Condition: Relapsed/Refractory B-cell Non-Hodgkin Lymphoma · Sponsor: Suzhou Immunofoco Biotechnology Co., Ltd
A phase I/IIa, open-label, single-center, dose-escalation and dose-expansion study to evaluate the safety, tolerability, and preliminary efficacy of IMV101 as a single agent in subjects with relapsed/refractory B-cell non-Hodgkin Phase I:To observe and evaluate the safety and tolerability of IMV101 in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma. Phase IIa:To determine the Recommended Phase II Dose (RP2D) based on integrated safety and efficacy data following IMV101 treatment. To evaluate the preliminary antitumor efficacy of IMV101. Secondary Study Objectives:To evaluate other safety parameters following IMV101 treatment. To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) profiles following administration of IMV101. Exploratory Objective:To evaluate biomarkers change pre- and post-IMV101 administration and their correlation with efficacy and safety. To perform long-term follow-up for immunogenicity analysis, viral shedding studies, tumor multi-omics research, lentiviral integration sites, and replication-competent lentivirus (RCL), among others.
This description comes directly from the study's public registry record.
Hongyan Tong, Doctor of Medicine · 0571-87235589 · hongyantong@aliyun.com
Chunmei Yang, Doctor of Medicine · 0571-87235589 · yangchunmei2008@163.com
Always discuss trial participation with your own doctor first.
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing, Beijing Municipality, China | Not Yet Recruiting |
| Beijing GoBroad Boren Hospital | Beijing, Beijing Municipality, China | Not Yet Recruiting |
| Zhengzhou Yihe Hospital | Zhengzhou, Henan, China | Recruiting |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou, Zhejiang, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07376642