-arm exploratory trial focuses on patients with confirmed CD19-positive B-cell Hodgkin lymphoma, including various subtypes such as diffuse large B-cell lymphoma and follicular lymphoma. The study aims to better understand the treatment's potential in this difficult-to-treat population. Participants will receive JCXH-213 infusions during the treatment observation period, which includes four dose groups following an accelerated titration dose escalation pattern combined with a "3 + 3" design. After this period, patients may continue treatment if there are no major safety concerns and their investigator agrees they may still benefit. This approach allows careful monitoring of dose-limiting toxicities within 21 days after the first infusion. Throughout the study, participants will be monitored for adverse effects and treatment response. Researchers will assess dose-limiting toxicity as the primary outcome measure. Patients must have measurable lesions and a good performance status to participate. The trial lasts through treatment and observation, with ongoing safety and benefit evaluations. The study is sponsored by Beijing GoBroad Hospital and plans to complete by December 2026.

One Trial to Evaluate the Safety, Tolerability and Efficacy of JCXH-213 in Patients With r/r B-NHL